COVID-19 Testing: Frequently Asked Questions

August 11, 2020 – September 16, 2021 R46481

COVID-19 Testing: Frequently Asked Questions September 16, 2021
The United States has at times reported some of the highest numbers of cases and deaths from the
Coronavirus Disease 2019 (COVID-19) pandemic globally, and the disease has affected and
Amanda K. Sarata,
continues to affect communities nationwide. In response, federal, state, and local governments
Coordinator
have undertaken containment and mitigation efforts to increase the efficacy of isolation and
Specialist in Health Policy
quarantine policies, reduce the impact of COVID-19 related hospitalizations, and support

targeted mitigation efforts while the vaccine rollout continues. The highly transmissible Delta
variant is challenging progress made in containing the pandemic, and the public health
Elayne J. Heisler,
Coordinator
community is taking steps to respond to and attempt to limit the spread of this variant, which
Specialist in Health
currently accounts for almost all new COVID-19 cases in the United States.
Services

Diagnostic testing is a critical part of the clinical management of COVID-19, which is caused by
the SARS-CoV-2 virus. Testing for public health purposes is also an important factor in

responding to and managing the pandemic. Although demand for testing has generally decreased
since vaccines became widely available, testing continues to be part of efforts to monitor the prevalence of COVID-19, as
well as community-level outbreaks; to identify and track the emergence of new COVID-19 variants of concern; and to help
guide mitigation measures and support a safe return to work and school as vaccine administration continues. The use of
testing for public health purposes rather than for the clinical diagnosis and management of individuals poses legal and policy
complications, because regulation and payment policies can differ based on how the test is used.
COVID-19 testing in the United States is provided in a number of health care and community-based settings. Insurance
coverage and payment for a given COVID-19 test can depend on a number of factors, including the entity administering the
test or processing test results, and the reason for which the test is administered. Congress, through several coronavirus
legislative packages, has enacted various insurance coverage requirements along with other funding mechanisms to help pay
for testing.
This CRS report provides answers to numerous questions related to COVID-19 testing, including
 types of testing available and their reliability;
 testing capacity and infrastructure;
 delivery of testing, including the settings where testing is available;
 payment for testing, including the provision by federally operated health systems and payment by federal
and private payors and payment sources available for people who are uninsured;
 federal funding for testing infrastructure and for the clinical provision of COVID-19 testing; and
 reporting of test results.
This report concludes with several appendices: Appendix A identifies acronyms used in this report, Appendix B lists CRS
experts on the various testing topics discussed, and Appendix C provides testing-related resources.
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link to page 72 COVID-19 Testing: Frequently Asked Questions

Introduction
The United States has at times reported some of the highest numbers of cases and deaths from the
Coronavirus Disease 2019 (COVID-19) pandemic global y, and the disease has affected and
continues to affect communities nationwide. In response, federal, state, and local governments
have undertaken containment and mitigation efforts to increase the efficacy of isolation and
quarantine policies, reduce the impact of COVID-19 related hospitalizations, and support targeted
mitigation efforts while the vaccine rollout continues. The highly transmissible Delta variant—
which currently accounts for nearly al new U.S. cases of COVID-19—is chal enging progress
made in containing the pandemic, and the public health community is taking steps to learn about,
respond to, and attempt to limit the spread of this variant.1
Diagnostic testing is a critical part of the clinical management of COVID-19, which is caused by
the SARS-CoV-2 virus. Testing for public health purposes is also an important factor in
responding to and managing the pandemic. With the rapid development, authorization, and
administration of several highly effective vaccines, demand for testing has general y decreased,
but it remains key to managing the pandemic broadly and to guiding clinical management of the
disease. Although demand for testing has general y decreased since vaccines have become widely
available, testing continues to be part of efforts to monitor the prevalence of COVID-19, as wel
as community-level outbreaks; to identify and track the emergence of new COVID-19 variants of
concern; and to help guide mitigation measures and support a safe return to work and school as
vaccine administration continues. In addition, testing may be used to identify breakthrough
infections in the vaccinated population, to identify and isolate positive cases of COVID-19 in
individuals who are asymptomatic, and as part of contact tracing efforts. The use of testing for
public health purposes rather than for the clinical diagnosis and management of individuals poses
legal and policy complications, because regulation and payment policies can differ based on how
the test is used.
Further, COVID-19 testing in the United States is provided in a number of health care and
community-based settings. Insurance coverage and payment for a given COVID-19 test can
depend on a number of factors, including the entity administering the test or processing test
results, and the reason for which the test is administered. These factors can determine whether a
certain funding source or payment mechanism may be used to pay for a given test. Congress,
through several coronavirus legislative packages2, has enacted various insurance coverage
requirements along with other funding mechanisms to help pay for testing.
This report provides answers to numerous questions related to COVID-19 testing. These include,
among others, questions about the types of tests and their uses, where individuals can access
testing, funding for testing-related efforts, and how different payers wil reimburse providers for
testing. As testing for various purposes is now widely available, questions continue to arise about
the settings where people can access testing, and how payment for such testing and
accompanying services occurs. Appendix C provides a list of testing-related resources; it wil be
updated as additional information becomes available or additional issues arise.
This report does not address issues related to the development and regulation of COVID-19 tests.
For information about those issues, see
 CRS In Focus IF11389, FDA Regulation of Laboratory-Developed Tests (LDTs);

1 CDC, “Monitoring Variant Proportions,” https://covid.cdc.gov/covid-data-tracker/#variant-proportions.
2 T hese laws are P.L. 116-123, P.L. 116-127, P.L. 116-136, P.L. 116-139, P.L. 116-260, and P.L. 117-2.
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COVID-19 Testing: Frequently Asked Questions

 CRS Insight IN11548, HHS Announcement on FDA Premarket Review of
Laboratory-Developed Tests (LDTs);
 CRS In Focus IF10745, Emergency Use Authorization and FDA’s Related
Authorities;
 CRS In Focus IF11789, COVID-19 Variants: Vaccines, Diagnostics, and
Therapeutics;
 CRS Report R46261, Early Development and Regulation of Diagnostic Testing
for COVID-19: Frequently Asked Questions
 CRS In Focus IF11516, COVID-19 Testing: Key Issues; and
 CRS Report R46427, Development and Regulation of Medical Countermeasures
for COVID-19 (Vaccines, Diagnostics, and Treatments): Frequently Asked
Questions.
Although this report addresses public and private payment for testing, it does not address
payment or other issues related to COVID-19 treatment or vaccination. For information about
those issues, see
 CRS Report R46316, Health Care Provisions in the Families First Coronavirus
Response Act, P.L. 116-127;
 CRS Report R46334, Selected Health Provisions in Title III of the CARES Act
(P.L. 116-136);
 CRS Report R46359, COVID-19 and Private Health Insurance Coverage:
Frequently Asked Questions;
 CRS Report R46340, Federal Response to COVID-19: Department of Veterans
Affairs;
 CRS Insight IN11273, COVID-19: The Basics of Domestic Defense Response;
 CRS Insight IN11333, COVID-19 and the Indian Health Service;
 CRS Insight IN11367, Federal Health Centers and COVID-19;
 CRS Insight IN11438, The COVID-19 Health Care Provider Relief Fund;
 CRS Insight IN11609, COVID-19 Vaccine: Financing for Its Administration;
 CRS Report R46715, FEMA Assistance for Vaccine Administration and
Distribution: In Brief;
 CRS Insight IN11617, Unauthorized Immigrants’ Access to COVID-19 Vaccines;
 CRS Report R46711, U.S. Public Health Service: COVID-19 Supplemental
Appropriations in the 116th Congress;
 CRS Report R46777, American Rescue Plan Act of 2021 (P.L. 117-2): Private
Health Insurance, Medicaid, CHIP, and Medicare Provisions; and
 CRS Report R46834, American Rescue Plan Act of 2021 (P.L. 117-2): Public
Health, Medical Supply Chain, Health Services, and Related Provisions
Other CRS products on COVID-19 are available at https://www.crs.gov/resources/coronavirus-
disease-2019.
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link to page 12 COVID-19 Testing: Frequently Asked Questions

COVID-19 Testing Overview
COVID-19 testing—including its development, regulation, and availability—has been a central
and ongoing issue throughout the COVID-19 public health emergency. Early efforts to develop a
national test, led by the Centers for Disease Control and Prevention (CDC), enc ountered
chal enges.3 Actions taken by the Food and Drug Administration (FDA) to increase the flexibility
of COVID-19 in vitro diagnostics (IVDs) regulation4 facilitated access to testing, but also created
an environment of uncertainty for commercial manufacturers and clinical laboratories, as wel as
for health care providers and patients.5 Issues have arisen around the accuracy of tests, their uses,
and the settings in which they may be used for clinical purposes, as wel as for nondiagnostic
purposes such as screening. In addition, considerations regarding these issues may vary based on
whether a test is diagnostic, and specifical y a molecular or an antigen test, or serologic .
What Are the Different Types of COVID-19 Tests?
General y, coronavirus diagnostics (IVDs) may be molecular, serological, or antigen tests.6 From
a technical perspective, tests are characterized by their methods, as wel as by the substance they
directly identify: antigens,7 antibodies,8 or viral nucleic acid. Initial y in the pandemic,
development of COVID-19 tests was largely focused on molecular tests, and specifical y tests
using a technique cal ed Polymerase Chain Reaction (PCR), and secondarily on serology tests,
those tests that identify the presence of antibodies to the SARS-CoV-2 virus. As FDA shifted to
prioritize the review of point-of-care tests, which are usual y antigen tests, in order to increase the
scale of testing and also to focus on screening, numerous such tests have been authorized by the
FDA.9 This type of test directly identifies the presence of a SARS-CoV-2 antigen, or protein,
through the use of SARS-CoV-2 antibodies which preferential y bind to the SARS-CoV-2
antigen.
From a clinical perspective, tests may be used to diagnose an active infection (by detecting the
virus directly) or a prior infection (by detecting antibodies to the virus). Molecular and antigen
tests are used to diagnose current infection, whereas serology tests are used to determine prior
infection.10 Table 1 provides a summary of the types of tests, their uses, and accuracy.

3 See CRS Report R46261, Early Development and Regulation of Diagnostic Testing for COVID-19: Frequently Asked
Questions.
4 See CRS In Focus IF11516, COVID-19 Testing: Key Issues.
5 Medium, “Regulatory uncertainty made COVID responses difficult,” April 6, 2020, https://medium.com/cgo-
benchmark/regulatory-uncertainty-made-covid-responses-difficult-c7e6e5e8f7c3.
6 FDA, “Coronavirus T esting Basics,” https://www.fda.gov/consumers/consumer-updates/coronavirus-testing-basics.
7 An antigen is defined by the National Cancer Institute (NCI) as follows: “ Any substance that causes the body to make
an immune response against that substance. Antigens include toxins, chemicals, bacter ia, viruses, or other substances
that come from outside the body,” https://www.cancer.gov/publications/dictionaries/cancer-terms/def/antigen.
8 An antibody is defined by NCI as follows: “A protein made by plasma cells (a type of white blood cell) in response to
an antigen (a substance that causes the body to make a specific immune response). Each antibody can bind to only one
specific antigen. T he purpose of this binding is to help destroy the antigen,” https://www.cancer.gov/publications/
dictionaries/cancer-terms/def/antibody.
9 Food and Drug Administration (FDA), “In Vitro Diagnostics EUAs - Antigen Diagnostic T ests for SARS-CoV-2,”
https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-
devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2. [An EUA is an emergency use authorization.]
10 FDA, “Serology/Antibody T ests: FAQs on T esting for SARS-CoV-2,” https://www.fda.gov/medical-devices/
coronavirus-covid-19-and-medical-devices/serologyantibody-tests-faqs-testing-sars-cov-2.
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COVID-19 Testing: Frequently Asked Questions

Molecular Diagnostic Testing
Molecular diagnostic testing for COVID-19 general y relies on nucleic acid amplification
techniques (NAATs), such as PCR, to detect viral genetic material. These tests identify viral
nucleic acid in samples taken from individuals’ noses or throats using swabs and are technical y
complex but wel characterized, general y requiring both specific instruments and highly trained
laboratory personnel. PCR-based testing involves sample collection (usual y a swab, as noted),
viral nucleic acid extraction, and direct testing to identify the presence of the SARS-CoV-2 viral
nucleic acid through reverse transcription, amplification, and detection techniques. PCR tests may
be high-throughput, whereby many samples may be run simultaneously in a central laboratory; in
that case, the run time is general y several hours. PCR or other NAAT-based tests may also be
point-of-care tests, which are typical y faster and simpler to run, but often run only a single or a
few samples at one time. Molecular tests may use other technologies to identify viral nucleic acid,
including for example, CRISPR, a gene-editing technology that is starting to be used in
diagnostics.11
Antigen Testing
An antigen test uses antibodies to a specific antigen (e.g., SARS-CoV-2 virus) to identify the
virus in a patient’s sample. Unlike a COVID-19 serology test, which can determine prior
infection, an antigen test can determine an active infection. This difference is accounted for by the
fact that a serology test identifies antibodies, a product of the immune response whose generation
lags infection, whereas an antigen test directly identifies the virus. Rapid antigen tests—numerous
of which have been authorized for use in the United States for COVID-1912—can detect viral
antigens, general y in a throat or nose swab. These tests, used for diagnostic purposes, are usual y
point-of-care, relatively low-cost, and easy to manufacture and use. Because of these
characteristics, this type of test is considered a good candidate for screening in asymptomatic
individuals who are not suspected of being infected, in addition to clinical diagnosis. However,
they tend to be less accurate than molecular diagnostic tests.
Serology Testing
A COVID-19 serology test identifies antibodies to the SARS-CoV-2 virus, usual y in an
individual blood sample. Antibodies are proteins generated by the immune system in response to
an antigen, or foreign substance, and their generation lags infection by a week or more. An
antigen may be a pathogenic virus or bacteria, for example, or general y any substance recognized
by the immune system as both foreign and harmful. Serology tests for SARS-CoV-2 indicate
exposure to and recovery from prior infection with the virus. The FDA has stated that such tests
are not authorized to be used alone for the diagnosis of COVID-19.13 However, serology testing
may be used to identify individuals who can donate convalescent plasma14 as a possible

11 FDA, “Coronavirus (COVID-19) Update: Daily Roundup May 7, 2020,” May 7, 2020, https://www.fda.gov/news-
events/press-announcements/coronavirus-covid-19-update-daily-roundup-may-7-2020; Also see CRS Report R44824,
Advanced Gene Editing: CRISPR-Cas9.
12 Food and Drug Administration (FDA), “In Vitro Diagnostics EUAs - Antigen Diagnostic T ests for SARS-CoV-2,”
https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-
devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2.
13 FDA, “Serology/Antibody T ests: FAQs on T esting for SARS-CoV-2,” https://www.fda.gov/medical-devices/
coronavirus-covid-19-and-medical-devices/serologyantibody-tests-faqs-testing-sars-cov-2.
14 Convalescent plasma refers to blood plasma that is collected from an individual who has recovered (i.e.,
“convalesced”) from a disease, in this case COVID-19, and then administered to a patient actively sick with COVID-19
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COVID-19 Testing: Frequently Asked Questions

therapeutic, to help guide development of a vaccine, and to determine the extent and spread of
COVID-19 in the general population, as wel as the true infection fatality rate. In addition, as
scientists learn more about the extent and duration of immunity that antibodies may confer after
natural infection, serology testing could be informative about a given individual’s immunity. The
FDA issued a safety communication in May 2021 noting that currently, serology testing is not
recommended to assess immunity in individuals who have received a vaccination, for several
reasons including, for example, that not al authorized serology tests identify the specific
antibodies that are generated in response to a vaccination.15
For What Purposes Is COVID-19 Testing Used?
Broadly, testing may be used for surveil ance, screening, or diagnosis.16 Surveillance may be used
to provide information at a population or community level; it does not general y guide decisions
at the individual level, nor are results of surveil ance testing general y returned to the individual
as samples are anonymized. Surveil ance testing may guide decisions, for example, about
population-level public health mitigation or other measures. Such testing may employ serology
testing to help determine the proportion of a given population or subpopulation that has had and
recovered from coronavirus infection, or it may use diagnostic testing to provide early indicators
of emerging outbreaks or population-level estimates of the number of individuals with current
COVID-19 infections.
Screening is typical y carried out in individuals who are asymptomatic and who have no reason to
believe that they are currently infected (e.g., due to recent exposure or travel history). Screening
can identify individuals who are infected but have no symptoms (asymptomatic) or those
individuals who are infected but are not yet showing symptoms (presymptomatic). This type of
testing is general y done in groups of individuals, such as students at a school or employees in a
workplace, as a way to preempt and prevent the spread of disease to others rather than to inform
treatment for an individual. Although screening in the case of COVID-19 in a setting such as a
workplace or a school can guide decisions about individuals—for example, whether they should
stay home or self-isolate for a period of time—it does not necessarily guide clinical decisions
about an individual’s care. Screening may use molecular- or antigen-based tests to directly detect
the presence of the virus, and this type of testing would general y be confirmed with additional
testing were an individual to begin to show symptoms.
Final y, diagnosis involves a molecular or antigen test to directly test for the presence of the virus,
either in the presence of signs or symptoms, or with a reason to suspect that an individual may be
actively infected with SARS-CoV-2 (e.g., a recent exposure to a confirmed case). Such testing
would guide clinical decisions and disease management at the individual level. Serology tests are
not currently used for clinical diagnostic purposes or to establish the exclusion of infection, per
relevant FDA guidance on diagnostic testing for COVID-19 during the COVID-19 emergency
period.17

for treatment. See CRS Report R46375, The U.S. Blood Supply and the COVID-19 Response: In Brief.
15 FDA, “Antibody T esting Is Not Currently Recommended to Assess Immunity After COVID-19 Vaccination: FDA
Safety Communication,” May 19, 2021, https://www.fda.gov/medical-devices/safety-communications/antibody-testing-
not-currently-recommended-assess-immunity-after-covid-19-vaccination-fda-safety.
16 For a high-level overview of these three types of testing, see FDA, “COVID-19 T est Uses: FAQs on T esting for
SARS-CoV-2,” https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/covid-19-test-uses-
faqs-testing-sars-cov-2.
17 FDA, “Policy for Coronavirus Disease-2019 T ests During the Public Health Emergency (Revised),” May 11, 2020,
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COVID-19 Testing: Frequently Asked Questions

When Is COVID-19 Testing Clinically Useful?
The answer to this question depends on the type of test and the circumstances of the testing.
Serology testing at the current time is not general y clinical y useful for the treatment or
management of COVID-19 at an individual level.18 Moreover, serology testing does not provide
reliable information about an active, current infection, nor does it currently provide information
about immunity to reinfection. The mechanism of the immune response to infection with SARS-
CoV-2—whether antibodies provide immunity and, if so, for what duration, and what level of
antibody might be required for this effect—is largely unknown at this time.19 In certain fact-
specific cases, serology testing results may inform clinical treatment or management, but these
cases are not the norm.
Molecular diagnostic or rapid antigen testing is clinical y useful in the presence of signs or
symptoms, or in the context of a known or suspected exposure. This type of testing in the absence
of any reason to suspect infection, or in the absence of signs or symptoms of il ness, is general y
not clinical y useful. Individuals who receive a positive result in this case may be either
asymptomatic (meaning they are infected but are not exhibiting symptoms of the disease) or
presymptomatic (meaning they are infected but have not yet begun to show clinical signs or
symptoms of the disease). In the case of an asymptomatic case, no clinical treatment wil be
needed, so the test result is not clinical y useful for that individual. In the case of a
presymptomatic case, once the tested individual begins to exhibit symptoms, clinical treatment
may become necessary, but testing would likely be repeated at that time to confirm the diagnosis.
At this time, there is an authorized therapeutic option for individuals who have been exposed to a
confirmed positive COVID-19 case, but are asymptomatic or presymptomatic (post-exposure
prophylaxis).20 In this context, screening tests could potential y be used to guide the clinical
decision to give an exposed individual treatment to prevent further COVID-19 transmission to
others and/or severe health outcomes.
Do New Variants Affect COVID-19 Diagnostic Testing?
Currently, the Delta variant is the dominant variant of the SARS-CoV-2 virus circulating in the
country.21 This variant is more transmissible than previous variants, and is currently accounting
for almost al new COVID-19 cases. COVID-19 diagnostic testing focuses on detecting the
presence or absence of infection with the SARS-CoV-2 virus, including detecting the absence or
presence of infection with variants of the virus.
Diagnostic testing general y does not identify the specific variant of the virus causing infection,
such as the Delta variant. That distinction requires sequencing of the viral genome, which is not
part of most authorized COVID-19 tests, nor is it relevant to clinical treatment of patients.

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-coronavirus-disease-2019-tests-
during-public-health-emergency-revised.
18 See for example, the American Medical Association, “Serological testing for SARS-CoV-2 antibodies,” May 14,
2020, https://www.ama-assn.org/delivering-care/public-health/serological-testing-sars-cov-2-antibodies.
19 FDA, “Antibody (Serology) T esting for COVID-19: Information for Patients and Consumers,” https://www.fda.gov/
medical-devices/coronavirus-covid-19-and-medical-devices/antibody-serology-testing-covid-19-information-patients-
and-consumers.
20 FDA, “FDA authorizes REGEN-COV monoclonal antibody therapy for post-exposure prophylaxis (prevention) for
COVID-19,” https://www.fda.gov/drugs/drug-safety-and-availability/fda-authorizes-regen-cov-monoclonal-antibody-
therapy-post-exposure-prophylaxis-prevention-covid-19, August 10, 2021.
21 CDC, “Monitoring Variant Proportions,” https://covid.cdc.gov/covid-data-tracker/#variant-proportions.
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COVID-19 Testing: Frequently Asked Questions

Genomic surveil ance, which is used to identify and type specific variants, is carried out by
sequencing a specific subset of tested positive patient samples. The Food and Drug
Administration (FDA) monitors relevant EUA-authorized COVID-19 tests to ensure that they
continue to perform accurately when chal enged with new virus variants.22
How Accurate Are Diagnostic and Serology Tests?
The accuracy of diagnostic testing is primarily determined by assessing two test performance
characteristics: (1) the ability of the test to identify true positives (people with disease) and (2) the
ability of the test to identify true negatives (people without the disease). These are referred to as
sensitivity—the ability to detect a true positive—and specificity—the ability to detect a true
negative.23 A test with high sensitivity wil have a low rate of false negatives, whereas a test with
high specificity wil have a low rate of false positives. A test’s reliability in clinical diagnosis wil
be affected by the prevalence of the disease in the population or community, and specifical y, in
lower prevalence settings, tests return higher rates of false positives, and in higher prevalence
settings, tests return higher rates of false negatives, even if the test has relatively high sensitivity
and specificity.24 The test is performing as expected in these circumstances, but clinicians and
others weigh these considerations when interpreting results. These distinctions have different
implications in the context of an infectious disease; specifical y, a false negative may result in the
unknowing transmission of the disease to others, whereas a false positive may result in incorrect
therapeutic treatment decisions or unnecessary use of Personal Protective Equipment (PPE),
among other things.
Accuracy concerns have arisen with respect to both diagnostic and serological COVID-19
testing.25 With respect to molecular diagnostic testing for COVID-19, tests are general y highly
specific (i.e., false positives are unlikely) but problems can occur with respect to sensitivity, or
false negatives. Relevant research indicates that the false negative rate for PCR tests varies based
on the timing of the test, with the most accurate testing occurring approximately three days after
the onset of symptoms.26 Although no diagnostic test performs with perfect accuracy, certain
issues may result in lower accuracy. PCR-based tests are usual y accurate and wil general y
reliably identify viral nucleic acid, if it is present in amounts above the limit of detection for a
given diagnostic. However, problems can occur with sampling technique, storage, and transport
of the sample (e.g., over-dilution, temperature maintenance).27 In addition, viral load varies
during the course of an infection by site (e.g., throat, nose), thereby affecting the amount of virus
present in a collected sample, which can in turn affect the test results.
In terms of accuracy, serology tests may have issues with specificity and the return of false
positive results. This inaccuracy may occur because cross-reactivity with antibodies from

22 For more information, see CRS In Focus IF11789, COVID-19 Variants: Vaccines, Diagnostics, and Therapeutics.
23 Cochrane UK, “ Sensitivity and specificity explained: A Cochrane UK T rainees blog,” https://uk.cochrane.org/news/
sensitivity-and-specificity-explained-cochrane-uk-trainees-blog.
24 T akashi Asai, “COVID-19: accurate interpretation of diagnostic tests—a statistical point of view,” Journal of
Anesthesia, December 11, 2020, https://link.springer.com/article/10.1007/s00540-020-02875-8.
25 S. Woloshin et al., “False Negative T ests for SARS-CoV-2 Infection—Challenges and Implications,” New England
Journal of Medicine, 383(6), August 6, 2020, https://www.nejm.org/doi/full/10.1056/NEJMp2015897.
26 LM Kucirka et al., “Variation in False-Negative Rate of Reverse T ranscriptase Polymerase Chain Reaction –Based
SARS-CoV-2 T ests by T ime Since Exposure,” Annals of Internal Medicine, May 13, 2020,
https://www.acpjournals.org/doi/10.7326/M20-1495.
27 FDA, “Coronavirus T esting Basics (Molecular T ests),” https://www.fda.gov/consumers/consumer-updates/
coronavirus-testing-basics.
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commonly circulating coronaviruses or other viruses can return false positives (the result is not
specific enough to SARS-CoV-2).28 Beginning in early 2020, serology tests were al owed to be
marketed and used without an Emergency Use Authorization (EUA),29 which contributed to
uncertainty about how wel these tests performed initial y.30 In response to this early experience,
the FDA began working with other federal agencies (e.g., the National Institutes of Health (NIH))
to provide independent validation for these tests,31 and it modified its guidance to require
manufacturers to receive authorization for commercial y manufactured and marketed serology
tests.32
Table 1. Summary of COVID-19 Testing Types, Uses, and Accuracy
Appropriate for
Type of
What it
Approval
Accuracy
test
tests for
status
Diagnosis
Screening
Surveillance
issues
Molecular
Detects viral
More than
Yes
Yes (e.g.,
Yes (for
False negatives
genetic material
250 EUA
workplace
outbreaks)
may occur
authorized
or school
where samples
tests
testing)
have low
amounts of virus
Serological
Detects serum
More than
No
No
Yes (for
False positives
antibodies
80 EUA
prevalence
may occur from
authorized
estimates)
cross-reactivity
tests
of antibodies
from non-SARS-
CoV-2 common
coronaviruses
Antigen
Detects viral
About 30
Yes
Yes (e.g.,
Yes (for
Rates of false
antigen
EUA
workplace
outbreaks)
negatives tend
authorized
or school
to be higher
tests
testing)
than for
molecular
diagnostics
Sources: CRS Analysis of “What Are the Different Types of COVID-19 Tests?,” and FDA, “In Vitro Diagnostics
EUAs,” https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-
medical-devices/vitro-diagnostics-euas.
Note: EUA = emergency use authorization.

28 FDA, “Coronavirus (COVID-19) Update: Serological T est Validation and Education Efforts,” April 18, 2020,
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-serological-test-validation-and-
education-efforts.
29 An EUA is an authorization granted by the FDA when certain conditions are met (e.g., a public health emergency)
that allows an unapproved medical product to be marketed and used clinically. For more information about the EUA
mechanism, see CRS In Focus IF10745, Em ergency Use Authorization and FDA’s Related Authorities.
30 FDA, “ Insight into FDA’s Revised Policy on Antibody T ests: Prioritizing Access and Accuracy,” May 4, 2020,
https://www.fda.gov/news-events/fda-voices/insight-fdas-revised-policy-antibody-tests-prioritizing-access-and-
accuracy.
31 FDA, “Serology/Antibody T ests: FAQs on T esting for SARS-CoV-2,” https://www.fda.gov/medical-devices/
coronavirus-covid-19-and-medical-devices/serologyantibody-tests-faqs-testing-sars-cov-2.
32 FDA, “Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug
Administration Staff,” May 11, 2020, https://www.fda.gov/media/135659/download.
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Testing Capacity and Infrastructure
For much of the pandemic, prior to availability of vaccines and multiple types of EUA authorized
COVID-19 tests, demand for testing for COVID-19—including for diagnostic, screening and
surveil ance purposes—placed significant strain on both the clinical laboratory infrastructure in
the United States and on the testing supply chain.33 This stress continued as late as early spring
2021, and has recently reemerged as the Delta variant spreads and case counts rise again.34
During the pandemic, clinical laboratories reported that the supply chain was stressed at almost
every point, and that access to testing and testing turn-around time varied across the country, with
excess capacity in some areas and excess demand in others.35
Clinical diagnostic testing is carried out by a network of private and public laboratories, as wel
as at the point of care by health care providers in health care settings. Clinical laboratories include
large commercial reference laboratories (e.g., Quest); academic and university laboratories (e.g.,
University of Washington Medicine Virology Laboratory36); and hospital and other clinical
laboratories. Testing is also carried out by CDC and other federal laboratories and the U.S.
network of state and local public health laboratories, including some Department of Defense
(DOD) and international laboratories.37 Tests authorized for use at the point of care may be used
in health care or other settings that have appropriate CLIA certification, an option which has
helped ease strain on the clinical laboratory infrastructure.
In April 2020, the Trump Administration released the Testing Blueprint: Opening Up America
Again; this report outlined three core areas which aimed to “enable State and local officials to
quickly isolate cases, respond to local outbreaks, and create confidence that citizens are safe to
engage in social and business activities,” including Diagnostic Testing Plans, Timely Monitoring
Systems and Rapid Response Programs.38 In late May 2020, and again in August and November
of 2020, the Department of Health and Human Services (HHS) released a national testing strategy
report compiling certain testing-related information pursuant to a requirement in the Paycheck
Protection Program and Healthcare Enhancement Act (PPPHCEA, P.L. 116-139).39 These reports
were not required to be, nor were they, released publicly by HHS.40 The May 2020 HHS plan
deferred to states to develop testing programs and implement testing in their states.41 States and

33 American Association for Clinical Chemistry (AACC), “COVID-19 Survey Results,” https://www.aacc.org/science-
and-research/covid-19-resources/aacc-covid-19-testing-survey/full-survey-results.
34 AACC, “New Coronavirus T esting Protocol Could Help Labs Keep Up With Rising T esting Demands as Delta
Variant Spreads,” July 21, 2021, https://www.aacc.org/media/press-release-archive/2021/07-jul/new-coronavirus-
testing-protocol-could-help-labs-keep-up-with-spread-of-delta-variant.
35 See for example, Association of Molecular Pathology, “SARS-CoV-2 Molecular T esting, Summary of Recent
SARS-CoV-2 Molecular T esting Survey,” https://www.amp.org/AMP/assets/AMP_SARS-CoV-
2_Survey_Report_FINAL.pdf?pass=28.
36 University of Washington Medicine, “UW Virology COVID-19 Dashboard,” http://depts.washington.edu/labmed/
covid19/.
37 See CDC, “Introduction to Public Health Laboratories,” https://www.cdc.gov/publichealth101/laboratories.html.
38 Homeland Security Digital Library, “T esting Blueprint: Opening America Up Again,” https://www.hsdl.org/c/
testing-blueprint -opening-america-up-again/.
39 P.L. 116-139, Division B “Additional Emergency Appropriations for Coronavirus Response,” T itle I, “Department of
Health and Human Services,” 134 ST AT . 627-628.
40 GAO, “COVID-19 Critical Vaccine Distribution, Supply Chain, Program Integrity, and Other Challenges Require
Focused Federal Attention (GAO-21-265),” January 28, 2021, https://www.gao.gov/assets/gao-21-265.pdf, p. 88.
41 Department of Health and Human Services (HHS), “COVID Strategic T esting Plan,” May 24, 2020. “T he role of the
Federal government is to enable innovation, help scale supplies, and provide strategic guidance. States, territories, and
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jurisdictions developed strategies to test their populations, specifical y with respect to the types
and amount of tests needed, as wel as their capacity and plans for overal testing, including for
diagnosis, contact tracing, surveil ance, testing in congregate or high-risk health care and
employment settings, and general workplace and school-based screening.42
What Is Point-of-Care vs. Centralized Testing?
Clinical testing may be centralized, in which a sample is collected and sent to a central laboratory
for testing, or decentralized, in which the testing occurs entirely at or near the patient or point of
care (POC), commonly referred to as point-of-care testing. The FDA notes that “point of care”
includes patient care settings such as “hospitals, physician offices, urgent care, outreach clinics,
pharmacies, and temporary patient care settings that have appropriately trained personnel to
perform the test and are operating under a CLIA Certificate of Waiver or Certificate of
Compliance.”43 In addition, the agency notes that, in general, “point of care” does not apply to at-
home testing or at-home sample collection.44 The FDA has authorized a number of molecular
diagnostic point-of-care tests (e.g., Abbott IDNow) and about 25 antigen point-of-care tests to
date (the majority of authorized antigen tests are authorized for use at the POC), although the
majority of al EUA-authorized tests are not authorized for use in a point-of-care setting.45
POC tests are particularly important in cases where an individual is seriously il and a test result
is needed quickly to care for the individual and conserve PPE, as wel as in places that are far
away from centralized laboratories—particularly rural and remote areas. POC tests are general y
noted for being faster, less expensive, less technical y complex to run, and simpler to
manufacture.46 However, these tests are also often less accurate and, in particular, may be less
sensitive, meaning they return more false negatives than a comparable non-POC molecular
diagnostic would.47 In addition, while most antigen tests are available at the point of care, they
also general y are less sensitive than molecular diagnostic tests (both laboratory-based or POC
molecular tests).
There were accuracy issues with at least one FDA-authorized POC molecular diagnostic, which
led the FDA to require confirmation of negative results with an authorized high-sensitivity

tribes are responsible for formulating and implementing testing plans; and the private sector will continue to develop
and produce technologies, supplies, and services to meet the needs of the States,” pp. 7, https://delauro.house.gov/sites/
delauro.house.gov/files/HHS_COVID_T esting_Report.pdf.
42 HHS, “HHS Releases July - December COVID-19 State T esting Plans,” https://public3.pagefreezer.com/browse/
HHS%20%E2%80%93%C2%A0About%20News/20-01-2021T 12:29/https://www.hhs.gov/about/news/2020/08/10/
hhs-releases-july-december-covid-19-state-testing-plans.html.
43 CLIA refers to the Clinical Laboratory Improvement Amendments of 1988 ( P.L. 100-578), a law that regulates all
clinical laboratories in the United States. For more information, see https://www.cms.gov/Regulations-and-Guidance/
Legislation/CLIA.
44 FDA, “COVID-19 T est Settings: FAQs on T esting for SARS-CoV-2,” https://www.fda.gov/medical-devices/
coronavirus-covid-19-and-medical-devices/covid-19-test-settings-faqs-testing-sars-cov-2.
45 FDA, “In Vitro Diagnostics EUAs,” https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-
emergency-use-authorizations-medical-devices/vitro-diagnostics-euas.
46 National Academy of Sciences, “Rapid Expert Consultation on SARS-CoV-2 Laboratory T esting for the COVID-19
Pandemic (April 8, 2020),” https://www.nap.edu/catalog/25775/rapid-expert-consultation-on-sars-cov-2-laboratory-
testing-for-the-covid-19-pandemic-april-8-2020.
47 See for example Office of the Assistant Secretary for Health, “Guidance – Proposed Use of Point -of-Care (POC)
T esting Platforms for SARS-CoV-2 (COVID-19),” https://www.cdc.gov/coronavirus/2019-ncov/downloads/OASH-
COVID-19-guidance-testing-platforms.pdf.
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molecular diagnostic.48 This highlighted the fact that the speed and cost-effectiveness associated
with POC tests may potential y be offset if additional steps are needed to mitigate accuracy
issues. However, POC diagnostics’ sensitivity can be weighed against their turnaround time and
frequency, particularly in the context of screening and surveil ance. Specifical y, research
suggests that frequent testing with a faster turnaround time is more important than test sensitivity
to effective control of virus spread. Relevant research notes that “[t]esting frequency was found to
be the primary driver of population-level epidemic control, with only a smal margin of
improvement provided by using a more sensitive test.”49 A June 2021 NIH-funded study adds to
this knowledge base, finding that antigen tests perform on par with molecular tests when taken
frequently (specifical y, every three days, in this study).50
Is There a National COVID-19 Testing Plan or Strategy?
Since early in the pandemic, there has been ongoing discussion about how to coordinate and
organize COVID-19 testing efforts in the United States. Numerous experts in public health and
medicine have weighed in on this issue, with several preparing model testing strategies and
recommending various approaches to a coordinated national plan.51 Many experts have cal ed for
a national strategy coordinated and led by the federal government;52 however, the states have
general y carried out their own testing programs and strategies, with strategic guidance from the
federal government.
In April 2020, the Trump Administration released its Testing Blueprint: Opening America Up
Again, which “describes the roles and responsibilities, as wel as core objectives, for the robust
State testing plans and rapid response programs needed by States to safely reopen.”53 Other

48 FDA notes that “negative results should be treated as presumpt ive and, if inconsistent with clinical signs and
symptoms or necessary for patient management, should be tested with different authorized or cleared molecular tests.”
See Abbott IDNow Letter of Authorization, updated September 17, 2020, https://www.fda.gov/media/136522/
download.
49 Daniel B. Larremore et al., “T est sensitivity is secondary to frequency and turnaround time for COVID -19
surveillance,” medRxiv, June 27, 2020, https://www.medrxiv.org/content/10.1101/2020.06.22.20136309v2.full.pdf.
50 NIH, “NIH-funded screening study builds case for frequent COVID-19 antigen testing,” June 30, 2021,
https://www.nih.gov/news-events/news-releases/nih-funded-screening-study-builds-case-frequent -covid-19-antigen-
testing.
51 See for example: (1) Rockefeller Foundation, “ National Covid-19 T esting & T racing Action Plan,” July 2020,
https://www.rockefellerfoundation.org/national-covid-19-testing-and-tracing-action-plan/; (2) Harvard Center for
Ethics, “ROADMAP T O PANDEMIC RESILIENCE: Massive Scale T esting, T racing, and Supported Isolation (T T SI)
as the Path to Pandemic Resilience for a Free Society,” April 20, 202 0, https://ethics.harvard.edu/files/center-for-ethics/
files/roadmaptopandemicresilience_updated_4.20.20.pdf; (3) American Enterprise Institute, “National coronavirus
response: A road map to reopening,” March 29, 2020, https://www.aei.org/research-products/report/national-
coronavirus-response-a-road-map-to-reopening/; and (4) AAMC, “ AAMC Recommendations for COVID-19 T esting:
T he Current State and T he Way Forward,” October 22, 2020, https://www.aamc.org/covidroadmap/testing.
52 See, for example, ST AT News, “T he U.S. needs a national Covid-19 testing strategy, not a state-by-state patchwork,”
October 1, 2020, https://www.statnews.com/2020/10/01/national-covid-19-testing-strategy-not-state-by-state-
patchwork/; Families USA, “ CALLING FOR A T RUE NAT IONAL T EST ING ST RAT EGY FOR COVID -19,” June
11, 2020, https://familiesusa.org/resources/calling-for-a-true-national-testing-strategy-for-covid-19/; and American
Society for Clinical Pathology, “The United States Must Develop a National COVID-19 Diagnostic T esting and
Support Strategy,” April 14, 2020, https://www.ascp.org/content/news-archive/news-detail/2020/04/14/the-american-
society-for-clinical-pathology-calls-on-the-federal-government -to-develop-a-national-covid-19-diagnostic-testing-and-
support -strategy.
53 T rump White House, “President Donald J. T rump Is Ensuring States Have T he T esting Capacity Needed T o Safely
Open Up America Again, April 27, 2020, https://trumpwhitehouse.archives.gov/briefings-statements/president -donald-
j-trump-ensuring-states-testing-capacity-needed-safely-open-america/.
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efforts were started in response to the perceived lack of national guidance on testing. For
example, in July 2020, HHS announced the launch of the National COVID-19 Testing
Implementation Forum, described as “a new program to capture feedback between federal
officials and the private sector.”54 Information about the initiative was limited. Stated goals
included gathering private sector input on end-to-end supply chain issues and implementation of a
national surveil ance strategy. In addition, several states formed a bipartisan purchasing compact
in August 2020 to procure rapid antigen tests directly from the tests’ manufacturers, bypassing the
federal government and using their combined leverage to ensure manufacturers of demand for
their product.55
PPPHCEA, enacted in late April 2020, required HHS to develop and submit to Congress a
COVID-19 strategic testing plan not later than 30 days after its enactment, and required the plan
be updated every 90 days until funds were expended.56 The plan was required to help states
understand the types of testing available for COVID-19, provide guidelines for testing and
estimates of testing production, and outline how the HHS Secretary would increase testing
capacity and testing supplies. This strategic testing plan was first submitted to designated
congressional committees on May 24, 2020. That report detailed background on the types of
COVID-19 tests, as wel as an overview of the types of laboratories carrying out testing (the
testing “ecosystem”), among other things, but it did not provide a comprehensive national testing
strategy. Additional reports were sent to Congress in August and November of 2020 in fulfil ment
of the PPPHCEA statutory requirement, although they were not released publicly.57
The PPPHCEA also required states and other jurisdictions receiving funding pursuant to the act to
submit testing plans that included the following information: the number of tests needed;
estimates of laboratory and testing capacity, including related to workforce, equipment and
supplies, and available tests; and a description of how the state, locality, territory, tribe, or tribal
organization wil use its resources for testing, including how such use relates to easing any
COVID-19 community mitigation policies.58 According to the May 2020 COVID-19 strategic
testing plan submitted by HHS to Congress, “States are requested to detail how a minimum of
two percent of the State’s population wil be tested each month beginning immediately; as wel as
plans to increase that number by the fal of 2020.”59 The state plans were initial y required to be
submitted to HHS 30 days post-enactment, but states were given an extension to May 30 for plans
covering May and June, and until June 15 for plans covering the remainder of 2020. In late June
2020, Representative Frank Pal one, Chairman of the House Committee on Energy and
Commerce, sent a letter to HHS requesting the public release of the state testing plans.60 Although

54 HHS, “HHS Announces National COVID-19 T esting Implementation Forum,” July 21 2020, https://www.hhs.gov/
about/news/2020/07/21/hhs-announces-national-covid-19-testing-implementation-forum.html.
55 Washington Post, “T here’s no national testing strategy for coronavirus. T hese states banded together to make one.”
August 4, 2020, https://www.washingtonpost.com/coronavirus/coronavirus-state-testing-compact/2020/08/04/
8b73bed8-d66f-11ea-9c3b-dfc394c03988_story.html.
56 P.L. 116-139, Division B, “Additional Emergency Appropriations for Coronavirus Response,” T itle I, Department of
Health and Human Services, 134 ST AT . 627-628.
57 GAO, “COVID-19 Critical Vaccine Distribution, Supply Chain, Program Integrity, and Other Challenges Require
Focused Federal Attention (GAO-21-265),” January 28, 2021, https://www.gao.gov/assets/gao-21-265.pdf, p. 82.
58 P.L. 116-139, Division B, “Additional Emergency Appropriations for Coronavirus Response,” T itle I, Department of
Health and Human Services, 134 ST AT . 627-628.
59 HHS, “Report to Congress: COVID-19 Strategic T esting Plan,” May 24, 2020, pp. 71-81, https://delauro.house.gov/
sites/delauro.house.gov/files/HHS_COVID_T esting_Report.pdf (hereinafter, HHS, “ COVID-19 Strategic T esting
Plan”).
60 360dx.com, “US Congressman Requests State COVID-19 T esting Plans From HHS,” June 26, 2020,
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these state plans were not required to be released publicly, HHS made them publicly available on
July 10, 2020.61
In late January 2021, the Government Accountability Office (GAO) released a report
recommending that “HHS develop and make publicly available a comprehensive national
COVID-19 testing strategy that incorporates al characteristics of an effective national strategy.”62
President Biden’s Pandemic Relief Strategy notes that widespread, accessible testing wil lead to
better public health outcomes.63 He further issued an executive order on January 20, 2021, tasking
the coordination of the federal government’s approach to COVID-19 testing to a newly created
position within the Executive Office.64 The Biden Administration has not released a national
testing strategy,65 although in September 2021, the Administration released a COVID-19 Action
Plan, which includes several actions to increase and improve access to testing, and specifical y to
at-home and POC testing.66
How Have Supply Chain-Related Issues Affected
COVID-19 Testing?
Earlier in the pandemic, there were widespread reports of supply chain issues affecting access to
COVID-19 diagnostic testing national y.67 As vaccines were administered across the country and
case counts declined, the demand and need for testing decreased, which eased many of the supply
chain stressors experienced in the beginning of the pandemic.68 In response, some manufacturers
decreased production of their tests. However, the emergence of the highly transmissible Delta
variant over the summer—combined with eased mitigation measures and reopening of schools
and workplaces—has again increased demand for testing, placing new strain on the supply of
some tests.69 Specifical y, the supply of COVID-19 at-home tests and POC tests is under some

https://www.360dx.com/infectious-disease/us-congressman-requests-state-covid-19-testing-plans-hhs#.XxY7EJ5Kg4k.
61 HHS, “HHS Releases July - December COVID-19 State T esting Plans,” https://public3.pagefreezer.com/browse/
HHS%20%E2%80%93%C2%A0About%20News/20-01-2021T 12:29/https://www.hhs.gov/about/news/2020/08/10/
hhs-releases-july-december-covid-19-state-testing-plans.html.
62 GAO, “COVID-19 Critical Vaccine Distribution, Supply Chain, Program Integrity, and Ot her Challenges Require
Focused Federal Attention (GAO-21-265),” January 28, 2021, https://www.gao.gov/assets/gao-21-265.pdf.
63 White House, “National Strategy For the Covid-19 Response and Pandemic Preparedness” January, 2021, available
at https://www.whitehouse.gov/wp-content/uploads/2021/01/National-Strategy-for-the-COVID-19-Response-and-
Pandemic-Preparedness.pdf.
64 Executive Order 12987, “ Organizing and Mobilizing the United States Government T o Provide a Unified and
Effective Response T o Combat COVID-19 and T o Provide United States Leadership on Global Health and Security, ”
86 Federal Register 7019-7021, January 20, 2021.
65 Roll Call, “Lack of national COVID testing strategy drives confusion,” April 20, 2021, https://www.rollcall.com/
2021/04/20/lack-of-national-covid-testing-strategy-drives-confusion/.
66 T he White House, “Path out of the Pandemic: President Biden’s COVID-19 Action Plan,”
https://www.whitehouse.gov/covidplan/#testing-masking%C2%A0.
67 See for example McKinsey & Company, “COVID-19: Overcoming supply shortages for diagnostic testing,” July 15,
2020, https://www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/covid-19-overcoming-
supply-shortages-for-diagnostic-testing#.
68 Pew, “U.S. COVID-19 T esting Has Dropped Dramatically,” March 22, 2021, https://www.pewtrusts.org/en/research-
and-analysis/blogs/stateline/2021/03/22/us-covid-19-testing-has-dropped-dramatically.
69 Reuters, “U.S. COVID-19 tests again in short supply as infections soar, schools reopen,” August 27, 2021,
https://www.reuters.com/world/us/us-covid-19-tests-again-short -supply-infections-soar-schools-reopen-2021-08-27/.
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stress due in part to increased demand for these products generated by increasing cases and
surveil ance testing in schools, among other things.
The supply chain for molecular diagnostics, a complex and relatively slow type of testing, is not
streamlined and has not developed to support the high-volume, rapid sample-to-answer testing
required during the pandemic. The testing industry has been described as “bespoke,”70 meaning it
has general y focused on developing tailor- or custom-made products, rather than mass
production of a uniform product. It is not central y coordinated; is composed of multiple entities;
and relies on a wide variety of platforms and instruments that are largely not interoperable. As a
result, most laboratories’ supply chains rely on a unique combination of inputs from various
manufacturers, which can be difficult to characterize and optimize.
As the FDA was granting EUAs for more laboratory-developed tests (LDTs) and test kits to meet
increasing demand and testing volume increased, laboratories across the country reported
shortages of virtual y al necessary supplies for testing. A survey of clinical laboratories across the
country conducted in December 2020 through January 2021 found that 50% of responding labs
reported chal enges obtaining necessary supplies, including test kits, reagents and swabs.71 PCR-
based molecular diagnostic testing involves sample collection, nucleic acid extraction, and testing
to identify the presence of the SARS-CoV-2 virus. Since testing began, there have been shortages
of the supplies needed for each of these steps: swabs needed for sample collection; viral transport
media needed to stabilize and store the samples after collection and during transport; ribonucleic
acid (RNA)72 extraction kits and reagents needed to extract viral RNA from the samples prior to
testing; test kits and testing reagents needed to amplify and detect viral nucleic acid; and
instruments needed to run tests. PPE needed during sample collection has similarly been in short
supply, as has laboratory space and trained personnel needed to run the tests, as wel as common
laboratory consumables (e.g., pipette tips).73
Private efforts, spearheaded by the American Society for Microbiology (ASM) and the
Association for Supply Chain Management (ASCM), national y monitored and publicly reported
on inventory and supply shortages experienced by clinical laboratories in late 2020. The most
recent data from these efforts indicated that clinical laboratories were operating at 40% of their
capacity, that key supply shortages continued (e.g., test kits, consumables), and that supplies for
non-COVID-19 testing were being affected.74 The Biden Administration’s National Strategy for
the COVID-19 Response and Pandemic Preparedness notes that the “federal government wil
identify, inventory, and monitor the need, availability, and manufacturing capacity of critical
supplies,” including for testing and PPE.75

70 Andrew Slavitt, “Here’s How T he US Can Start T esting More People for Covid-19,” May 5, 2020.
https://coronavirus.medium.com/heres-how-the-us-can-start-testing-more-people-for-covid-19-ed3f10bb9952.
71 AACC, “COVID-19 Survey Results,” https://www.aacc.org/science-and-research/covid-19-resources/aacc-covid-19-
testing-survey/full-survey-results.
72 RNA (ribonucleic acid) is defined as a “ complex compound of high molecular weight that functions in cellular
protein synthesis and replaces DNA (deoxyribonucleic acid) as a carrier of genetic codes in some viruses.”
https://www.britannica.com/science/RNA.
73 For more information, see CRS In Focus IF11774, COVID-19 Testing Supply Chain.
74 American Society for Microbiology, “Supply Shortages Impacting COVID-19 and Non-COVID T esting,” January
19, 2021, https://asm.org/Articles/2020/September/Clinical-Microbiology-Supply-Shortage-Collecti-1.
75 Biden White House, “National Strategy for the COVID-19 Response and Pandemic Preparedness,” January 21, 2021,
https://www.whitehouse.gov/wp-content/uploads/2021/01/National-Strategy-for-the-COVID-19-Response-and-
Pandemic-Preparedness.pdf.
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link to page 19 link to page 19 COVID-19 Testing: Frequently Asked Questions

Which Federal Agencies Are Involved in the Testing Supply Chain?
The FDA has worked with industry to identify and mitigate shortages by modifying test EUAs to
al ow for the use of alternate supplies when carrying out a test and by providing information for
manufacturers and laboratories relating to testing supply substitution strategies.76 However,
throughout much of the pandemic, shortages persisted due to global demand and the
unprecedented level of testing, as wel as a lack of coordinated ascertainment, production, and
al ocation of supplies. The FDA does not have the authority to al ocate or distribute supplies.
By virtue of the national emergency, Federal Emergency Management Agency (FEMA) has
played a key federal role in procuring and distributing testing supplies (see the “What Is FEMA’s
Role in Distributing Testing Materials to Providers?” section of this report), and the Defense
Production Act (DPA) is an available mechanism for compel ing production of testing supplies. 77
For example, President Trump invoked the DPA for the production of nasal swabs, and the
Department of Defense announced $75 mil ion in DPA investments to increase nasal swab
production.78 The Assistant Secretary for Preparedness and Response (ASPR) at HHS also has a
significant role in supply chain issues for medical countermeasures in public health emergencies,
including, for example, through the management of the Strategic National Stockpile.79
What Is FEMA’s Role in Distributing Testing Materials to Providers?
During the early pandemic response, FEMA procured and distributed testing materials directly to
states, tribes, territories, local governments, and nonprofit medical facilities to expand testing
capacity.80 In the first half of 2020, FEMA and HHS also led the Laboratory Diagnostics Task
Force, which supports testing efforts undertaken by state and local governments, health care
providers, and public health labs.81 In June 2020, this task force was reorganized under HHS
oversight.82
General y, FEMA may provide personnel, supplies, and operational support for urgent response
work to states, tribes, territories, local governments, and eligible private nonprofit organizations
(Applicants) authorized to receive Public Assistance (PA) under a Stafford Act declaration; this
assistance is referred to as Direct Federal Assistance.83 When warranted, FEMA tasks its own
personnel or other federal agencies, such as HHS and CDC, to perform work or provide supplies

76 FDA, “COVID-19 T esting Supplies: FAQs on T esting for SARS-CoV-2,” https://www.fda.gov/medical-devices/
coronavirus-covid-19-and-medical-devices/covid-19-testing-supplies-faqs-testing-sars-cov-2.
77 For more information about the Defense Production Act, see CRS Insight IN11387, COVID-19: Defense Production
Act (DPA) Developm ents and Issues for Congress.
78 Department of Defense (DOD), “DOD Details $75 Million Defense Production Act T itle 3 Puritan Contr act,” April
29, 2020, https://www.defense.gov/Newsroom/Releases/Release/Article/2170355/dod-details-75-million-defense-
production-act-title-3-puritan-contract/.
79 See “HHS Office of the Assistant Secretary for Preparedness and Response,” https://www.phe.gov/about/aspr/Pages/
default.aspx.
80 Federal Emergency Management Agency (FEMA), “Federal Support to Expand National T esting Capabilities,” May
5, 2020, https://www.fema.gov/fact-sheet/federal-support -expand-national-testing-capabilities (hereinafter FEMA,
“Federal Support to Expand National T esting Capabilities”).
81 Ibid.
82 FEMA, Pandemic Response to Coronavirus Disease 2019 (COVID-19): Initial Assessment Report FEMA Operations
January through September 2020, January 2021, p. 5, https://www.fema.gov/sites/default/files/documents/fema_covid-
19-initial-assessment -report_2021.pdf.
83 Authorized in Stafford Act Sections 402, 403, 418, 419, and 502; 42 U.S.C. §§5170a, 5170b, 5185, 5186, and 5192.
See also 44 C.F.R. §206.208.
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eligible for PA on behalf of the requesting Applicants. According to FEMA, the agency exercised
this authority to procure and distribute testing supplies and services directly to states, tribes,
territories, local governments, and eligible nonprofits during the early phase of the federal
pandemic response.84
Beginning in early May 2020, FEMA announced that the agency would begin delivering a limited
amount of testing materials to states, tribes, and territories to support each government’s own
testing plan, in accordance with the Trump Administration’s Testing Blueprint.85 FEMA
Administrator Peter Gaynor explained that each government would begin receiving testing swabs
and transport media from FEMA by May 14, 2020, and would continue to receive weekly
distributions through the end of June 2020.86 In June 2020, FEMA reported that the agency
planned to conclude its testing supply procurement and distribution operation in early July
2020.87 FEMA confirmed this timeline in April 2021.88
These activities were provided as a form of Direct Federal Assistance authorized under the
Stafford Act, and also through authorities established in an interagency agreement with ASPR of
HHS.89 States, tribes, and territories were responsible for determining a distribution strategy to
meet the needs of their own populations.90 While supplies purchased through FEMA’s
interagency agreement with ASPR were free to applicants, supplies provided as Direct Federal
Assistance were initial y subject to a 25% nonfederal cost share.91 However, President Biden has
subsequently waived the cost share for testing supplies purchased or supplied directly to
applicants between January 20, 2020 and September 30, 2021.92
Some nonfederal stakeholders praised FEMA’s testing supply distribution effort.93 However,
some Members of Congress and nonfederal stakeholders raised concerns related to FEMA’s
procurement and distribution of testing supplies, following reports that some distributed supplies

84 Email from FEMA Office of Congressional and Legislative Affairs to CRS, June 19, 2020.
85 FEMA, “Federal Support to Expand National T esting Capabilities”; HHS, “COVID-19 Strategic T esting Plan,” pp.
20-21.
86 T estimony of FEMA Administrator Peter Gaynor and Rear Admiral John Polowczyk, in U.S. Congress, Senate
Homeland Security and Governmental Affairs Committee, Evaluating the Federal Governm ent’s Procurem ent and
Distribution Strategies in Response to the COVID-19 Pandem ic, hearing, 116th Cong., 2nd sess., June 9, 2020, p. 11, at
https://www.hsgac.senate.gov/imo/media/doc/T estimony-Gaynor%20&%20Polowczyk-2020-06-09.pdf.
87 FEMA Office of Congressional and Legislative Affairs email to CRS, June 23, 2020.
88 FEMA Office of Congressional and Legislative Affairs email to CRS, April 16, 2021.
89 FEMA and HHS, “Memorandum of Understanding Between the Federal Emergency Management Agency and the
Department of Health and Human Services, Office of Assistance Secretary of Preparedness Response,” executed April
5, 2020, provided to CRS by FEMA Office of Congressional and Legislative Affairs; FEMA, “ Coronavirus Pandemic
Response: Summary of Cost Share by Shared Resources,” September 17, 2020, https://www2.illinois.gov/iema/
LocalEMA/Documents/PAforms/COVID-19-CostShare.pdf.
90 FEMA, “Federal Support to Expand National T esting Capabilities.”
91 FEMA, “Coronavirus Pandemic Response: Summary of Cost Share by Shared Resources,” September 17, 2020,
available at https://www2.illinois.gov/iema/LocalEMA/Documents/PAforms/COVID-19-CostShare.pdf.
92 FEMA, “FEMA Statement on 100% Cost Share,” February 3, 2021, https://www.fema.gov/press-release/20210203/
fema-statement-100-cost-share.
93 See, for example, Director, Office of Emergency Services, Governor’s Office of California Ghilar ducci, who testified
that “this is a huge one-time increase in rapid point -of-care testing for the State and will be immensely helpful.” U.S.
Congress, House Subcommittee on Oversight, Management, and Accountability and House Subcommittee on
Emergency Preparedness, Response, and Recovery, Reviewing Federal and State Pandem ic Supply Preparedness and
Response, 116th Cong,. 2nd sess., July 14, 2020, No. 116-76, p. 18.
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were faulty and that agency efforts did not resolve testing supply gaps.94 GAO has issued several
recommendations relevant to FEMA’s distribution of testing supplies, including the following:
 HHS, in coordination with FEMA, develop and communicate to stakeholders
plans outlining specific federal government actions that wil be taken to help
mitigate medical supply gaps for the remainder of the pandemic.95
 HHS, in coordination with FEMA, document roles and responsibilities for supply
chain management functions that were transitioning to HHS.96
 HHS, in coordination with FEMA, devise solutions to help states, tribes,
territories, and local governments track supply requests.97
FEMA and HHS initial y disagreed with these recommendations from GAO, noting their ongoing
work to manage the medical supply chain.98 The recommendations remain open as of March
2021.99
Delivery of Testing for COVID-19
This set of questions addresses issues related to individuals accessing testing, including (1) who
can receive testing, (2) the settings where testing is available, and (3) the settings where testing is
available for individuals who are unable to pay for the full costs of testing.
What Is CDC’s Role in Setting Testing Guidelines?
States and other jurisdictions (e.g., tribal, territorial) are primarily responsible for setting
prioritization criteria and other jurisdiction-specific policies for COVID-19 testing. At an
individual level, testing recommendations may rely on clinician judgement.100 State approaches
may differ depending on their respective testing capacities and the level of COVID-19
transmission in their communities.101 The federal government, particularly through CDC, can

94 Ibid. See also, for example Chairman James E. Clyburn, Chairman, Select Subcommittee on th e Coronavirus Crisis,
et al., Letter to Department of Homeland Security Secretary Mayorkas and FEMA Acting Administrator Robert Fenton,
March 30, 2021, pp. 1, 10-11, https://coronavirus.house.gov/sites/democrats.coronavirus.house.gov/files/2021-03-
30.Select%20Sub%20to%20Mayorkas%20Fenton%20re%20DHS%20FEMA%20.pdf ; Senators Elizabeth Warren,
T ina Smith, et al., Letter to Vice President Pence, April 10, 2020, https://www.warren.senate.gov/imo/media/doc/
LT O.20-04-09.Diagnostic%20Testing%20Inventory.pdf; and Ryan Gabrielson and J. David McSwane, “ FEMA
Ordered $10.2 Million in COVID-19 T esting Kits It’s Now Warning States Not to Use,” ProPublica, June 26, 2020,
https://www.propublica.org/article/fema-ordered-10-2-million-in-covid-19-testing-kits-its-now-warning-states-not-to-
use.
95 T his recommendation, first issued in GAO, COVID-19: Federal Efforts Could Be Strengthened by Timely and
Concerted Actions, GAO-20-701, September 2020 (hereinafter GAO, COVID-19: Federal Efforts), p. 1,
https://www.gao.gov/products/gao-20-701, was reiterated in GAO, COVID-19: Sustained Federal Action is Crucial as
Pandem ic Enters Its Second Year, GAO-21-387, pp. 80, 88, 177-178, 455-56 (hereinafter GAO, COVID-19: Sustained
Federal Action), https://www.gao.gov/assets/gao-21-387.pdf.
96 T his recommendation, first issued in GAO’s September 2020 report, GAO, COVID-19: Federal Efforts, p. 1, was
reiterated in GAO, COVID-19: Sustained Federal Action, pp. 80, 177-178, and 455-56.
97 Ibid.
98 GAO, COVID-19: Sustained Federal Action, pp. 177-178.
99 GAO, COVID-19: Sustained Federal Action, pp. 455-456.
100 CDC, “T esting for COVID-19,” last updated June 24, 2020, https://www.cdc.gov/coronavirus/2019-ncov/
symptoms-testing/testing.html.
101 Bill McBride, Memorandum: Capacity for COVID-19 Testing- Current Status, National Governors Association,
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inform these criteria by issuing guidance. As the federal government’s lead public health agency,
CDC develops and maintains expertise on the science and best practices for testing as a part of
public health responses and ongoing disease mitigation.102
These guidance documents are general y advisory in nature, unless specifical y promulgated by
regulation or executive order.103 CDC has general y opted to inform clinical practice through
guidance, rather than regulation. While these advisory guidelines are not binding, they can serve
to establish best practices in a given field.104 These best practices can have broad implications for
a variety of entities, including local jurisdictions and medical licensing agencies. A local
jurisdiction may consider a nonbinding CDC issued guidance a new threshold that must be met
for achieving best practices, whereas a medical licensing agency may consider the same guidance
as evidence for the standard of practice against which licensees should be measured.
CDC has issued a number of guidance documents throughout the COVID-19 pandemic related to
testing practices that have evolved with testing supply, availability of different test types, testing
priorities, and levels of disease transmission in different locations and communities, among other
factors. Early testing guidance focused on how to prioritize the use of limited testing supply (see
next question). As the pandemic has evolved, various guidance documents have provided
standards and technical assistance for state and local health departments in a variety of situations,
for example, testing individuals at homeless service provider sites or how and when health care
providers, laboratories, and public health staff should use antibody tests.105 CDC has also recently
updated testing guidance for students, teachers, and staff in K-12 education settings.106 CDC has
additional y issued further guidance on expanded availability and use of screening tests and
information on testing vaccinated individuals.107 These guidance documents are often updated or
replaced as new information is found, which then can trigger the downstream c hange in standard
of practice mentioned previously.
At times, changes in CDC guidelines have caused confusion, and in some cases, observers have
raised concerns about their scientific validity.108 In addition, frequent changes to published
guidance can impose an additional burden on state and local entities that may adjust operations to
meet the new standard established by the guidance. A November 2020 GAO report evaluated

May 14, 2020, https://www.nga.org/wp-content/uploads/2020/04/T esting-Memo-Update-5-13-20.pdf.
102 CDC, “CDC in Action: Working 24/7 to Stop the T hreat of COVID-19,” February 4, 2021, https://www.cdc.gov/
budget/documents/covid-19/CDC-247-Response-to-COVID-19-fact-sheet.pdf.
103 For a further detailed discussion on how guidance documents may affect policy, see CRS Report R44468, General
Policy Statem ents: Legal Overview, by Jared P. Cole and T odd Garvey.
104 See, for example, CDC, “About the CDC Guidelines for Infection Control in Dental Health Care -2003,” updated
November 26, 2019, https://www.cdc.gov/oralhealth/infectioncontrol/faqs/about-the-cdc-guidelines.html (stating that
“CDC develops guidelines and recommendations to improve the effectiveness and impact of public health interventions
and inform key audiences, such as clinicians, public healt h practitioners, and the public”).
105 CDC, “Guidance for COVID-19,” https://www.cdc.gov/coronavirus/2019-ncov/communication/guidance-list.html?
Sort=Date%3A%3Aasc&T opic=Disease%20Information%20%3E%20Testing.
106 CDC, “Guidance for COVID-19,” https://www.cdc.gov/coronavirus/2019-ncov/communication/guidance-list.html?
Sort=Date%3A%3Aasc&T opic=Disease%20Information%20%3E%20Testing.
107 CDC, “T esting Overview,” https://www.cdc.gov/coronavirus/2019-ncov/hcp/testing-overview.html#previous.
108 See, for example, Apoorva Mandavilli, “ C.D.C. T esting Guidance Was Published Against Scientists’ Objections,”
New York Tim es, November 19, 2020; Carl O'Donnell, Vishwadha Ch ander, and Manojna Maddipatla, “ Exclusive:
Most U.S. States Reject T rump Administration’s New COVID-19 T esting Guidance,” Reuters, August 28, 2020; and
National Academy of Sciences and National Academy of Medicine, “ NAS and NAM Presidents Alarmed By Political
Interference in Science Amid Pandemic,” press release, September 24, 2020, https://www.nationalacademies.org/news/
2020/09/nas-and-nam-presidents-alarmed-by-political-interference-in-science-amid-pandemic.
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issues around CDC’s testing guideline. GAO noted confusion and misunderstandings around the
guidelines for rapid antigen testing, and lack of coordination around guidelines and requirements
for such tests from FDA, CMS, and CDC. GAO also noted that CDC testing guideline changes
were not always transparently communicated and recommended that the CDC clearly disclose the
scientific rationale for any change to the testing guidelines at the time the changes are made.109
How Has Testing Been Prioritized?
As the pandemic has evolved, CDC has issued guidance to identify populations prioritized for
various types of tests. In the early stages of the pandemic, CDC guidance recommended limiting
COVID-19 diagnostic testing mostly to individuals with relevant travel or exposure history, as a
means of conserving limited testing supply.110 As of March 17, 2021, CDC guidance includes
considerations for the uses of diagnostic and serologic testing, testing symptomatic and
asymptomatic individuals, and the testing of vaccinated individuals. In previous iterations, CDC
had recommended that diagnostic tests be prioritized for the following four populations:
 individuals with signs or symptoms consistent with COVID-19;
 asymptomatic individuals with recent known or suspected exposure to SARS-
CoV-2 to control transmission;
 asymptomatic individuals without known or suspected exposure to SARS-CoV-2
for early identification in special settings (e.g., congregate living settings); and
 individuals being tested for purposes of public health surveil ance for SARS-
CoV-2.111
As testing supply has increased, CDC has begun issuing broad guidance documents for COVID-
19 testing in a variety of populations, including non-health care workplaces, schools, and other
congregate settings.112 The latest iterations of CDC testing guidance (i.e., March 17, 2021
guidance) reflect a greater focus on equity considerations in both urban and rural areas, such as
testing access and availability.113 CDC has also developed more specific guidance related to
testing certain populations or testing programs in specific settings.114
Where Can Individuals Get a COVID-19 Test?
Testing availability may vary by state and by the type of test sought. General y, a range of both
ambulatory and inpatient health care settings and providers (e.g., hospitals, doctors’ offices,
urgent care centers) provide testing, and some congregate living sites (e.g., nursing homes) may
provide testing to their residents. In addition, many jurisdictions have established testing

109 U.S. Government Accountability Office, COVID-19: Urgent Actions Needed to Better Ensure an Effective Federal
Response, GAO-21-191, November 2020, p. 84-85, https://www.gao.gov/assets/gao-21-191.pdf.
110 CRS Report R46219, Overview of U.S. Domestic Response to Coronavirus Disease 2019 (COVID-19).
111 CDC, “Coronavirus Disease 2019 (COVID-19): T esting Overview,” Updated July 2, 2020, https://www.cdc.gov/
coronavirus/2019-ncov/hcp/testing-overview.html?CDC_AA_refVal=
https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019 -ncov%2Fhcp%2Fclinical-criteria.html.
112 CDC, “Guidance for COVID-19,” https://www.cdc.gov/coronavirus/2019-ncov/communication/guidance-list.html?
Sort=Date%3A%3Aasc&T opic=Disease%20Information%20%3E%20Testing.
113 CDC, “T esting Overview,” https://www.cdc.gov/coronavirus/2019-ncov/hcp/testing-overview.html#previous.
114 For example, CDC has issued testing guidelines for nursing homes: https://www.cdc.gov/coronavirus/2019-ncov/
hcp/nursing-homes-testing.html, and for high-density critical infrastructure workplaces: https://www.cdc.gov/
coronavirus/2019-ncov/community/worker-safety-support/hd-testing.html.
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programs in community-based settings, such as walk-up or drive-through testing sites, public
health departments, and those at retail pharmacies. A number of settings provide free or reduced-
cost tests to the general population using another source of payment (see the “Where Are Free or
Reduced Cost Tests Available?” section of this report).
General y, state law governs who may order a test, which in turn may affect the settings where
testing is available. For example, not al states permit nurse practitioners to order tests, so in those
states a person would need to see a physician to have a test ordered.115 Some states have
expanded the roles of health professionals during the period of the state’s emergency declaration.
In some cases, this expanded authority is to expire at the end of the state declared emergency.
Given this, who may order a test may change over time.116 Two factors inform whether a
complete test is available directly from a provider or if a central laboratory must be involved in its
processing: (1) the settings that are able to provide tests (e.g., whether testing is available at a
pharmacy), which may be affected by both state law and CLIA (Clinical Laboratory Improvement
Amendments of 1988) requirements and (2) where a test is FDA-authorized to be provided (e.g.,
a waived or point-of-care setting). Test availability may also differ based on the locations where a
given payor may pay for testing. For example, some payors may require the provider to be
recognized as meeting federal (and sometimes state) conditions of participation requirements
(e.g., Medicaid participating provider) in order to pay for a test that a program enrollee receives
from that provider.
Where Are Free or Reduced Cost Tests Available?
A number of types of health care and other settings may administer COVID-19 tests; however,
few types of facilities have requirements to provide care to al individuals regardless of their
ability to pay. As such, not al testing sites provide free testing nor do al types of facilities test
uninsured individuals.
Public Health Department Testing Programs
Throughout the pandemic, state, local, territorial, and tribal (SLTT) health departments have
operated diagnostic testing programs, though activities have varied by jurisdiction. For example,
some local health departments have operated temporary testing sites (e.g., drive-through testing
sites), or so-cal ed “mobile strike teams,” to provide targeted testing in outbreak areas or for
certain populations, such as uninsured or high-risk individuals.117 Some of the community-based
testing sites have been operated jointly by FEMA and/or HHS with health departments, while
others have been operated in partnership with health care provider organizations or commercial
partners such as retail pharmacies (e.g., CVS).118 In the early stages of the pandemic, many of the

115 National Alliance of State Pharmacy Associations, “COVID-19 T esting,” https://naspa.us/resource/covid-19-testing/
. On April 8, 2020, HHS released guidance authorizing pharmacists to order te sting and providing immunity to do so.
See HHS, “Guidance for Licensed Pharmacists, COVID-19 T esting, and Immunity under the PREP Act,”
https://www.hhs.gov/sites/default/files/authorizing-licensed-pharmacists-to-order-and-administer-covid-19-tests.pdf.
116 For state provider licensure changes during the COVID-19 emergency period, see Federation of State Medical
Boards, U.S. States Modifying Requirem ents for Telehealth in Response to COVID-19, March 6, 2021,
https://www.fsmb.org/siteassets/advocacy/pdf/states-waiving-licensure-requirements-for-telehealth-in-response-to-
covid-19.pdf.
117 National Association of City and County Health Officials (NACCHO), Local Health Departments Standing Strong
on the Frontlines of COVID-19 Response, April 9, 2020, https://www.naccho.org/uploads/downloadable-resources/
Press-Release-NPHW-2020-Role-of-LHDs-in-COVID-19-Response_4.9.20.pdf.
118 Bill McBride, Memorandum: Capacity for COVID-19 Testing- Current Status, National Governors Association,
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health department testing programs were focused on target populations, such as health care
workers and first responders.119 Some health department testing programs then expanded to
become more broadly available in some jurisdictions, though the availability of testing and the
populations that can access such testing has varied by jurisdiction. Moving forward, it is unclear
to what extent the public health sector wil remain responsible for ongoing diagnostic testing
programs. Traditional y, clinical diagnosis activities are largely conducted within the clinical
sector, while public health is responsible for outbreak response, surveil ance, and some efforts to
protect at-risk populations.120
Testing provided by or in partnership with health departments is often available free of charge to
individuals, though testing is often limited to residents of a certain jurisdiction and some
programs may seek to bil private health insurance plans or public payors (e.g., Medicaid) for
individuals with applicable coverage or to charge certain individuals for testing.121 CDC and other
grant funding provided through several coronavirus supplemental appropriations measures have
supported testing programs run by health departments.122 In particular, to date, over $40 bil ion
has been awarded to jurisdictions as Epidemiology and Laboratory Capacity (ELC) grants123 that
can be used to support public health department testing programs; al owable items in this funding
stream include most costs associated with standing up, operating, and demobilizing testing
sites.124 In addition, the American Rescue Plan Act of 2021 (ARPA) provided $47.8 bil ion
available until expended for testing, contact tracing, and mitigation activities related to
monitoring and reducing the spread of COVID-19.
In late 2020-early 2021, SLTT health jurisdictions focused their efforts on providing testing
opportunities in underserved areas and populations. This includes establishing testing sites,
facilitating partnerships with local leaders, and building communication networks with
populations who have limited access to testing. For example, the state of California funded over
100 testing sites in communities of color, while other jurisdictions, such as Hamilton County
Tennessee, built partnerships with the faith-based community to establish testing sites in
predominately Black communities.125

May 14, 2020, https://www.nga.org/wp-content/uploads/2020/04/T esting-Memo-Update-5-13-20.pdf.
119 Association of State and T erritorial Health Officials, 16 Key Considerations for Drive-Through or Mobile Testing,
March 19, 2020, https://astho.org/StatePublicHealth/16-Key-Considerations-for-Drive-Through-or-Mobile-Testing/03-
19-20/.
120 Association of Public Health Laboratories (APHL), “Smart T esting for Optimizing P andemic Response,” January
2021, https://www.aphl.org/aboutAPHL/publications/Documents/ID-2021-Smart-Testing-for-Optimizing-Pandemic-
Response.pdf.
121 For example, the District of Columbia (DC) operates free testing sites for DC residents who do not have individual
providers experiencing any COVID-19 symptoms or with known exposures. Although individuals with insurance will
be asked to provide their information, testing will be p rovided to residents at no cost; see https://coronavirus.dc.gov/
testing. T he T exas Department of State Health Services states “ unless otherwise stated, deductible, co-pay, or co-
insurance may apply.” Public health testing programs vary by local jurisdiction in T exas. See https://dshs.texas.gov/
coronavirus/testing.aspx.
122 GAO, COVID-19: Sustained Federal Action Is Crucial as Pandemic Enters Its Second Year, GAO-21-387, March
31, 2021, https://files.gao.gov/reports/GAO-21-387/index.html#appendix7.
123 HHS, “COVID-19 Funding ELC Enhancing Detection Expansion,” https://www.hhs.gov/sites/default/files/covid-
19-funding-elc-enhacing-detection-expansion.pdf.
124 CDC, “ELC Enhancing Detection Expansion Questions & Answers,” March 15, 2021, https://www.cdc.gov/ncezid/
dpei/pdf/elc-enhancing-detection-expansion-faq-508.pdf.
Karen DeSalvo, Bob Hughes, and Mary Bassett , Public Health COVID-19 Im pact Assessm ent: Lessons Learned and
Com pelling Needs. National Academy of Medicine. April 7, 2021. https://nam.edu/public-health-covid-19-impact-
assessment -lessons-learned-and-compelling-needs/.
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As local health departments have taken on a significant role in distributing and administering
COVID-19 vaccines to their communities, testing remains a core function of preventing the
spread of COVID-19. While distinct appropriations from recent COVID-19 relief acts have been
made for both vaccine and testing capabilities, local health jurisdictions may have limited
capacity in terms of public health workforce for al functions of the COVID-19 response.126
Another area of concern is that most local health jurisdiction surge staff were hired on as
temporary, term-limited contract workers, which may lead to a decrease in staffing at the end of
the fiscal year. Until funding streams are fully implemented and SLTT health jurisdictions are
able to hire appropriate staff, jurisdictions may need to divert staff and resources from testing
initiatives in order to meet vaccination demand and goals.
It is difficult to predict how long such expanded testing and contact tracing efforts within the
public health sector wil last. The CDC recommends surging testing and contact tracing capacity
as the number of cases in a jurisdiction rises.127 Continued testing may be required to monitor
community spread of COVID-19, even with ongoing vaccinations. As more individuals are
vaccinated, experts expect the severity and prevalence of disease to decrease, but are aware that
community transmission of COVID-19 may stil occur. Additional federal awards made with
funding from ARPA may facilitate increasing the capacity of public health infrastructure to
maintain a consistent level of testing, even when community transmission is relatively low due to
increased vaccination.128
Moving forward, public health departments and laboratories may focus their efforts on
surveil ance and screening testing, instead of clinical diagnostic testing. Public health surveil ance
testing gathers and monitors population or community level data on disease outbreaks, which
al ows health jurisdictions to characterize disease incidence and prevalence.129 Public health
departments also play a significant role in the Biden Administration’s efforts to establish
screening testing programs in schools and other settings.130
Emergency Departments
Hospitals with emergency departments are required to provide an appropriate medical screening
examination and stabilization care regardless of a patient’s eligibility to participate in Medicare.
This obligation is required under the Emergency Medical Treatment and Active Labor Act
(EMTALA),131 and it general y extends to individuals who come to the emergency department
and are suspected to have COVID-19.132 EMTALA does permit hospitals to bil individuals for

126 See, for example, a discussion on how the Biden Administration is prioritizing bolstering the public health
workforce. Steven Findlay, As Pandem ic Surged, Contact Tracing Struggled; Biden Looks to Boost It, Kaiser Health
News, February 10, 2021, https://khn.org/news/article/as-pandemic-surged-contact -tracing-struggled-biden-looks-to-
boost -it/.
127 CDC, “Prioritizing Case Investigations and Contact T racing for COVID-19 in High Burden Jurisdiction,”
https://www.cdc.gov/coronavirus/2019-ncov/php/contact-tracing/contact-tracing-plan/prioritization.html
128 P.L. 117-2 Section 2401.
129 CDC, “T esting Strategies for SARS-CoV-2,” updated May 27, 2021, https://www.cdc.gov/coronavirus/2019-ncov/
lab/resources/sars-cov2-testing-strategies.html. See “ Public Health Surveillance T esting”
130 HHS, “ Biden Administration to Invest More Than $12 Billion to Expand COVID-19 T esting,” press release, March
17, 2021, https://www.hhs.gov/about/news/2021/03/17/biden-administration-invest-more-than-12-billion-expand-
covid-19-testing.html.
131 42 U.S.C. §1395dd.
132 HHS, Center for Medicare and Medicaid Services (CMS), “Emergency Medical T reatment and Labor Act
(EMT ALA) Requirements and Implications Related to Coronavirus Disease 2019 (COVID -19),” memorandum, March
9, 2020, at https://www.cms.gov/files/document/qso-20-15-emtala-requirements-and-coronavirus-0311-updated-
003pdf.pdf-1.
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services provided pursuant to their EMTALA obligation. Although some individuals may pay for
these services, hospitals that provide care pursuant to their EMTALA obligation may seek
payment from the uninsured testing fund discussed below. As mentioned above, some
community-based and facility-specific testing may be available to individuals who do not have a
source of payment. In addition, the federal government has created an uninsured fund to
reimburse facilities for testing provided to uninsured individuals. Congress has enacted legislation
that has expanded Medicaid eligibility so that Medicaid funds may be available for testing for
some individuals who are otherwise ineligible for Medicaid (see the “How Can Facilities That
Provide Testing for Uninsured Individuals Be Reimbursed?” section of this report).
Health Centers
Federal health centers (also cal ed federal y qualified health centers or FQHCs) are outpatient
facilities that receive federal grants to provide primary care and other services. They must be
located in medical y underserved areas and provide care to al individuals regardless of their
ability to pay. They may bil patients with public or private insurance coverage for the services
provided, and they are required to use a sliding scale fee schedule for individuals who do not have
coverage.133 Health centers have received more than $9.6 bil ion in supplemental funding to
provide COVID-19 testing and related care. Of that amount, $600 mil ion was explicitly
appropriated for testing in PPHCEA; however, al of the funds appropriated to health centers were
to prevent, prepare for, and respond to COVID-19, which includes testing.134 The Health
Resources and Services Administration (HRSA), which administers the health center program,
surveyed health centers on the impact of COVID-19 on their operations. The survey found that
more than 90% of responding health centers were offering testing, in some states nearly al health
centers offered walk-up or drive up testing, though the availability varied by state and territory.135
Federally Qualified Health Center Look-Alikes
Federal y Qualified Health Center Look-Alikes (cal ed Look-Alikes) are outpatient centers
similar to the health centers described above, but Look-Alikes do not receive a health center
grant. Like health centers, these entities serve an underserved population, must be located in
medical y underserved areas, and are required to provide care to al individuals regardless of their
ability to pay. As such, Look-Alikes are a setting where uninsured individuals may receive
COVID-19 testing. The majority (93.3%) of Look-Alikes reported to HRSA that they have
COVID-19 testing capacity, with nearly two-thirds providing walk-up or drive-up testing.136
Look-alikes were eligible to receive funds appropriated for testing in PPPHCEA and were eligible
to receive funds under the $7.6 bil ion appropriated for health centers and community care in
ARPA.P.L. 117-2). ARPA funds were made available for a number of COVID-19 preparation and
response activities, which includes testing. In addition, these funds may be used for expenses that
were incurred since the beginning of the PHE. Specific uses of these funds by look-alikes is not
known.

133 CRS Report R43937, Federal Health Centers: An Overview.
134 CRS Insight IN11367, Federal Health Centers and COVID-19; CRS Report R46711, U.S. Public Health Service:
COVID-19 Supplem ental Appropriations in the 116th Congress; and Section 2601 of P.L. 117-2.
135 HHS, Health Resources and Services Administration (HRSA), “Health Center Covid-19 Survey: Operational
Capacity” https://data.hrsa.gov/topics/health-centers/covid-operational-capacity, accessed March 26, 2021.
136 HHS, HRSA, “Health Center Program Look-Alike COVID-19 Survey National Summary Report,” latest data from
April 2, 2021.
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Federal Community-Based Testing Sites
During the initial months of FEMA’s coordination of pandemic response efforts, FEMA
collaborated with HHS to establish and staff community-based testing sites (CBTS) in partnership
with state and local governments.137 In March 2020, FEMA and HHS helped establish 41 CBTS
throughout the country.138 Initial y, local staff at each site were supplemented by one federal
physician and by U.S. Public Health Service personnel.139 The federal government also provided
assistance with contracts, logistics, lab processing, and patient notification. The sites initial y
focused on testing for certain health care facility workers and first responders, though later they
expanded access to a broader population.140
In early April 2020, FEMA announced the option for CBTS to transition to full state
management, with states assuming responsibilities such as staffing, procurement, and testing.141
These sites continued to receive direct assistance (e.g., supplies) and reimbursement for eligible
costs (e.g., staff overtime, testing supplies) through the FEMA Public Assistance Program. In late
June 2020, FEMA reported to CRS that most community-based testing sites had closed or
transitioned to state management. The 13 remaining federal y run sites were due to close or
transition to full state management by June 30, 2020, though sites would remain eligible for
financial support and supplies through the Public Assistance program.142 Subsequently, several
sites in Texas continued to receive federal operational support in response to requests by the
Office of the Governor.143
In May 2020, FEMA announced that the federal government, led by HHS, would build upon the
first publicly run CBTS model to expand testing nationwide through a public-private
partnership.144 Under CBTS 2.0, or the “community-based sites public-private partnership,” the
federal government provided a flat fee for each test administered by pharmacy and retail
companies at hundreds of sites throughout the country.145 According to the GAO, participants

137 GAO, COVID-19: Opportunities to Improve Federal Response and Recovery Efforts, June 2020, GAO-20-625, p.
91 (hereinafter GAO, COVID-19: Opportunities), https://www.gao.gov/assets/gao-20-625.pdf.
138 FEMA, “Weekly Update: Coronavirus Pandemic Whole-of-America Response,” June 18, 2020, p. 2, provided by
FEMA Congressional and Legislative Affairs. FEMA, “Coronavirus (COVID-19) Pandemic Whole-of-Government
Response,” Wednesday, March 25, 2020, p. 3; FEMA, “Option to Transition Federal Community -Based T esting Sites
to State Management,” advisory, April 9, 2020, (hereinafter FEMA, “Community-Based T esting Sites”),
https://www.fema.gov/news-release/20200726/option-transition-federal-community-based-testing-sites-state-
management .
139 HHS, “COVID-19 Strategic T esting Plan,” p. 24.
140 FEMA, “Community-Based T esting Sites.”
141 Ibid.
142 A FEMA Office of Congressional and Legislative Affairs email to CRS, June 23, 2020, noted that all sites were due
to close or transition by June 30, 2020. FEMA guidance indicated that community -based testing sites under state
management continued to remain eligible for Public Assistance. FEMA, “Community -Based T esting Sites.”
143 HHS, “Assistant Secretary for Health Admiral Brett P. Giroir, M.D., Statement on T exas Community -Based T esting
Sites 1.0 Extension,” June 26, 2020, https://www.hhs.gov/about/news/2020/06/26/assistant-secretary-for-health-
admiral-brett -p-giroir-md-statement-on-texas-community-based-testing-sites-1-0-extension.html; Office of T exas
Governor, “Governor Abbott Announces Additional Extension Of Community Based COVID-19 T esting Sites In
Houston, Harris County,” December 30, 2020, https://gov.texas.gov/news/post/governor-abbott-announces-additional-
extension-of-community-based-covid-19-testing-sites-in-houston-harris-county.
144 FEMA, “Federal Support to Expand National T esting Capabilities”; T estimony of the Office of the Assistant
Secretary for Health, U.S. Congress, Senate Committee on Health, Education, Labor, and Pensions, COVID-19: An
Update on the Federal Response, 116th Cong., 2nd sess., Sept. 23, 2020 (hereinafter COVID-19: Updated Federal
Response), https://www.cdc.gov/washington/testimony/2020/t20200923.htm.
145 FEMA, “Federal Support to Expand National T esting Cap abilities”; HHS, “COVID-19 Strategic T esting Plan,” pp.
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(i.e., pharmacies and retail companies) could submit claims to cover expenses after federal
payments end to private insurers, Medicare, Medicaid, and the COVID-19 Uninsured Program
(the program is ongoing as of August 2021).146 HHS reported that the private sector partners are
responsible for coordinating the full testing process, including registration, scheduling, provider
order, patient notifications, medical supplies, equipment, and lab testing.147
In January 2021, HHS reported that 3,300 sites established through the public-private partnership
were operating in 50 states, Washington, DC, and Puerto Rico, and had processed more than 5.6
mil ion samples since the program’s initiation.148 HHS reported that the majority of the sites were
located in areas with “moderate to high social vulnerability.”149 The HHS-operated Community
Based Testing Sites website lists retail partners by state.150 HHS further announced that the
partnership would continue to operate through April 2021, as a result of a $550 mil ion funding
extension.151
Concerns from some Members of Congress, federal officials, and nonfederal stakeholders
regarding the community-based sites’ public-private partnership, include the following:
 how sites were selected and the duration of federal site management, particularly
amid concerns over insufficient numbers of sites and premature cessation of
federal support for testing sites;152
 the closure of testing sites damaged during episodes of civil unrest;153

24-25; HHS, “ HHS Extends COVID-19 T esting Public-Private Partnership,” June 30, 2020, https://www.hhs.gov/
about/news/2020/06/30/hhs-extends-covid-19-testing-public-private-partnership.html.
146 GAO, COVID-19: Federal Efforts, p. 27, note 56. See also T estimony of the Office of the Assistant Secretary for
Health, COVID-19: Updated Federal Response.
147 HHS, “HHS Extends COVID-19 T esting Public-Private Partnership,” June 30, 2020, https://www.hhs.gov/about/
news/2020/06/30/hhs-extends-covid-19-testing-public-private-partnership.html.
148 HHS, “HHS Continues Community Based T esting Sites for COVID-19,” release, January 7, 2021,
https://www.hhs.gov/about/news/2021/01/07/hhs-continues-community-based-testing-sites-covid-19.html.
149 Ibid. and HHS, “COVID-19 Strategic T esting Plan,” p. 25. Submitted testimony of HHS Assistant Secretary for
Health Brett Giroir, Evaluating the Federal Governm ent’s Procurem ent and Distribution Strategies in Response to the
COVID-19 Pandem ic, hearings, 116th Cong., 2nd sess., June 9, 2020, p. 7, https://www.hsgac.senate.gov/evaluating-the-
federal-governments-procurement-and-distribution-strategies-in-response-to-the-covid-19-pandemic. “ Moderate to
high social vulnerability” is defined according to CDC’s Social Vulnerability Index. See CDC/AT SDR, “ CDC/AT SDR
Social Vulnerability Index,” April 28, 2021, https://www.atsdr.cdc.gov/placeandhealth/svi/index.html. For related
discussion, see Garth Graham, “ Addressing the Disproportionate Impact of COVID-19 on Communities of Color,”
Journal of Racial and Ethnic Health Disparities, vol. 8, no. 2 (2021), pp. 280-282.
150 HHS, “Community-Based T esting Sites for COVID-19,” https://www.hhs.gov/coronavirus/community-based-
testing-sites/index.html.
151 HHS, “HHS Continues Community Based T esting Sites for COVID-19,” release, January 7, 2021,
https://www.hhs.gov/about/news/2021/01/07/hhs-continues-community-based-testing-sites-covid-19.html.
152 See statement of Rep. Sheila Jackson Lee, U.S. Congress, House Committee on Homeland Security, Examining the
National Response to the Worsening Coronavirus Pandem ic: Part II, 116th Cong., 2nd sess., July 22, 2020, pp. 22-23,
https://media.proquest.com/cdn/media/hms/PFT /1/aYXeI?_tm=1618328042836&_cfs=
eX1rlF3bzplI58zyDehVFVRPShXsQnFz0oQ5GLsXpNk%3D; Jessica Boehm, “ Phoenix Mayor Kate Gallego says
federal government denied requests for COVID-19 testing help,” Arizona Republic, July 6, 2020,
https://www.azcentral.com/story/news/local/phoenix/2020/07/06/phoenix-mayor-gallego-fema-denied-coronavirus-
testing/3286326001/; Statements by Rep. Andy Kim, U.S. Congress, House Select Subcommittee on the Coronavirus
Crisis, Committee on Oversight and Reform, The Adm inistration’s Efforts to Procure, Stockpile, and Distribute,
hearing, 116th Cong., 2nd sess., July 2, 2020, No. 116-101, p. 35.
153 Amy Goldstein, “Scores of testing sites forced to close because of vandalism in civil unrest,” Washington Post, June
3, 2020, https://www.washingtonpost.com/health/scores-of-testing-sites-forced-to-close-because-of-vandalism-in-civil-
unrest/2020/06/03/e6d9fa54-a4e6-11ea-b473-04905b1af82b_story.html.
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 lack of availability of tests for young children at participating sites;154
 insufficient testing access among people of color;155
 the smal scale of the community-based testing sites models relative to testing
demands;156
 difficulties encountered by independent pharmacies seeking to participate in the
public-private partnership;157 and
 insufficient clarity regarding payment for testing by third-party payers, the
federal government, or other entities. 158
Can COVID-19 Testing Be Done at Home?
There has been significant interest in, and some confusion around, at-home testing for COVID-
19. Testing at home has benefits—including increased access to testing and decreased use of PPE
and decreased risk of il ness transmission because of the ability to avoid going in person to a
health care facility—however, this type of testing requires more rigorous FDA oversight to ensure
that the lay user conducting the test can do so safely and with accurate results. Although this type
of testing has traditional y been termed “at-home” by the FDA, this type of test may actual y be
carried out in any non-laboratory setting, including and especial y relevant for COVID-19,
schools, daycares, workplaces, or high-risk settings. The “at-home” designation means that the
test may be conducted outside of a CLIA-regulated environment, and FDA has termed these tests
“non-laboratory” tests.159
Testing for COVID-19 in a home environment can involve either (1) a sample being self-
collected at home using a kit and sent to a central laboratory for processing, or (2) a complete test,
including sampling, testing, and interpretation, being conducted in the home. Complete home
testing may involve telehealth visits with a health care provider to supervise the sample collection

154 See letters to participating retailers from Senators Elizabeth Warren and T ina Smith, October 7, 2020,
https://www.warren.senate.gov/newsroom/press-releases/warren-smith-question-top-retail-testing-providers-
companies-on-lack-of-pediatric-testing-at-their-covid-19-testing-sites; Senators Elizabeth Warren and T ina Smith,
Letter to then HHS Secretary Alex M. Azar, December 7, 2020, https://www.warren.senate.gov/imo/media/doc/
2020.12.07%20Letter%20to%20HHS%20re%20testing%20investigations_updated1.pdf.
155 Ibid. U.S. Congress, House Select Subcommittee on the Coronavirus Crisis of the Committee on Oversight and
Reform, The Urgent Need for a National Plan to Contain the Coronavirus, hearing, 116th Cong., 2nd sess., July 31,
2020, No. 116-109, pp. 57-59.
156 Kate Sheridan, “T his T iny T exas Company is Running Most of the Drive-T hru COVID-19 T esting in the U.S.,”
August 3, 2020, https://www.statnews.com/2020/08/03/etruenorth-tiny-company-running-covid-19-company/; S.
Lawrence Kocot, “Expand COVID-19 T esting With Real-T ime Processing T hrough Community Pharmacies,” Health
Affairs, July 1, 2020, https://www.healthaffairs.org/do/10.1377/hblog20200629.567658//; Statement of Rep. Jackson
Lee, U.S. Congress, House Committee on Homeland Security, Exam ining the National Response to the Worsening
Coronavirus Pandem ic, 116th Cong., 2nd sess., July 8, 2020, No. 116-73, p. 8.
157 Letter from Karry K. La Violette, National Community Pharmacists Association, to Senators Warren and Smith,
October 20, 2020, p. 4, https://www.warren.senate.gov/imo/media/doc/
2020.12.07%20Letter%20to%20HHS%20re%20testing%20investigations_updated1.pdf ; S. Lawrence Kocot, “ Expand
COVID-19 T esting With Real-T ime Processing T hrough Community Pharmacies,” Health Affairs, July 1, 2020,
https://www.healthaffairs.org/do/10.1377/hblog20200629.567658//.
158 Senators Elizabeth Warren and T ina Smith, Letter to then HHS Secretary Alex M. Azar, December 7, 2020, pp. 3
and 5, https://www.warren.senate.gov/imo/media/doc/
2020.12.07%20Letter%20to%20HHS%20re%20testing%20investigations_updated1.pdf .
159 FDA, “COVID-19 T est Settings: FAQs on T esting for SARS-CoV-2,” https://www.fda.gov/medical-devices/
coronavirus-covid-19-and-medical-devices/covid-19-test-settings-faqs-testing-sars-cov-2.
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and help interpret the test result and develop a treatment plan, if indicated. Complete at-home
testing general y requires a prescription or order from a health care provider, although the FDA
does also al ow at-home tests to be offered over-the-counter (OTC), or without a prescription.
Although test developers have been free to pursue this option, it requires additional data and
studies to determine that its use would be simple and safe, and would not result in harm to the lay
user, which may serve as a barrier for test developers seeking this type of authorization.160
Advantages to OTC at-home tests are increased access and the ability to access a test and results
entirely outside of the health care setting (with no prescription or interaction with a health care
provider necessary).
The FDA must approve or authorize for marketing al at-home COVID-19 tests, at-home sample
self-collection kits, or modifications to existing EUAs for tests to specifical y al ow for at-home
sample collection methods. To date, the agency has authorized several at-home tests, available
both by prescription and OTC, and including multiple antigen tests and a handful of molecular
diagnostic tests.161 With the authorization particularly of OTC at-home tests, and federal support
for their manufacture, these tests have become more readily available across the country.
Numerous at-home sample collection kits have also been approved and EUAs have been
modified to al ow for use of at-home sample collection.162 The agency has noted that it continues
to be open to this type of testing and encourages submission of EUAs, as long as the submission
contains accompanying data “demonstrating the ability of a lay user to collect their specimen, run
the test, and interpret their results accurately.”163 Flexibilities in the EUA process granted for
many commercial and laboratory-developed COVID-19 tests do not apply to at-home testing or
sample collection, and an EUA is required prior to clinical use or commercial distribution of these
tests in any case.164
What Disparities Have Arisen in COVID-19 Testing and What Has
the Federal Government Done to Address Them?
Access to reliable and convenient COVID-19 testing sites and resources, as wel as other
disparities in testing, have been noted as an issue throughout the pandemic response. A specific
area of concern is “testing deserts.” These are geographical locations where residents have to
travel at least 10 miles to access a test.165 According to national data on testing site locations
compiled by a health technology firm, testing deserts were disproportionately located in more

160 See for example, FDA, “Over-the-Counter Diagnostic T ests for the Detection of Pathogens Causing Infectious
Diseases,” August 2016, https://www.fda.gov/media/99903/download.
161 FDA, “In Vitro Diagnostic EUAs,” https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-
emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas.
162 See for example, FDA, “ Coronavirus (COVID-19) Update: FDA Authorizes First T est for Patient At -Home Sample
Collection,” April 21, 2020, https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-
authorizes-first-test-patient-home-sample-collection.
163 FDA, “COVID-19 T est Settings: FAQs on T esting for SARS-CoV-2,” https://www.fda.gov/medical-devices/
coronavirus-covid-19-and-medical-devices/covid-19-test-settings-faqs-testing-sars-cov-2.
164 FDA, “Policy for Coronavirus Disease-2019 T ests During the Public Health Emergency (Revised),” May 11, 2020,
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-coronavirus-disease-2019-tests-
during-public-health-emergency-revised.
165 Heath, Sara, “Patients Face Geographic Barriers to COVID-19 T esting Access,” Patient Engagement Hit: Patient
Care Access News, August 24, 2020, https://patientengagementhit.com/news/patients-face-geographic-barriers-to-
covid-19-testing-access; and T ori and Marsh, “ Over 67 Million Americans Lack Access to COVID-19 T esting: Where
Are T hese ‘T esting Deserts’?,” GoodRx, August 20, 2020.
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COVID-19 Testing: Frequently Asked Questions

rural areas and had populations with comparatively lower average incomes in comparison to other
areas with more reliable access.166 Another national study similarly found that counties with a
travel time of more than 20 minutes to a COVID-19 testing site had a higher percentage of the
population that were from racial and ethnic minority groups, were uninsured, and had lower
population density (i.e., rural).167 Further, media analyses found that, as of June 18, 2020, testing
sites in neighborhoods with disproportionately higher nonwhite populations faced higher demand
(though noted some data limitations in fully accounting for testing capacity at these sites).168
In addition, some academic studies have found testing disparities in specific locations. For
example, a study of New York City found that a number of tests conducted in a given zip code
was positively associated with the proportion of residents who identified as white.169 Other
studies showed similar racial disparities in West Virginia and Missouri.170 Some analyses have
also noted additional factors that could cause certain racial and ethnic minority communities to
disproportionately forgo needed testing, including distrust of the health care system, occupational
factors such as long work hours, or lack of health care coverage.171 While the increase in vaccine
uptake has significantly decreased the number of individuals seeking out COVID-19 testing,172
some states and localities are stil experiencing testing disparities.173
Analyses of testing disparities have been hindered by incomplete reporting of demographic data
for al tests conducted, including race/ethnicity. To date, eight states, plus the District of
Columbia, report race and ethnicity data for al testing data. Most other states report race and
ethnicity data for confirmed positive cases of COVID-19 only. Limitations in testing data,
therefore, have limited the ability to analyze and understand disparities in access to testing and, in
turn, may also limit understanding of disparities in disease transmission and acquisition rates,
especial y for those who do not require medical treatment.174 Despite the data limitations, some
available evidence show testing disparities, as summarized above.

166 See also Sarah Krouse, Brianna Abbott, and Daniela Hernandez, “Covid-19 T ests Are Still Hard to Get in Many
Communities,” The Wall Street Journal, January 22, 2021, https://www.wsj.com/articles/covid-19-testing-challenges-
remain-for-many-urban-rural-communities-11611320400.
167 CDC, “COVID-19 Racial and Ethnic Health Disparities: Risk of Exposure to COVID-19,” December 10, 2020,
https://www.cdc.gov/2019-ncov/community/health-equity/racial-ethnic-disparities/increased-risk-exposure.html and
168 Matthew Vann, Soo Rin Kim, and Laura Bronner, “ White Neighborhoods have more Access to COVID-19 T esting
Sites: ANALYSIS,” ABC News, June 22, 2020.
169 Wil Lieberman-Cribbin, Stephanie T uminello, Raja M. Flores, et al., “ Disparities in COVID-19 T esting and
Positivity in New York City,” Am erican Journal of Preventive Medicine, vol. 59, no. 3 (September 2020), pp. 326 -332.
170 Brian Hendricks, Rajib Paul, Cassie Smith, et al., “Coronavirus T esting Disparities Associated with Community
Level Deprivation, Racial Inequalities, and Food Insecurity in West Virginia, ” Annals of Epidem iology, vol. 59 (July
2021), pp. 44-49; and Aaloke Mody, Kristin Pfeifauf, Cory Bradley, et al., “ Understanding Drivers of Coronavirus
Disease 2019 (COVID-19) Racial Disparities: A Population-Level Analysis of COVID-19 T esting Among Black and
White Populations,” Clinical Infectious Diseases, December 14, 2020.
171 Georges C. Benjamin, Covid-19 Testing: Removing Barriers to Ensure Equitable Access, American Public Health
Association, April 22, 2020, https://www.covid19conversations.org/-/media/Files/PDF/COVID19/
Georges_Benjamin_Equity.ashx.
172 Michael Ollove, “U.S. COVID-19 T esting Has Dropped Dramatically,” PEW Charitable Trusts, March 22, 2021,
https://www.pewtrusts.org/en/research-and-analysis/blogs/stateline/2021/03/22/us-covid-19-testing-has-dropped-
dramatically.
173 See example, Lauren Peace, “Research confirms major racial disparities in West Virginia COVID testing,”
Mountain State Spotlight, May 27, 2021, https://mountainstatespotlight.org/2021/05/27/racial-disparities-wv-covid-
testing/.
174 Johns Hopkins Coronavirus Resource Center, “Racial Data T ransparency,” https://coronavirus.jhu.edu/data/racial-
data-transparency.
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To facilitate equity in testing access, various federal programs and initiatives have sought to
address disparities in testing access, alongside general efforts to boost testing capacity. HHS,
under the Trump Administration, sought to boost access to testing as a part of its efforts to address
the COVID-19 racial health disparities. Its primary strategies included (1) expanding testing at
federal y qualified health centers (see “Health Centers”), (2) supporting community-based retail
testing in areas with high social vulnerability,175 and (3) supporting state and local public health
capacity for testing programs through funding (see “Public Health Department Testing
Programs”).176 Several additional HHS programs have sought to address health disparities. For
example, through its Rapid Acceleration of Diagnostics (RADx) program, NIH funded $500
mil ion for a community-based research effort to develop and evaluate strategies for testing
programs in underserved communities, including populations such as racial and ethnic minority
populations or those living in nursing homes, jails, and rural areas.177 In addition, in summer
2020, CDC released its COVID-19 Response Heath Equity Strategy,178 which aimed to reduce
COVID-19 health disparities and increase testing, contact tracing, and other public health
measures for specific target populations, including racial and ethnic minorities, people with
disabilities, those experiencing homelessness, people living in rural areas, and other vulnerable
populations. The CDC provided action steps for local health jurisdictions and community partners
to take to reduce inequities in access to testing and other public health prevention measures,
including establishing partnerships with critical community partners and developing cultural y
and linguistical y responsible communication materials to boost testing access and uptake.
Independent analyses have found ongoing chal enges with federal and other efforts to expand
testing access and address disparities during the Trump Administration. For example, the National
Academy of Medicine noted, in an April 2021 impact assessment, that many of the federal retail
testing sites were not located in communities of color, citing a Vox media report.179 GAO also
noted that CDC’s health equity strategy lacked key elements of an effective national strategy. For
example, its stated goal to increase access to testing for populations at increased risk for COVID-
19 did not identify specific agency actions to achieve its stated goal.180
More recently, President Biden’s National Strategy for the COVID-19 Response and Pandemic
Preparedness cal s for expanding testing for schools and congregate living centers, ramping up
manufacturing of testing supplies and materials, and increasing genomic sequencing efforts.181 In
addition, his executive order to establish a Pandemic Testing Board highlights reducing disparities

175 As defined using CDC’s Social Vulnerability Index. See CDC/AT SDR, “CDC/AT SDR Social Vulnerability Index,”
April 28, 2021, https://www.atsdr.cdc.gov/placeandhealth/svi/index.html.
176 HHS, “HHS Initiatives to Address the Disparate Impact of COVID-19 on African Americans and Other Racial and
Ethnic Minorities,” https://www.hhs.gov/sites/default/files/hhs-fact-sheet-addressing-disparities-in-covid-19-impact-
on-minorities.pdf.
177 NIH, “NIH to Assess and Expand COVID-19 T esting for Underserved Communities,” September 30, 2020,
https://www.nih.gov.
178 CDC, “CDC COVID-19 Response Health Equity Strategy: Accelerating Progress T owards Reducing COVID-19
Disparities and Achieving Health Equity,” updated August 21, 2020, https://www.cdc.gov/coronavirus/2019-ncov/
community/health-equity/cdc-strategy.html.
179 Karen DeSalvo, Bob Hughes, and Mary Bassett, Public Health COVID-19 Impact Assessment: Lessons Learned and
Com pelling Needs, National Academy of Medicine, April 7, 2021, https://nam.edu/public-health-covid-19-impact-
assessment-lessons-learned-and-compelling-needs/ and
180 GAO, COVID-19: Sustained Federal Action Is Crucial as Pandemic Enters its Second Year, March 31 2021, pp. 79-
90, https://www.gao.gov/assets/gao-21-265.pdf.
181 National Strategy for the COVID-19 Response and Pandemic Preparedness, January 2020,
https://www.whitehouse.gov/wp-content/uploads/2021/01/National-Strategy-for-the-COVID-19-Response-and-
Pandemic-Preparedness.pdf.
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in access to testing as a key goal.182 The Biden Administration has also made several funding
announcements aimed at expanding testing access. For example, of the $12 bil ion that President
Biden had announced on March 17, 2021 for expansion of COVID-19 testing, $2.25 bil ion wil
be administered as CDC grants to SLTT public health departments to “improve testing and
contact tracing capabilities; develop innovative mitigation and prevention resources and services;
and, improve data collection and reporting to advance health equity and address social
determinants of health as they relate to COVID-19.”183 In addition, HHS directed almost $1
bil ion from ARPA to be designated for strengthening the COVID-19 response in rural
communities, including expansion of testing and other preventive services,184 and more than $32
mil ion to health centers that serve under-resourced communities for expanded COVID-19
testing, treatment, and vaccinations.185
There are currently limited evaluations of the Biden Administration’s testing efforts. Some
studies show that jurisdictions continue to note disparities among marginalized populations in
regard to access to testing. Some analyses have continued to find that in certain locations,
communities of color (including Hispanic and Black/African American populations) and rural
populations have had more limited access to testing than White and urban populations.186 Even
with disparities in access to testing, certain racial and ethnic minority communities, including
Black/African American and Hispanic groups, have experienced a disproportionate rate of
positive COVID-19 cases.187
Private Health Insurance Coverage of Testing
Private health insurance is the predominant source of health insurance coverage in the United
States. Private health insurance includes both the group market (largely made up of employer-
sponsored insurance) and the nongroup market (commonly referred to as the individual market,
which includes plans directly purchased from an insurer both on and off health insurance
exchanges).188 The federal government may regulate private health insurance plans, including by
requiring plans to cover certain benefits. Federal requirements may vary by coverage type.

182 Executive Order 13996, “ Establishing the COVID–19 Pandemic T esting Board and, establishment, and efforts to
ensure sustainable public health workforce for COVID-19 and other biological threats,” January 21, 2021.
183 HHS, “Biden Administration to Invest More Than $112 Billion to Expand COVID-19 T esting,” March 17, 2021,
https://www.hhs.gov/about/news/2021/03/17/biden-administration-invest -more-than-12-billion-expand-covid-19-
testing.html.
184 HHS, “HHS Announces Nearly $1 billion from American Rescue Plan for Rural COVID-19 Response,” May 4,
2021, https://www.hhs.gov/about/news/2021/05/04/hhs-announces-nearly-1-billion-from-american-rescue-plan-for-
rural-covid-19-response.html.
185 HHS, “HHS Awards Over $32 Million in American Rescue Plan Funding to Expand COVID-19 T raining and
Support for Health Centers,” April 29, 2021, https://www.hhs.gov/about/news/2021/04/29/hhs-awards-over-32-million-
american-rescue-plan-funding-expand-covid-19-training-support-health-centers.html.
186 See example, Katerina Brandt et al., “SARS-CoV-2 testing in North Carolina: Racial, ethnic, and geographic
disparities,” Health & Place, vol. 69, May 2021, https://www.sciencedirect.com/science/article/pii/
S1353829221000721?via%3Dihub; and Brian Hendricks et al., “ Coronavirus T esting Disparities Associated with
Community Level Deprivation, Racial Inequalities, and Food Insecurity in West Virginia,” Annals of Epidem iology,
vol. 59 (July 2021).
187 Katherine Mackey et al., “Racial and Ethnic Disparities in COVID-19-Related Infections, Hospitalizations, and
Deaths: A Systemic Review,” Annals of Internal Medicine, December 1, 2020, https://www.ncbi.nlm.nih.gov/research/
coronavirus/publication/33253040.
188 T he CRS Report R46359, COVID-19 and Private Health Insurance Coverage: Frequently Asked Questions has
additional background information on private health insurance and types of plans. Also see “ What T ypes of Plans Are
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The questions below address federal requirements related to private health insurance coverage of
COVID-19 testing, including types of tests that must be covered, coverage of related items and
services, coverage of testing for public health surveil ance and employment purposes, and
coverage of testing conducted by out-of-network providers. The questions address the types of
plans subject to federal COVID-19 testing coverage requirements, and whether states may impose
their own coverage requirements.
Are Private Health Insurance Plans Required to Cover Testing, and
Does That Differ by Type of Test?
Prior to the enactment of the Families First Coronavirus Response Act (FFCRA, P.L. 116-127),
no federal requirements specifical y mandated private health insurance coverage of items or
services related to COVID-19 testing.
Section 6001 of the FFCRA, as amended, requires most private health insurance plans to cover
COVID-19 testing, including administration of the test, and related items and services, as defined
in the act. The coverage must be provided without consumer cost-sharing, including deductibles,
copayments, or coinsurance.189 Prior authorization or other medical management requirements are
prohibited. These coverage requirements are discussed in more detail below.
FFCRA Section 6001(a)(1), as amended by the Coronavirus Aid, Relief, and Economic Security
Act (CARES, P.L. 116-136) Section 3201, describes the types of tests that must be covered, along
with the administration of such tests. In addition, the Department of Labor (DOL), HHS, and the
Treasury issued FAQ documents on April 11, 2020,190 June 23, 2020,191 and February 26, 2021192
(hereinafter, “Tri-Agency FAQ 42,” “Tri-Agency FAQ 43,” and “Tri-Agency FAQ 44,”
respectively), on the private health insurance coverage requirements in FFCRA and the CARES
Act.193
The acts together require coverage of in vitro diagnostics, as defined in FDA regulation,194that
detect SARS-CoV-2 or diagnose the virus that causes COVID-19 and that are approved, cleared,
or authorized for marketing by the agency or being marketed or clinical y used pursuant to an
al owed flexibility in FDA guidance. The acts didn’t explicitly state whether this included

Subject to the FFCRA and CARES Act Requirements?” in this report.
189 A deductible is the amount an insured consumer pays for covered health care serv ices before coverage begins (with
exceptions). Coinsurance is the share of costs, figured in percentage form, an insured consumer pays for a covered
health service. A copaym ent is the fixed dollar amount an insured consumer pays for a covered health service.
190 Department of Labor (DOL), HHS, and the T reasury, “ FAQS ABOUT FAMILIES FIRST CORONAVIRUS
RESPONSE ACT AND CORONAVIRUS AID, RELIEF, AND ECONOMIC SECURIT Y ACT IMPLEMENT AT ION
PART 42,” April 11, 2020, at https://www.cms.gov/files/document/FFCRA-Part-42-FAQs.pdf. Hereinafter referred to
as “T ri-Agency FAQ 42.”
191 DOL, HHS, and the T reasury, “FAQS ABOUT FAMILIES FIRST CORONAVIRUS RESPONSE ACT AND
CORONAVIRUS AID, RELIEF, AND ECONOMIC SECURIT Y ACT IMPLEMENT ATION PART 43,” June 23,
2020, at https://www.cms.gov/files/document/FFCRA-Part -43-FAQs.pdf. Hereinafter referred to as “ T ri-Agency FAQ
43.”
192 DOL, HHS, and T reasury, “FAQS ABOUT FAMILIES FIRST CORONAVIRUS RESPONSE ACT AND
CORONAVIRUS AID, RELIEF, AND ECONOMIC SECURIT Y ACT IMPLEMENT ATION PART 44,” February
26, 2021, at https://www.cms.gov/files/document/faqs-part -44.pdf. Hereinafter referred to as “ T ri-Agency FAQ 44.”
193 For a discussion of the agencies’ implementation authority and the force of law of these documents, see the “ Are
Plans Required to Cover T esting for Public Health Surveillance or Employmen t Purposes?” section of this report.
194 21 C.F.R. §809.3(a).
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serology testing.195 The Tri-Agency FAQ 42 interpreted the coverage requirement as applying to
diagnostic (i.e., molecular and antigen) and serological (i.e., antibody) tests.
Together, the acts, as interpreted by the agencies through guidance, also require coverage without
cost-sharing of
items and services furnished to an individual during [specified types of visits; discussed
below] that result in an order for or administration of [an applicable COVID-19 test; see
above], but only to the extent such items and services relate to the furnishing or
administration of such product or to the evaluation of such individual for pu rposes of
determining the need of such individual for such product.196
Per an example provided in guidance,
if the individual’s attending provider determines that other tests (e.g., influenza tests, blood
tests, etc.) should be performed during a visit ... to determine the need of such individual
for COVID-19 diagnostic testing, and the visit results in an order for, or administration of,
COVID-19 diagnostic testing, the plan or issuer must provide coverage for the related tests
under section 6001(a) of the FFCRA.197
In addition, consumers must not face cost-sharing for “facility fees” or other fees, to the extent
they are related to COVID-19 testing or related items and services that are required to be covered
under FFCRA Section 6001.198
The coverage requirements do not apply to any services or items furnished at a testing visit that
are not related to COVID-19 (e.g., if someone received testing or treatment for an unrelated
condition at the same visit). In addition, the law and guidance do not explicitly address coverage
and cost-sharing for the testing-“related” items and services discussed above, if the individual
does not ultimately receive the test.199 The coverage requirements also do not encompass
treatment for il nesses associated with COVID-19.200
Per FFCRA Section 6001(a)(2), the coverage requirements apply to the specified items and
services, discussed above, when furnished at visits including to health care provider offices
(including in-person and telehealth visits), urgent care centers, and emergency rooms. Per the Tri-
Agency FAQ 42, the requirements also apply at “nontraditional” settings, “including drive-
through screening and testing sites where licensed healthcare providers are administering
COVID-19 diagnostic testing.”201 Also see, in this section, “Are Plans Required to Cover Testing
for Public Health Surveil ance or Employment Purposes?”

195 Although both serology tests and molecular and antigen diagnostic tests meet the regulatory definition of “in vitro
diagnostic,” applicability to serology testing was not clear based only on the statutory language, as it refers to detection
and identification of the virus. Serology testing does not detect or identify the virus; rather, it detects antibodies. (See
the “What Are the Different T ypes of COVID-19 T ests?” section of this report for more information.)
196 FFCRA §6001(a)(2). Also see the T ri-Agency FAQ 42, including questions five, six, and eight.
197 T ri-Agency FAQ 42, question five. Also see T ri-Agency FAQ 44, question five.
198 For more information, see the T ri-Agency FAQ 43, question seven, including its footnote 16.
199 Per the T ri-Agency FAQ 42, question five, the coverage of related items and services is required when “the visit
results in an order for, or administration of, COVID-19 diagnostic testing.” T his language also appears in FFCRA
Section 6001(a)(2). T he statute and guidance do not explicitly address whether the coverage requirements apply if an
individual receives the related items and services, even for purposes of determin ing the need for COVID-19 testing, but
does not actually receive a COVID-19 test. Other federal and/or state requirements could be applicable.
200 For more information on private health insurance coverage of COVID-19 treatment, see CRS Report R46359,
COVID-19 and Private Health Insurance Coverage: Frequently Asked Questions.
201 See T ri-Agency FAQ 42, question eight regarding “nontraditional” visits. Also see question 13 for more information
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In addition, guidance indicates that the coverage requirements apply to at-home COVID-19 tests,
including at-home swab kits that may be sent to a lab for processing, when such tests are “ordered
by an attending health care provider who has determined that the test is medical y appropriate for
the individual,” as specified in guidance.202
These coverage requirements apply only to the specified items and services furnished during the
COVID-19 public health emergency period described in FFCRA, as of the date the FFCRA was
enacted (March 18, 2020).203
What Types of Plans Are Subject to the FFCRA and CARES
Act Requirements?
These requirements apply to individual health insurance coverage, fully insured smal - and large-
group coverage, and self-insured group plans.204 The individual and smal -group markets include
plans sold on and off the individual and smal -group health insurance exchanges, respectively.
This includes grandfathered individual or group plans, which are exempt from certain other
federal private health insurance requirements. Per the definition of individual health insurance
coverage cited in FFCRA, the coverage requirements do not apply to short-term, limited duration
insurance (STLDI). The Tri-Agency FAQ 42 specifies other types of private health insurance
coverage that are, or are not, subject to the COVID-19 testing coverage requirements.
This section of this report focuses mainly on coverage requirements for private sector plans
stemming from Section 6001 of the FFCRA and other federal provisions. Section 6006 of the
FFCRA separately addresses the Federal Employees Health Benefits Program (FEHB), which
provides health insurance to federal employees, retirees, and their dependents. That section
requires that no federal civil servants enrolled in a health benefits plan or FEHB enrollees may be
required to pay a copayment or other cost-sharing related to COVID-19 testing, administration of
the test, or related items and services for visits during the emergency period.205

about telehealth visits.
202 T ri-Agency FAQ 43, question four. Also see question three regarding “attending providers.”
203 Some FFCRA and CARES Act coverage requirements are contingent upon the declaration of the COVID -19 public
health emergency. T his was declared by the HHS Secretary on January 31, 2020, effective as of January 27, pursuant to
Section 319 of the Public Health Service Act (PHSA). Hence, the emergency period began on January 27, 2020, and
remains in effect as long as the declaration, or any renewal of it, is in effect. See “ Duration of Emergency Period” in
CRS Report R46316, Health Care Provisions in the Fam ilies First Coronavirus Response Act, P.L. 116 -127; and HHS,
Assistant Secretary for Preparedness and Response, “ Public Health Emergency Declarations,” at https://www.phe.gov/
emergency/news/healthactions/phe/Pages/default.aspx.
204 T he requirements are technically applicable to group health plans and health insurers offering individual and group
health insurance coverage. In this section, references to “plans” include applicable plans and insurers. More
information on the types of plans discussed in this paragraph, and the applicability of FFCRA and CARES Act
requirements to them, is available in CRS Report R46359, COVID-19 and Private Health Insurance Coverage:
Frequently Asked Questions.
205 For more information, see CRS Report R46316, Health Care Provisions in the Families First Coronavirus Response
Act, P.L. 116-127.
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Are Plans Required to Cover Testing for Public Health Surveillance
or Employment Purposes?
As discussed above, Section 6001 of the FFCRA, as amended by the CARES Act, general y
requires plans to cover specified testing for the detection or diagnosis of COVID-19 and
administration of such tests, without cost-sharing, during the COVID-19 emergency period.206
Following enactment of this provision, questions arose about the range of covered testing,
including whether plans must pay for testing that is not mainly intended for the clinical or
treatment needs of individual patients.207 These questions centered on whether Section 6001
compels plans to cover testing for other reasons, such as public health surveil ance or workplace
health purposes.208
Although the statutory language of Section 6001 does not articulate the precise circumstances
under which testing must be covered, it general y restricts the ability of plans to limit coverage of
COVID-19 testing. More specifical y, this Section indicates that plans cannot “impose prior
authorization or other medical management requirements” with respect to required COVID-19
testing coverage.209 Although the term is not defined for purposes of Section 6001, medical
management requirements commonly refer to standards or processes that plans follow to
determine medical y appropriate coverage parameters (e.g., limits on the frequency of covered
treatments, or the health care setting for a specific item or service).210 While this Section makes
clear that plans cannot use such techniques to restrict coverage of COVID-19 testing, the scope of
covered testing, and whether the provision compels plans to cover testing in al instances, have
been the subject of debate.211
Section 6001 authorizes the Secretaries of HHS, Labor, and the Treasury to implement the
provision “through sub-regulatory guidance, program instruction or otherwise” and the agencies
have issued FAQ documents that address the provision’s implementation.212 As the agencies have

206 See Families First Coronavirus Response Act, P.L. 116-127, §6001, 134 Stat. 201 (2020); Coronavirus Aid, Relief,
and Economic Security Act, P.L. 116-136, §3201, 134 Stat. 366 (2020) codified at 42 U.S.C. §1320b-5 note. For more
information on the definition of “emergency period” see “Duration of Emergency Period” in CRS Report R46316,
Health Care Provisions in the Fam ilies First Coronavirus Response Act, P.L. 116 -127.
207 See, for example, Letter from the National Association of Insurance Commissioners and the Center for Insurance
Policy and Research, to Alex Azar, Secretary of Health and Human Services, and Seema Verma, Administrator,
Centers for Medicare & Medicaid Services, at https://www.naic.org/documents/
government_relations_letter_to_azar.pdf..
208 See, for example, id.
209 42 U.S.C. §1320b-5 note.
210 Although not expressly applicable to Section 6001, other federal statutes and regulations use the term “medical
management.” See, for example, Consolidated Appropriations Act, 2021 ( P.L. 116-260), Section 111 of Division BB,
adding Section 2799A-1(f)(1)(F) to the Public Health Service Act (in the context of surprise medical billing, “ medical
management techniques” include concurrent review and prior authorization); 45 C.F.R. §147.130(a)(4) (clarifying that
with respect to coverage of certain preventive health services, nothing prohibits a health plan or insurer from “using
reasonable medical management techniques to determ ine the frequency, method, treatment, or setting” for the required
coverage). See also, Amy B. Monahan, T he Regulatory Failure to Define Essential Health Benefits, 44 AM. J. L. &
MED. 529, 544 (2018).
211 See, for example, Katie T homas, “Testing Nursing Home Workers Can Help Stop Coronavirus. But Who Should
Pay?,” New York Tim es (June 9, 2020), https://www.nytimes.com/2020/06/09/health/testing-coronavirus-nursing-
homes-workers.html. Also see Blake Farmer, Insurers May Only Pay For Coronavirus Tests When They’re ‘Medically
Necessary,’ National Public Radio (June 19, 2020), https://www.npr.org/sections/health-shots/2020/06/19/880543755/
insurers-may-only-pay-for-coronavirus-tests-when-theyre-medically-necessary.
212 42 U.S.C. §1320b-5 note; T ri-Agency FAQs 42, 43, and 44.
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noted in these documents, the FAQs do not carry the force of law, but they may inform regulated
parties about the agencies’ enforcement priorities.213 In June 2020, the agencies issued their FAQ
43 guidance document that addresses coverage of COVID-19 testing for surveil ance or
employment purposes.214 In this guidance, the agencies specified that testing “conducted to screen
for general workplace health and safety (such as employee ‘return-to-work’ programs), for public
health surveil ance for SARS-CoV-2, or for any other purpose not primarily intended for
individualized diagnosis or treatment of COVID-19 or another health condition is beyond the
scope of section 6001 of the FFCRA.”215
The most recent Tri-Agency FAQ 44 (issued in February 2021) reiterates that plans are not
required to provide coverage of COVID-19 testing for public health surveil ance or employment
purposes, but that plans could offer such coverage voluntarily.216 Some Members of Congress
have expressed a different view regarding Section 6001, indicating that FFCRA “makes clear that
health plans are required to cover, without any conditions or limitations, the specified items and
services related to diagnostic tests for the detection of COVID-19.”217 As of the date of this
report, it appears that the statutory text of Section 6001 has not been examined by a court.
Are Plans Required to Cover Multiple Tests and/or Tests for
Asymptomatic Individuals?
In addition to the debate described above, there have been other questions about coverage for
testing, including for asymptomatic individuals.
Per the Tri-Agency FAQs 43 and 44, coverage of testing is required for asymptomatic individuals,
whether or not they have had known or suspected recent exposure to SARS-CoV-2.218 The
coverage requirements also apply each time an individual receives a diagnostic test for COVID-
19, “provided that the tests are diagnostic and medical y appropriate for the individual, as
determined by an attending health care provider in accordance with current accepted standards of
medical practice.”219 FAQ 43 suggests that providers “consult guidance issued by the CDC, as
wel as state, tribal, territorial, and local health departments or professional societies, when

213 See, for example, T ri-Agency FAQ 44, at 1. For information on agency use and judicial review of general
statements of policy, see CRS Report R44468, General Policy Statem ents: Legal Overview.
214 See T ri-Agency FAQ 42.
215 Ibid., question five.
216 See T ri-Agency FAQ 44.
217 Letter from Frank Pallone, Jr., Chairman, Committee on Energy and Commerce, Robert C. “Bobby” Scott,
Chairman, Committee on Education and Labor, Richard Neal, Chairman, Committee on Ways and Means, Patty
Murray, Ranking Member, Committee on Health, Education, Labor, and Pensions, Ron Wyden, Ranking Member,
Committee on Finance, to Alex Azar, Secretary of Health and Human Services, Eugene Scalia, Secretary of Labor, and
Steven T . Mnuchin, Secretary of T reasury (July 7, 2020), https://edlabor.house.gov/imo/media/doc/
Democratic%20Health%20Leaders%20Demand%20T rump%20Administration%20Immediately%20Revisit%20Guida
nce%20Limiting%20COVID-19%20T esting%20Coverage.pdf.
218 Per T ri-Agency FAQ 43, question five, coverage of testing for asymptomatic individuals was only required if the
individuals had known or suspected exposure. T his was revised by T ri-Agency FAQ 44, question one, which states that
the known or suspected exposure is not required for coverage of individuals’ testing.
219 T ri-Agency FAQ 43, question six. T his question addresses coverage of multiple tests in general, not just for
asymptomatic individuals. Also see question three regarding “attending providers.”
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determining whether diagnostic testing is appropriate for a particular individual.220 FAQ 44
further states,
State and local public health authorities retain the authority to direct providers to limit
eligibility for testing based on clinical risk or other criteria to manage testing supplies and
access to testing. Responsibility for implementing such state or local limits on testing fals
on attending health care providers, not on plans and issuers. Plans and issuers may not use
such criteria to deny (or impose cost sharing on) a claim for COVID-19 diagnostic
testing.221
As discussed in the prior section, FAQ 43 indicates that plans are not required to cover COVID-
19 testing for public health surveil ance or employment purposes. This guidance was maintained
in FAQ 44, where questions one and two explain that although plans are required to cover testing
for individuals (including for asymptomatic individuals), plans are not similarly required to cover
testing for “groups of asymptomatic employees or individuals with no known or suspected recent
exposure to COVID-19” (emphasis added).
What Coverage and Provider Reimbursement Requirements Apply
to Out-of-Network Testing?
While Section 6001 of FFCRA establishes requirements for private health insurance plans to
cover COVID-19 testing, administration of the test, and related items and services, it does so
without regard to whether a provider is in a health plan’s network. See the text box below for
background on provider networks and private health insurance coverage.
Section 3202 of the CARES Act establishes a methodology for determining insurer payments to
in-network and out-of-network providers for COVID-19 testing, and the Tri-Agency FAQ 42
clarifies that the FFCRA coverage requirements apply both in-network and out-of-network.222 Per
guidance, Section 3202 of the CARES Act does not address the amount that a health plan must
reimburse a provider for any other item or service beyond COVID-19 testing.223

220 Ibid.
221 T ri-Agency FAQ 44, question one.
222 T ri-Agency FAQ 42, question seven.
223 T ri-Agency FAQ 43, question eight.
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In-Network and Out-of-Network Coverage in Private Health Insurance
In private health insurance, the amount paid for covered items and services is general y contingent upon whether a
consumer’s health plan has negotiated with a provider to enter into a contract. The contract between the health
plan and the provider general y specifies the total amount that a provider may receive for furnishing particular
items or services to that health plan’s enrol ees. A provider that enters into a contract with a health p lan is
considered to be part of the health plan’s network, otherwise referred to as being in-network.
A provider that does not enter into a contract with a health plan is considered out-of-network, and as such there is
no negotiated rate between the provider and the health plan. In situations involving services provided by an out-
of-network provider, the amount that a provider wil receive from a health plan depends on whether the health
plan covers out-of-network services. In situations where health plans do not cover out-of-network services, the
health plan wil not pay any amount to a provider for services provided to an enrol ee of the health plan. In
situations where plans do cover out-of-network services, as there is no negotiated rate between health plans and
out-of-network providers, health plans wil use their own methodologies for calculating how much they wil pay
out-of-network providers for services. If an out-of-network provider’s total charge for a service exceeds the
amount reimbursed by the health plan, the provider may directly bil (i.e., balance bil ) a consumer for the amount
of the difference, except when prohibited by applicable state law or other contractual agreements.
For more information, see CRS Report R46856, Surprise Bil ing in Private Health Insurance: Overview of Federal
Consumer Protections and Payment for Out-of-Network Services.
Under the CARES Act, if a health plan had a negotiated rate with a provider of diagnostic testing
prior to the declaration of the COVID-19 public health emergency declared under PHSA Section
319, then the health plan must apply that negotiated rate throughout the period of the COVID-19
public health emergency. If a health plan did not have a negotiated rate with a provider of
diagnostic testing prior to the emergency declaration, then the health plan must either reimburse
the provider an amount that equals the cash price for the COVID-19 testing, as listed on the
provider’s public website, or the health plan and provider may negotiate a rate that is less than the
cash price. If there is no cash price listed on the provider’s website and the two parties cannot
negotiate a rate, then the methodology for determining reimbursement depends on whether there
is an applicable state law.224
During the period of the COVID-19 public health emergency, providers of COVID-19 diagnostic
testing must make public the cash price for the COVID-19 test on the provider’s public website.
Section 3202 of the CARES Act does not include any further requirements for providers
regarding the cash price, including any limitation on the amount that a provider may post as the
cash price.
DOL, HHS, and the Treasury published an interim final rule (IFR) in the Federal Register on
November 6, 2020, to implement and clarify the FFCRA and CARES Act requirements related to
the coverage of COVID-19 diagnostic testing furnished by out-of-network providers.225 The IFR
clarified that a provider of a COVID-19 diagnostic test is required to post “a plain-language
description of each COVID-19 diagnostic test, the corresponding cash price, the bil ing code(s)
for each such test(s), and any additional information as may be necessary for the public to be
certain of the cash price for a particular COVID-19 diagnostic test.”226 If a provider of a COVID-
19 diagnostic test does not have its own website, then the provider must make public the

224 T ri-Agency FAQ 43, question 11.
225 Department of Health and Human Services, Department of Labor, and t he Department of the T reasury, “ Additional
Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency,” 85 Federal Register 71142,
November 6, 2020.
226 Ibid., 71153.
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information in writing within two business days upon request and on a sign prominently posted at
the location where the provider offers a COVID-19 diagnostic test.227
The HHS Secretary may impose a civil monetary penalty on a provider of COVID-19 diagnostic
testing that is not in compliance with the above requirement to post the cash price and has not
completed a corrective action plan to comply with the requirement. The amount of the civil
monetary penalty may not exceed $300 per day that the violation is ongoing.
Are Out-of-Network Providers Allowed to Balance Bill Patients for
COVID-19 Testing and Other Related Items and Services?
The Tri-Agency FAQ 43 clarifies that the combination of FFRCA requirement to provide
coverage for COVID-19 testing without cost-sharing, and the CARES Act methodology for
determining reimbursement for COVID-19 testing, means that an out-of-network provider is
general y precluded from directly bil ing a patient for the difference between provider’s charge
for COVID-19 testing and the amount reimbursed by the health plan (i.e., balance bil ).228
However, a provider is not prevented from balance bil ing for other items and services unless
there is an applicable state law or other prohibition (e.g., pursuant to the terms of the Provider
Relief Fund).229
May States Require Plans to Cover Additional Types or Purposes
of Testing?
States are the primary regulators of private health insurance, and each state may impose coverage
requirements on insurers and the plans they sel in that state.
With regard to COVID-19 testing, states may require coverage that exceeds applicable federal
requirements, as long as states do not prevent the implementation of any federal requirements.230
Some states have implemented expanded requirements, although some such state requirements
have been time-limited and may no longer be in effect.231
State requirements may apply to individual health insurance coverage, fully insured group
coverage, or both, but states cannot regulate self-insured group plans. States may impose
requirements on STLDI. (See “What Types of Plans Are Subject to the FFCRA and CARES
Act Requirements?” for information on plan types.)
A state or local department of health or other administrative agency may announce requirements
or guidelines regarding testing certain populations or testing for certain public health purposes.

227 Ibid., 71152.
228 Question nine in the T ri-Agency FAQ 43 points out that out -of-network providers who accept funds from the
Provider Relief Fund may not seek to collect from patients out -of-pocket expenses that would be “ greater than what the
patient would have otherwise been required to pay if the care had been provided by an in network provider.” For
background on this funding, see CRS Insight IN11438, The COVID-19 Health Care Provider Relief Fund.
229 Ibid.
230 See, for example, the introduction of the Tri-Agency FAQ 42.
231 Several organizations have been tracking these announcements by states. See, for example, the National Association
of Insurance Commissioners (NAIC), “ Life and Health” resource, updated December 10, 2020, at
https://content.naic.org/naic_coronavirus_info.htm. T o confirm whether a given state has enacted any requirements
related to coverage of COVID-19 testing (or related to other topics) that may not be reflected in that tracking document,
check with that state’s department of insurance: https://content.naic.org/state_web_map.htm.
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This does not necessarily mean that insurers in that state are required to cover such testing,
although that would be the case if the state department of insurance or other relevant agency also
requires such coverage, or if federal requirements are applicable.
Payment for Testing by Federal Programs: Medicare,
Medicaid, and CHIP
The Social Security Act (SSA) defines a federal health care program as any plan or program that
provides health benefits—whether directly, through insurance, or otherwise—and that is funded
directly, in whole, or in part by the U.S. government (with the exception of the Federal
Employees Health Benefits Program) or one of four specified state health care programs.232 Key
federal health programs include (1) Medicare, the national health insurance program that pays for
covered services furnished to beneficiaries (general y the elderly and disabled); (2) Medicaid, the
federal-state program for certain low-income individuals; and (3) the State Children’s Health
Insurance program (CHIP), which provides coverage for low-income, uninsured children. The
questions below discuss how these federal health care programs provide, establish coverage, or
pay for testing for their beneficiaries. FFCRA, as amended by the CARES Act, required each of
these programs to cover COVID-19 testing for their enrollees without beneficiary cost-sharing,
under certain circumstances. For Medicaid, COVID-19 testing is expanded and extended under
the ARPA. The specific testing-related requirements associated with each program are discussed
below. In general, these federal health care programs provide coverage for testing of beneficiaries
when ordered by an enrollee’s physician or practitioner.233
How Does Medicare Pay for Testing, and Does That Differ by Type
or Use of Test?
In general, Medicare covers health care services furnished to diagnose or rule out a possible
il ness or condition.234 Medicare pays for clinical laboratory tests that are medical y necessary and
ordered by a beneficiary’s physician or practitioner for such purposes.235 There is no cost-sharing
required under Part B, or for beneficiaries enrolled in Medicare Advantage (MA) plans, as MA
plans must cover al benefits under Medicare Parts A and B.236

232 Social Security Act (SSA) §1128B(f) [42 U.S.C. §1320a–7b]. T he four state health care programs are Medicaid
(SSA title XIX), Maternal and Child Health Services Block Grant (SSA title V), Block Grants and Programs for Social
Services (SSA title XX). T he State Children’s Health Insurance Program (CHIP) is included among the list of four
programs that are considered to be a state health care program. CHIP is added as a state health care program by
reference at SSA Section 2107(e)(2) [42 U.S.C. 1397gg].
233 For adults under the Medicaid program, states are permitted to limit the extent to which a covered benefit is
available under the state plan by defining medical necessity criteria, and the amount, duration, and scope of covered
services (see SSA Section(s) 1901; 1902(a)(30)(A); and 1903(m)(2)(A)(vii)). For children under Medicaid and CHIP
Medicaid expansion programs, medical necessity requirements are established under Early and Periodic Screening,
Diagnostic, and T reatment (EPSDT ) (see SSA Section 1905(r)( 5)). For separate CHIP programs, medical necessity
requirements are established under SSA Section 2110(a)(24).
234 SSA Section 1862(a)(1)(A) specifies that Medicare covered health care services must be “reasonable and necessary
for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.”
235 Some preventive or screening tests may also be covered, but these are explicitly addressed in SSA Section
1862(a)(1)(B)-(P) (e.g., screening tests for mammography, prostate cancer, and colorectal cancer).
236 See CRS Report R40425, Medicare Primer for information about Medicare.
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HHS has assigned testing for coronavirus as an essential health benefit so the test must be
covered under Medicare Part B. However, the coronavirus test must be ordered by a doctor or
health care provider. Clinical tests to diagnose or aid in the diagnosis of the coronavirus disease,
as wel as some tests for related respiratory conditions given with the COVID-19 test, are
covered.237 FDA-authorized antibody (serology) tests for those beneficiaries diagnosed with a
known current or prior COVID-19 infection or suspected current or past COVID-19 infection are
also covered with no cost-sharing.238 There is no limit on the number of tests, so long as each test
satisfies the coverage requirement.
The FFCRA eliminated the Medicare Part B beneficiary cost-sharing for provider visits during
which a coronavirus diagnostic test is administered or ordered during the emergency period.
Beneficiaries are not responsible for any coinsurance payments or deductibles for any specified
COVID-19 testing-related service, defined as a medical visit that fal s within the evaluation and
management service codes for the following categories: office and other outpatient services;
hospital observation services; emergency department services; nursing facility services;
domiciliary, rest home, or custodial care services; home services; or online digital evaluation and
management services.
Surveil ance testing, whether it be for the novel coronavirus or other purposes, does not meet the
Medicare coverage criteria that the care be “reasonable and necessary for the diagnosis or
treatment of il ness or injury or to improve the functioning of a malformed body member.”
Similarly, COVID-19 testing for “return-to-work” would not be covered under Medicare.
How Does Medicaid Pay for Testing, and Does That Differ by Type
or Use of Test?
Medicaid is a joint federal-state program that finances the delivery of primary and acute medical
services, as wel as long-term services and supports (LTSS), to a diverse low-income population,
including eligible children, pregnant women, adults, individuals with disabilities, and people aged
65 and older. States have flexibility to design their own versions of Medicaid within the federal
statute’s basic framework. This flexibility results in variability across state Medicaid programs
regarding factors such as eligibility and covered benefits.
Section 6004 of the FFCRA, as amended by Section 3717 of the CARES Act, requires state
Medicaid programs to cover testing and testing-related services239 without beneficiary cost-
sharing under traditional Medicaid240 beginning on or after March 18, 2020, through the public

237 CMS, “Coronavirus disease 2019 (COVID-19) tests” at https://www.medicare.gov/coverage/coronavirus-disease-
2019-covid-19-tests.
238 CMS “Coronavirus disease 2019 (COVID-19) antibody test” at https://www.medicare.gov/coverage/coronavirus-
disease-2019-covid-19-antibody-test. For information about molecular pathogen tests versus screening antibody
serology tests, see CRS In Focus IF11516, COVID-19 Testing: Key Issues.
239 CMS interpreted COVID-19 testing-related services to include items and services for which payment is available
under the Medicaid state plan that are directly related to the administration of COVID-19 testing, or for the evaluation
of an individual to determine the need for COVID-19 testing (e.g., an X-ray). For more information, see Centers for
Medicare and Medicaid Services (CMS), Fam ilies First Coronavirus Response Act (FFCRA), P.L. 116-127;
Coronavirus Aid, Relief, and Econom ic Security (CARES) Act, P.L. 116-136; Frequently Asked Questions (FAQ), April
13, 2020.
240 T he FFCRA provision is silent about the addition of this benefit under Medicaid alternative benefit plans (ABPs).
Most Medicaid beneficiaries receive services via traditional Medicaid. However, states also may furnish Medicaid in
the form of ABPs. States that choose to implement the ACA Medicaid expansion are required to provide ABP coverage
to the individuals eligible for Medicaid through the expansion (with exceptions for selected special-needs subgroups).
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link to page 56 COVID-19 Testing: Frequently Asked Questions

health emergency period, as defined.241 Section 9811 of the ARPA expands and extends this
benefit by adding testing for COVID-19 without beneficiary cost-sharing to the list of Medicaid
mandatory services under traditional Medicaid and alternative benefit plan coverage for the
period that begins on the date of enactment of ARPA (i.e., March 11, 2021) and ends the last day
of the first calendar quarter that begins one year after the last day of the public health emergency
period, as defined.
Testing services are defined as in vitro diagnostic products as defined in FDA regulation242
including the administration of such products, for the detection of SARS-CoV-2 or the diagnosis
of COVID-19. According to guidance from the Centers for Medicare & Medicaid Services
(CMS), the FDA has advised that serological tests for COVID-19 meet the FDA definition of an
in vitro diagnostic product for the detection of SARS-CoV-2 or the diagnosis of COVID-19, and
thus must be covered under Medicaid for symptomatic and asymptomatic Medicaid enrollees, as
long as such tests are driven by medical necessity.243 To date, the Medicaid specific CMS
guidance has not explicitly addressed the question of whether states can use Medicaid as a payer
of public health surveil ance testing for SARS-CoV-2 (to screen for general workplace health and
safety, as in the case of employee “return to work” programs).
How Does CHIP Pay for Testing, and Does That Differ by Type or
Use of Test?
CHIP provides health insurance coverage to low-income, uninsured children in families with
incomes above applicable Medicaid income standards, and to certain pregnant women. States
have the flexibility to design their own versions of CHIP within the federal statute’s basic
framework. This flexibility results in variability across state CHIP programs regarding factors
such as eligibility and covered benefits.
FFCRA, as amended by the CARES Act, also requires CHIP programs to cover COVID-19
testing and testing-related services244 without beneficiary cost-sharing for CHIP enrollees for the

Under ABPs, states may furnish a benefit that is defined by reference to an overall coverage benchmark that is based on
one of three commercial insurance products (e.g., the commercial health maintenance organization (HMO) with th e
largest insured commercial, non-Medicaid enrollment in the state) or a fourth, “ Secretary-approved” coverage. For
more information on Medicaid ABP coverage, see CRS Report R45412, Medicaid Alternative Benefit Plan Coverage:
Frequently Asked Questions.
241 FFCRA, as amended by the CARES Act, also added a new optional Medicaid “COVID-19 testing” eligibility group
to provide testing and diagnosis of COVID-19 for certain specified uninsured individuals during the COVID-19 public
health emergency. For more information on this optional eligibility group and the limited benefit coverage enrollees in
this group are entitled to, see the “ Under What Circumstances Will Medicaid Pay for Uninsured T esting?” section of
this report.
242 21 C.F.R. 809.3(a) defines in vitro diagnostic products as “reagents, instruments, and systems intended for use in the
diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat ,
or prevent disease or its sequelae. Such products are intended for use in the collection, preparation, and examination of
specimens taken from the human body.” T o date, FDA has authorized one emergency use authorization for a
serological test that is intended for use by clinical laboratories. See U.S. Food and Drug Administration, Letter to
Cellex Inc. Regarding qSARS-CoV-2 IgG/IgM Rapid T est (April 1, 2020), available at https://www.fda.gov/media/
136622/download.
243 CMS, “Families First Coronavirus Response Act (FFCRA), P.L. 116-127; Coronavirus Aid, Relief, and Economic
Security (CARES) Act, P.L. 116-136; Frequently Asked Questions (FAQs),” April 13, 2020,
https://www.medicaid.gov/state-resource-center/downloads/covid-19-section-6008-CARES-faqs.pdf (hereinafter, CMS
Medicaid FAQs).
244 CMS interpreted COVID-19 testing-related services for Medicaid to include items and services for which payment
is available under the Medicaid state plan that are directly related to the administration of COVID-19 testing, or for the
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period beginning March 18, 2020, through the duration of the public health emergency period, as
specified. Section 9821 of the ARPA extends this requirement for the period that begins on the
date of enactment of ARPA (i.e., March 11, 2021) and ends the last day of the first calendar
quarter that begins one year after the last day of the public health emergency period, as defined.
CMS guidance clarifies that, as under Medicaid, such testing must include diagnostic and
serological tests for symptomatic and asymptomatic CHIP program enrollees when testing is
driven by medical necessity.245 To date, the CHIP specific CMS guidance has not explicitly
addressed the question of whether states can use CHIP as a payer of public health surveil ance
testing for SARS-CoV-2 (to screen for general workplace health and safety, as in the case of
“return to school” programs).
Provision of and Payment for COVID-19 Testing by
Federal Systems: BOP, IHS, VA, DOD, and FEMA
In general, the federal government pays for care provided by nonfederal providers. In the cases of
the Indian Health Service (IHS), the Veterans Health Administration (VHA), and the DOD
through the Defense Health System, the federal government may provide care directly to a
limited set of beneficiaries enrolled in these programs. Other federal programs, that that do not
have as their primary purpose the delivery of health care, may also, in some cases, directly
provide services to individuals who reside in their facilities (for example, the Bureau of Prisons
(BOP) may provide care to federal inmates). The questions below focus on federal agencies that
directly provide health services to a set of individuals and how these systems provide and pay for
testing for their service populations. FFCRA included requirements for federal health systems to
provide or pay for testing for IHS, the VHA and DOD. The specific requirements for each agency
are discussed in the questions below. In addition, federally operated health systems general y do
not provide care to non-beneficiaries except under limited circumstances, some of which have
arisen as part of the COVID-19 pandemic. The provision of testing services to non-beneficiaries
is also discussed in the questions below.
How Does the Bureau of Prisons Provide or Pay for Testing?
The Bureau of Prisons within Department of Justice (DOJ) operates the federal prison system,
which includes 122 BOP-operated prisons in 35 states.246 BOP was established in 1930 to house
federal prisoners, professionalize the prison service, and ensure consistent and centralized
administration of the federal prison system.247 BOP must confine any offender convicted and
sentenced to a term of imprisonment in a federal court. BOP provides medical y necessary
treatment to al federal prisoners in a manner consistent with the standards of care for
nonprisoners.248 Most of this treatment is provided through health care clinics that are operated in

evaluation of an individual to determine the need for COVID-19 testing (e.g., an X-ray). When defining testing-related
services available under CHIP, the CMS guidance points to Medicaid specific responses in the Q&A. For more
information, see CMS Medicaid FAQs.
245 CMS Medicaid FAQs.
246 U.S. Department of Justice, Bureau of Prisons, Our Locations, https://www.bop.gov/locations/.
247 U.S. Department of Justice, Bureau of Prisons, About the Bureau of Prisons, June 2015, p. 1.
248 GAO notes, “Multiple U.S. courts over the years have determined that inmates have a constitutional right to
adequate medical and mental health care.” U.S. Government Accountability Office, Bureau of Prisons: Better Planning
and Evaluation Needed to Understand and Control Rising Inm ate Health Care Costs, GAO-17-379, June 2017, pp. 2,
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each BOP facility.249 When services cannot be provided at a BOP facility, BOP wil transport
prisoners to a community health care facility or provider (e.g., a hospital).
According to DOJ’s Office of the Inspector General (OIG), testing of federal prisoners “evolved
between February and August 2020, in response to [Centers for Disease Control and Prevention]
recommendations, the availability of tests, and the evolution of outbreaks in BOP facilities.”250
According to OIG, since March 2020, BOP’s guidance has expanded to include testing both
symptomatic and asymptomatic prisoners.251 Prison administrators consult with BOP medical
officials to prioritize testing if there are limits on the number of tests that can be performed at a
specific facility.252 Most of the COVID-19 tests administered by BOP from February 2020 to
August 2020 were viral tests, and BOP used both commercial molecular tests and rapid molecular
RNA tests.253 BOP sent some test samples to commercial laboratories for processing, but BOP
also tested some samples onsite at prison facilities by using rapid molecular RNA testing
machines BOP received from the Strategic National Stockpile.254 Because of their sensitivity and
specificity, commercial molecular tests were used by BOP in some specific situations, such as
when a prisoner was set to be released from quarantine, and rapid molecular tests in others, such
as when prisoners appeared to be symptomatic and rapid results were beneficial.255 BOP tested
approximately 150,000 of the nearly 218,500 prisoners in its custody from February 2020 to
August 2020.256
The cost of providing health care to federal prisoners is covered by appropriations from BOP’s
Salaries and Expenses account in the annual Commerce, Justice, Science, and Related Agencies
(CJS) Appropriations Act. The Coronavirus Aid, Relief, and Economic Security Act (CARES Act,
P.L. 116-136) also included $100 mil ion for BOP to “prevent, prepare for, and respond to
coronavirus, domestical y or international y, including the impact of coronavirus on the work of
[DOJ].” The FY2021 CJS Appropriations Act (P.L. 116-260) included a general provision that
provided an additional $300 mil ion for BOP to respond to the COVID-19 pandemic that was in
addition to the amount provided for BOP’s S&E account.
How Does the Indian Health Service Provide or Pay for Testing?
IHS within HHS is the lead federal agency charged with improving the health of Americ an
Indians and Alaska Natives. In FY2019, IHS provided health care to approximately 2.6 mil ion
eligible American Indians/Alaska Natives.257 IHS has 12 areas, and the Navajo area represents

8.
249 For more information on how health care is provided to federal prisoners, see CRS In Focus IF11629, Health Care
for Federal Prisoners.
250 Pandemic Response Accountability Committee, Federal COVID-19 T esting Report: Data Insights from Six Federal
Health Care Programs, p. 48 (hereinafter “ Federal COVID-19 T esting Report ”).
251 Federal COVID-19 T esting Report, p. 48.
252 Ibid.
253 Ibid., p. 51.
254 Ibid., p. 11.
255 BOP reported that onsite rapid test results were typically available in 15 minutes, but commercial vendor test results
were usually returned within two to four days. However, some facilities experienced wait times of 10 to 14 days for
results in late July and early August because of a nationwide spike in cases and corresponding increased demand for
testing. Federal COVID-19 T esting Report, pp. 51, 53.
256 BOP acknowledges that the data it submitted for OIG’s review of COVID-19 testing in federal prison is not
complete and probably underestimates the amount of testing conducted. Federal COVID-19 T esting Report, p. 48.
257 HHS, Indian Health Service (IHS), FY2021, “Justification of Estimates for Appropriations Committees,”
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one of the highest COVID-19 death rates national y.258 IHS provides care free of charge to its
beneficiaries, who are general y members of federal y recognized tribes.259 These services include
COVID-19 testing. IHS reports that most of its facilities have testing capacity, and it has been
making data on testing at the area level available on its website.260 To expand testing, IHS
received and provided 470 rapid test analyzers to facilities in its system, prioritizing sites near hot
spots and those that were not near centralized lab capacity. IHS also received 300,000 rapid
Abbott BinaxNOW Ag CARD point-of-care tests, which the agency prioritized for use by
IHS/Indian Tribes/Tribal Organizations/Urban Indian Organizations that operate health programs
that serve students enrolled in Bureau of Indian Education schools, students at tribal colleges and
universities, or residents of elder care facilities.261
IHS has received nearly $8 bil ion in supplemental funding for COVID-19-related testing and
care.262 FFCRA provided an additional $64 mil ion, to remain available until September 30, 2022
(i.e., through FY2021), for specified COVID-19 testing and related health services and
administration.263 The act also requires IHS to pay the cost of providing any COVID-19-related
items and services without imposing any cost-sharing requirements for the period of the COVID-
19 emergency. This requirement applies to any American Indian264 receiving services through the
IHS,265 including through Urban Indian Organizations. General y, IHS facilities operated by the
Indian Health Service do not charge cost-sharing; however, facilities that are operated by Indian
tribes or by Urban Indian Organizations may do so. The CARES Act provided an additional
$1.032 bil ion to IHS to prevent, prepare for, and respond to the coronavirus. This funding was
not explicitly for testing, but it may be used for testing. PPPHCEA also appropriated $750 mil ion
the Public Health and Social Services Emergency Fund (PHSSEF) to be al ocated by IHS for
testing capacity. APRA provided $6.09 bil ion to IHS for a variety of specified purposes related to
COVID-19 testing, treatment, vaccination and other coronavirus-related preparedness and
response activities.266 The Biden Administration announced that $1 bil ion would be al ocated to
testing, contact tracing, and other strategies to mitigate the spread of the coronavirus.267

https://www.ihs.gov/sites/budgetformulation/themes/responsive2017/display_objects/documents/FY_2021_Final_CJ-
IHS.pdf. IHS provides health care directly through facilities it operates, or through facilities that are operated by Indian
T ribes/T ribal Organizations or Urban Indian organizations.
258 Kenzi Abou-Sabe, Cynthia McFadden and Didi Martinez, “'Hit us at our core’: Vulnerable Navajo Nation fears a
second COVID-19 wave,” August 3, 2020, https://www.nbcnews.com/specials/navajo-nation-fears-second-covid-19-
wave/index.html.
259 For definition of Indian T ribe see Section 4 of the Indian Health Care Improvement Act (25 U.S.C. §1603(14)).
260 See HHS, IHS, “Coronavirus (COVID-19),” https://www.ihs.gov/coronavirus/.
261 HHS, IHS “Coronavirus (COVID-19), FAQs—Federal Response in Indian Country,” https://www.ihs.gov/
coronavirus/faqs-federal-response-in-indian-country/.
262 For a discussion of funding provided to the Indian Health Service and Indian T ribes to prepare for and respond to
the coronavirus, see CRS Insight IN11333, COVID-19 and the Indian Health Service.
263 CRS Report R46316, Health Care Provisions in the Families First Coronavirus Response Act, P.L. 116 -127.
264 FFCRA defines Indian with a reference to Section 4 of the Indian Health Care Improvement Act (25 U.S.C.
§1603(13)).
265 T he phrase “receiving services through the IHS” is not defined, but it has been used in prior federal guidance to
refer to non-IHS facilities that have care coordination agreements with IHS facilities to treat American Indians and
Alaska Natives. See Lett er to State Health Official: Re: Federal Funding for Services “ Received T hrough” an
IHS/T ribal Facility and Furnished to Medicaid-Eligible American Indians and Alaska Natives (SHO #16 -002),
February 26, 2016, https://www.medicaid.gov/sites/default/files/Federal-Policy-Guidance/Downloads/ sho022616.pdf.
266 See Sec. 11001 of P.L. 117-2.
267 “Biden Administration Funds $1B for COVID-19 T esting in Indian Country,” 360DX, April 16, 2021,
ttps://www.360dx.com/research-funding/biden-administration-funds-1b-covid-19-testing-indian-
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Does the Department of Veteran Affairs Offer or Pay for Testing?
The Veterans Health Administration (VHA) of the Department of Veterans Affairs (VA) operates
one of the nation’s largest integrated direct health care delivery systems.268 The VHA estimated
that in FY2020 it would provide care to about 6.33 mil ion unique veteran patients.269 In the same
year, the VHA estimated that it wil employ a staff of about 347,000 full-time equivalent
employees270 at approximately 1,456 VA sites of care,271 with an appropriation of approximately
$80.6 bil ion.272 The VHA provides a standard medical benefits package to enrolled veterans for
services both related to and unrelated to their military service.273 These services include COVID-
19 testing. The VHA has completed more than 3.3 mil ion diagnostic tests for COVID-19.274 The
VA has been making some data regarding testing publicly available on its website.275
Diagnostic testing is general y a covered service under the standard medical benefits package.276
Some veterans are required to pay copayments for care that is not related to a service-connected
disability. However, routine lab tests are exempt from copayment requirements.277 Furthermore,
the FFCRA prohibited the VA from charging any copayment or other cost-sharing payments for
COVID-19 testing or medical visits during any period of this public health emergency.278
The VA has received supplemental funding for COVID-19-related testing and care.279 The
FFCRA provided an additional $30 mil ion to the VHA medical services account, to remain
available until September 30, 2022 (i.e., through FY2021) to fund health services and related
items pertaining to COVID-19.280 The CARES Act provides supplemental appropriations for

country?adobe_mc=MCMID%3D92168907610703755799 155602916300127059%7CMCORGID%3D138FFF2554E6
E7220A4C98C6%2540AdobeOrg%7CT S%3D1619469140&CSAuthResp=1%3A%3A2425805%3A1911%3A24%3A
success%3A217E8B49928F9ABAF593DDCAE9164D34#.YIcjYpBKhME.
268 T he Veterans Health Administration (VHA) operates under a different m odel from the predominant health care
financing and delivery model in the United States, in which there is a payer for health care services (e.g., Medicare or
private health insurance plan), a provider (e.g., hospital, physician), and a recipient of care ( the patient). T he VHA is
not a health insurance financing program that provides reimbursement to providers for all or a portion of a patient’s
health care costs. T he VHA is primarily a direct provider of care; it owns the hospitals and employs the clinicia ns.
269 Department of Veterans Affairs (VA), FY2021 Congressional Submission, Medical Programs and Information
Technology Program s, vol. 2 of 4, February 2020, p. VHA-19.
270 VA, FY2021 Congressional Submission, Budget in Brief, February 2020, p. BiB-4.
271 Ibid., p. BiB-11. (Sites of care used in this calculation are VA hospitals, community living centers, health care
centers, community-based outpatient clinics [CBOCs], other outpatient service sites, and dialysis centers.)
272 VA, FY2021 Congressional Submission, Supplemental Information &Appendices, vol. 1 of 4, February 2020, p.
Supplemental Information-1.
273 For more information on the VHA health system in general, including who can enroll and the services that provided,
see CRS Report R42747, Health Care for Veterans: Answers to Frequently Asked Questions.
274 VHA Daily COVID-19 Update, April 21, 2021.
275 See VHA, VA, “Novel Coronavirus Disease (COVID-19),” https://www.publichealth.va.gov/n-coronavirus/.
276 38 C.F.R. §17.38.
277 38 C.F.R. §17.108(e)(14).
278 Generally, diagnostic testing is a covered service under VA’s standard medical benefits package, which is available
to all veterans enrolled in the VA health care system (38 C.F.R. §17.38). Some veterans are required to pay copayments
for care that is not related to a service-connected disability. However, routine lab tests are exempt from copayments.
(38 C.F.R. §17.108(e)(14)). Prior to enactment of FFCRA, it was unclear whether VA was including COVID-19 testing
under this exemption.
279 For a discussion of funding provided to VA to prepare for and respond to the public health emergency, see CRS
Report R46340, Federal Response to COVID-19: Departm ent of Veterans Affairs.
280 VHA’s annual appropriations consist of five accounts: medical services, medical community care, medical support
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FY2020 for certain VA accounts totaling $19.6 bil ion, designated as emergency spending. The
VHA medical services account received $14.4 bil ion of that total, which is partial y intended for
testing.281 Furthermore, ARPA Section 8002 added a supplemental appropriation for FY2021 to
remain available until September 30, 2023 (i.e., through FY2022) of $14.5 bil ion to be used for
medical care and health needs, which can include testing.
Can the IHS and the VA Provide Testing for Individuals Who Are
Not Otherwise Eligible for Services?
General y, health services at facilities operated by the IHS are limited to IHS beneficiaries who
are general y members of Indian tribes. Facilities operated by Indian tribes, tribal organizations,
or Urban Indian Organizations may serve non-IHS beneficiaries, but they may not use IHS funds
to do so. The Indian Health Care Improvement Act (IHCIA, P.L. 94-437), which provides general
authority for much of IHS’s activities, permits IHS facilities to serve non-beneficiaries under
limited circumstances, as specified in Section 813 (25 U.S.C. §1680). These circumstances
include preventing the spread of a communicable disease or to address a health hazard. IHS
provided guidance to tribal facilities stating that tribes may choose to provide care to non-
beneficiaries to reduce COVID-19 spread, including, but not limited to, members of Indian
households who are not otherwise eligible for IHS services. In this guidance, IHS noted that the
decision to provide services to non-beneficiaries would be made at the local level.282 IHCIA
general y requires that services provided to non-beneficiaries be reimbursed. As such, individuals
who have another source of coverage would be tested at an IHS-facility bil ed to the relevant
payer. HRSA has stated in its Frequently Asked Questions about the uninsured fund that COVID-
19 testing that IHS facilities provide to non-IHS beneficiaries may be reimbursed by the
uninsured fund if the individual tested does not have another source of payment.283
Similarly, VA health services provided through the VHA are general y limited to veteran enrollees
who are subject to specified eligibility and enrollment criteria.284 The VHA’s primary function is
to “provide a complete medical and hospital service for the medical care and treatment of
veterans” (38 U.S.C. §7301). However, the VA may provide hospital care and medical services
through a number of legal authorities to other individuals during periods of war, national
disasters, emergencies, or humanitarian crisis.
The Veterans Administration and Department of Defense Health Resources Sharing and
Emergency Operations Act (P.L. 97-174) was enacted to serve as the primary health care backup
to the military health care system during and immediately following an outbreak of war or a
national emergency.285 Since then, Congress has provided additional authorities to the VA to “use

and compliance, medical facilities, and medical and prost hetic research accounts. T he first four accounts cover the
provision of health care and related services.
281 Based on Senate Appropriations Committee, Coronavirus Supplemental Appropriations Summary, available at
https://www.appropriations.senate.gov/download/coronavirus-emergency-supplemental-appropriations-summary.
282 HHS, IHS, “IHS COVID-19 Interim Guidance for Care Services to Non-Beneficiaries,” March 20, 2020,
https://www.ihs.gov/sites/coronavirus/themes/responsive2017/display_objects/documents/IHS_COVID-
19_InterimGuidanceCareServices_Non-Beneficiaries.pdf.
283 HHS, HRSA, “Frequently Asked Questions,” https://www.hrsa.gov/coviduninsuredclaim/frequently-asked-
questions?field_faq_category_tid=All&combine=indian.
284 For a detailed discussion of eligibility for VA health care and qualification for enr ollment, see CRS Report R42747,
Health Care for Veterans: Answers to Frequently Asked Questions.
285 38 U.S.C. §811A.
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its vast infrastructure and resources, geographic reach, deployable assets, and health care
expertise, to make significant contributions to the Federal emergency response effort in times of
emergencies and disasters.”286
The VHA may care for nonveterans and veterans not enrolled in the VA health care system.287 The
VA also has authority to provide certain health services such as medical counter measures288 to
VA employees.289 The authority to care for nonveterans applies in situations where the President
has declared a major disaster or emergency under the Robert T. Stafford Disaster Relief and
Emergency Assistance Act (Stafford Act), or where the HHS Secretary has declared a disaster or
emergency activating the National Disaster Medical System established pursuant to Section
2811(b) of the Public Health Service Act (42 U.S.C. §300hh-11(b)). The President’s March 13,
2020, declaration of a national emergency under Section 501(b) of the Stafford Act al ows the VA
to use this authority.
Does the Department of Defense Offer or Pay for Testing?
Under Chapter 55 of Title 10, U.S. Code, the DOD administers statutory health entitlements to
approximately 9.6 mil ion beneficiaries (i.e., servicemembers, military retirees, and family
members).290 Collectively, these entitlements are organized under a program cal ed TRICARE
that is administered by the Military Health System (MHS). The MHS offers health care services
in military hospitals and clinics—known as military treatment facilities (MTFs)—and through
civilian health care providers participating in TRICARE.291 With the exception of active duty
servicemembers, MHS beneficiaries may have a choice of TRICARE plan options depending on
their status and geographic location. Each plan option has different beneficiary cost-sharing
features, including annual enrollment fees, deductibles, copayments, and an annual catastrophic
cap.292
COVID-19 diagnostic and serologic testing is a TRICARE-covered benefit when deemed
medical y necessary by a health care provider.293 Beneficiaries may receive COVID-19 testing at

286 VA, Department of Veterans Affairs FY 2018—2024 Strategic Plan, Refreshed May 31, 2019, May 31, 2019, p. 35.
287 38 U.S.C. §1785 and 38 C.F.R. §17.86 establish VA authority to provide hospital care and medical services to
nonveterans responding to, involved in, or otherwise affected by a disaster or emergency. T hese individuals may
include active duty servicemembers, as well as National Guard and Reserve component members activated by state or
federal authority. T his authority also allows the VA to treat veterans not enrolled in the VA health care system. Unless
another federal agency reimburses the VA, individuals could be charged for this care. “ [I]ndividuals who receive
hospital care or medical services under this section [38 C.F.R. §17.86] are responsible for the cost of the hospital care
or medical services when charges are mandated by Federal law (including applicable appropriation acts) or when the
cost of care or services is not reimbursed by other-than-VA Federal departments or agencies.” 38 C.F.R. §17.86.
288 Medical counter measures are “are life-saving medicines and medical supplies regulated by the U.S. Food and Drug
Administration (FDA) that can be used to diagnose, prevent, protect from, or treat conditions associated with chemical,
biological, radiological, or nuclear (CBRN) threats, emerging infectious diseases, or a natural disaster”
(https://www.cdc.gov/cpr/readiness/mcm.html); see CRS Report R46427, Developm ent and Regulation of Medical
Counterm easures for COVID-19 (Vaccines, Diagnostics, and Treatm ents): Frequently Asked Questions.
289 5 U.S.C. §7901; also see Appendix A of Department of Veterans Affairs, Veterans Health Administration, All-
Hazards Em ergency Cache Program , VHA Directive 1047, Washington, DC, April 21 , 2020, pp. A-1-A-2.
290 Defense Health Agency, “Patients by Beneficiary Category,” accessed March 19, 2021, https://www.health.mil/I-
Am-A/Media/Media-Center/Patient -Population-Statistics/Patients-by-Beneficiary-Category.
291 For more on the Military Health System, see CRS In Focus IF10530, Defense Primer: Military Health System .
292 For more on T RICARE cost -sharing features, see Defense Health Agency, T RICARE Fact Sheet, TRICARE Costs
and Fees 2021, December 2020, https://tricare.mil/-/media/Files/T RICARE/Publications/Misc/Costs_Sheet_2021.pdf.
293 DOD generally follows CDC guidance on COVID-19 screening, testing, diagnosis, and treatment. For more on
DOD-specific clinical guidance, see DOD, “ DoD COVID-19 Practice Management Guide,” March 4, 2021,
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COVID-19 Testing: Frequently Asked Questions

certain MTFs or through TRICARE-authorized civilian heath care providers or laboratories. DOD
has 158 clinical laboratories (stand-alone or embedded at MTFs) worldwide with COVID-19
diagnostic capabilities and can support up to 300,000 tests per week.294
There are no out-of-pocket costs for MHS beneficiaries obtaining medical y necessary COVID-
19 tests. Pursuant to FFCRA Section 6006(a), DOD is required to waive al TRICARE cost-
sharing requirements related to COVID-19 testing, administration of the test, and related items
and services provided during an associated health care office, urgent care, or emergency
department visit for the duration of the declared public health emergency.295
In addition to COVID-19 diagnostic and serologic testing, DOD conducts asymptomatic
screening and ongoing surveil ance testing of certain active duty servicemembers to mitigate
potential impacts to national security or ongoing military operations. Servicemembers subjected
to mandatory surveil ance testing include those assigned to strategic and nuclear deterrence
positions, initial recruitment or accession training, and forward-deployed forces.296
Does FEMA Pay for COVID-19 Testing?
FEMA may provide financial assistance for certain costs incurred for COVID-19 testing. The
presidential declarations of emergency and major disaster for COVID-19 under the Stafford Act
specifical y authorized Public Assistance (PA) for Emergency Protective Measures.297 Under

https://www.health.mil/Reference-Center/T echnical-Documents/2021/03/04/DoD-COVID-19-Practice-Management-
Guide-Version-7.
294 Military Health System Communications Office, “ DOD continues to increase COVID-19 test capacity,” Health.mil
News, December 7, 2020, https://www.health.mil/News/Articles/2020/12/07/DOD-continues-to-increase-COVID-19-
test-capacity.
295 For more on DOD-specific requirements and appropriations included in the FFCRA, see CRS Report R46316,
Health Care Provisions in the Fam ilies First Coronavirus Response Act, P.L. 116 -127; and Defense Health Agency,
Decision Memorandum on TRICARE Implementation of the “Families First Coronavirus Response Act, April 7, 2020,
https://www.health.mil/Reference-Center/Publications/2020/04/07/TRICARE-Implementation-of-the-Families-First-
Coronavirus-Response-Act .
296 See Jim Garamone, “DOD Starts T iered COVID-19 T esting Process to Ensure Safety,” DOD News, April 22, 2020,
https://www.defense.gov/Explore/News/Article/Article/2160008/dod-starts-tiered-covid-19-testing-process-to-ensure-
safety/; DOD, “ Force Health Protection Guidance (Supplement 9) – Department of Defense Guidance for Deployment
and Redeployment of Individuals and Units during the Novel Coronavirus Disease 2019 Pandemic,” May 26, 2020,
https://media.defense.gov/2020/May/26/2002305748/-1/-1/1/FORCE-HEALT H-PROTECTION-GUIDANCE-
SUPPLEMENT -9.PDF; and DOD Memorandum, “ Force Health Protection (Supplement 15) – Department of Defense
Guidance for Coronavirus Disease 2019 Laboratory T esting Services,” January 1, 2021, https://www.whs.mil/Portals/
75/Coronavirus/
FHP%20Guidance%20(Supplement%2015)%20DoD%20Guidance%20for%20Coronavirus%20Disease%202019%20
Laboratory%20Testing%20Services.pdf?ver=QqAUZYPv1pNNnJ4Tod00lQ%3d%3d. Forward-deployed forces, also
called “forward presence,” refers to the positioning of military personnel and capabilities within or near a theater of
operation in order to “demonstrate national resolve, strengthen alliances, dissuade potential adversaries, and enhance
the ability to respond quickly to contingencies.” Forward-deployed forces are typically positioned in overseas locations.
For more on forward presence, see DOD, DOD Dictionary of Military and Associated T erms, updated January 2021, p.
88, https://www.jcs.mil/Portals/36/Documents/Doctrine/pubs/dictionary.pdf.
297 T he President issued an emergency declaration, and subsequently issued major disaster declarations for all 50 states,
five territories, the District of Columbia, and three tribes, authorizing Public Assistance (PA) for COVID -19 response
efforts. FEMA, “COVID-19 Disaster Declarations,” https://www.fema.gov/coronavirus/disaster-declarations (Stafford
Act Declarations as of April 9, 2021). Public Assistance (PA) provides grant assistance to state, tribal, territorial, a nd
local governments, as well as eligible private nonprofit organizations, for the costs of urgent response and long-term
recovery work following an emergency or major disaster declared under the Robert T . Stafford Disaster Relief and
Emergency Assistance Act (Stafford Act; P.L. 93-288, as amended; 42 U.S.C. §§5121 et seq.). For more information,
see CRS Report R46749, FEMA’s Public Assistance Program : A Prim er and Considerations for Congress, by Erica A.
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COVID-19 Testing: Frequently Asked Questions

these declarations, FEMA may reimburse costs incurred by state, local, territorial, and tribal
governments, as wel as eligible nonprofits, including nonprofit health care providers,
(collectively referred to as “PA Applicants”) while executing eligible emergency response work in
response to the COVID-19 pandemic. Under these declarations, PA Applicants may receive
reimbursement for certain emergency medical care costs directly related to the COVID-19
pandemic, including “triage and medical y necessary tests and diagnosis related to COVID-19
cases as wel as screening testing needed to safely open and operate eligible public facilities,
including schools.”298 Related eligible costs include, but are not limited to
 the costs of temporary and expanded medical facilities;
 overtime for budgeted medical staff treating COVID-19 patients;
 regular time and overtime for temporary and contracted staff for testing and
treatment of COVID-19 patients;
 training for individuals to administer tests;
 the purchase and delivery of specialized medical equipment, PPE, and durable
and consumable medical supplies;
 laboratory testing materials and test kits, including antigen tests;
 contracting for testing by a third party; and
 technology to register and track testing results.299
FEMA is to reimburse PA Applicants for 100% of eligible costs incurred from January 2020 to
December 31, 2021, while performing eligible work, including medical y necessary tests,
pursuant to the COVID-19 Stafford Act declarations.300 For example, U.S. Senators from Il inois
reported that FEMA had provided funds to the state for costs incurred from January 20, 2020,
through August 31, 2020, for COVID-19 test collection, among other expenses.301
FEMA may reimburse at least 75% of eligible costs after December 31, 2021; the agency intends
to provide 30 days’ notice before assistance may lapse.302

Lee.
298 FEMA, “Coronavirus (COVID-19) Pandemic: Medical Care Eligible for Public Assistance (Interim) (Version 2),”
FEMA Policy #104-21-0004, p. 4 (hereinafter FEMA, “ COVID-19: Eligible Medical Care”), https://www.fema.gov/
sites/default/files/documents/fema_public-assistance-covid-19-medical-care-v2-with-equity-job-aid_policy_3-15-
2021.pdf; FEMA, “ FEMA Funding for COVID-19 T esting,” August 28, 2021, https://www.fema.gov/fact -sheet/fema-
funding-covid-19-testing.
299 Eligibility for the costs of PPE and medical supplies are subject to disposition requirements. For a nonexclusive list
of eligible medical care costs and requirements, see FEMA, “ FEMA Funding for COVID-19 T esting,” August 28,
2021, https://www.fema.gov/fact-sheet/fema-funding-covid-19-testing.
300 FEMA, “FEMA, “COVID-19: Eligible Medical Care,” p. 4, https://www.fema.gov/sites/default/files/documents/
fema_public-assistance-covid-19-medical-care-v2-with-equity-job-aid_policy_3-15-2021.pdf; FEMA, “ Statement on
100% Cost Share,” February 7, 2021, https://www.fema.gov/press-release/20210203/fema-statement-100-cost-share;
and FEMA, “FEMA Funding for COVID-19 T esting,” August 28, 2021, https://www.fema.gov/fact-sheet/fema-
funding-covid-19-testing.
301 Sen. T ammy Duckworth, “Duckworth, Durbin Announce More T han $71 Million in FEMA Reimburseme nt
Funding for Illinois COVID-19 Response,” March 25, 2021, https://www.duckworth.senate.gov/news/press-releases/
duckworth-durbin-announce-more-than-71-mil-in-fema-reimbursement -for-il-covid-response. See also News 7
KWWL.com, “FEMA Awards Iowa with $78 million for COVID-19 Response,” May 7, 2020, https://kwwl.com/2020/
05/07/fema-awards-iowa-with-78-million-for-covid-19-response/. T he T estIowa website is available at
https://www.testiowa.com/en.
302 FEMA, “COVID-19: Eligible Medical Care,” p. 13.
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There is no predetermined limit on the amount of funding available through the PA program.303
However, FEMA wil not reimburse costs covered by another source, which may include private
or publicly funded insurance, funding provided through the CARES Act (P.L. 116-136), the
COVID-19 Uninsured Program for uninsured patients, or programs overseen by HHS, among
others.304 In addition, to be eligible for reimbursement, FEMA must confirm that costs are
reasonable.305 FEMA has advised it wil use Medicare rates as the basis to determine cost
reasonability for eligible medical care.306
PA is funded through the Disaster Relief Fund (DRF), the primary source of funding for the
federal government’s domestic general disaster relief programs.307 DRF appropriations are not
general y al ocated for specific emergencies, disasters, or forms of assistance, and may general y
be obligated for disasters past and present. FEMA reported that it obligated approximately $5.8
bil ion from the DRF for PA for the COVID-19 pandemic response in FY2020; the agency
estimates that it wil obligate approximately $35 bil ion in spending from the DRF for PA for
COVID-19 response costs in FY2021.308 FEMA reported that projected obligations in 2021 for
PA for the COVID-19 pandemic reflect, among other costs, the increased federal cost share from
75% to 100% in through December 31, 2021, as wel as costs for vaccine distribution, National
Guard activities, and reopening and safe operation of eligible facilities.309
Payment for Testing for Individuals with No Source
of Coverage
As mentioned above, some community-based testing and testing at some types of facilities may
be available to individuals who do not have a source of payment. The federal government has
created an uninsured fund that may reimburse facilities for testing provided to uninsured
individuals. In addition, Congress has enacted legislation that has expanded Medicaid eligibility
under limited circumstances so that Medicaid funds may be available for testing for some
uninsured individuals who are otherwise ineligible for Medicaid.

303 Stafford Act assistance is subject to the availability of funds in the Disaster Relief Fund.
304 FEMA, “COVID-19: Eligible Medical Care,” pp. 12-13; Stafford Act Section 312 (42 U.S.C. §5155) (Section 312
addresses duplication of benefits). T he HHS Uninsured Program fund is discussed in the “ How Can Facilities T hat
Provide T esting for Uninsured Individuals Be Reimbursed?” section of this report.
305 2 C.F.R. §200.404; FEMA, Public Assistance Program and Policy Guide (PAPPG), v. 3.1, April 2018, pp. 21-23,
https://www.fema.gov/sites/default/files/documents/fema_pappg-v3.1-archived_policy_5-4-2018.pdf; and FEMA,
“Public Assistance: Reasonable Cost Evaluation,” Job Aid, October 13, 2018, https://www.fema.gov/sites/default/files/
2020-07/fema_pa_reasonable-cost -evaluation-job-aid.pdf.
306 FEMA will use standard Medicare rates that do not include the 20% increase in COVID-19 Medicare Diagnosis-
Related Group (DRG) rates implemented by the CARES Act. FEMA, “COVID-19: Eligible Medical Care,” p. 10.
307 For more information, see CRS Report R45484, The Disaster Relief Fund: Overview and Issues, by William L.
Painter.
308 FEMA, “Disaster Relief Fund: Monthly Report as of March 31, 2021,” April 8, 2021, Fiscal Year 2021 Report to
Congress, p. 13, https://www.fema.gov/sites/default/files/documents/fema_april-2021-disaster-relief-fund-report.pdf.
309 See explanation in FEMA, “Disaster Relief Fund: Monthly Report as of February 28, 2021,” March 11, 2021, Fiscal
Year 2021 Report to Congress, p. 23, https://www.fema.gov/sites/default/files/documents/fema_mar-2021-disaster-
relief-fund-report.pdf; and FEMA, “ Disaster Relief Fund: Monthly Report as of March 31, 2021,” April 8, 2021, Fiscal
Year 2021 Report to Congress, p. 25, https://www.fema.gov/sites/default/files/documents/fema_april-2021-disaster-
relief-fund-report.pdf.
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How Can Facilities That Provide Testing for Uninsured Individuals
Be Reimbursed?
Various laws enacted in response to the COVID-19 pandemic provide reimbursement to providers
who offer testing to uninsured individuals. FFCRA provides $1 bil ion for testing of individuals
who are uninsured as defined in FFCRA.310 PPPHCEA supplements that appropriation with an
additional $1 bil ion for uninsured testing.311 The CARES Act appropriated $100 bil ion for
provider relief, termed the Provider Relief Fund (PRF), which was established “to reimburse,
through grants or other mechanisms, eligible health care providers for health care related
expenses or lost revenues that are attributable to coronavirus.”312 The fund was supplemented
twice—PPPHCEA provided an additional $75 bil ion for the PRF, and the Consolidated
Appropriations Act, 2021 (P.L. 116-260) provided an additional $3 bil ion for the fund.313 An
unspecified portion of this fund is being used to test, treat, and vaccinate the uninsured.314
Collectively the specifical y appropriated funds for testing and the PRF funds al ocated are being
termed the “Uninsured Fund,” which is being administered by HRSA.315 GAO analyzed COVID-
19 related spending and found that $10 bil ion was being al ocated for testing and treatment of the
uninsured, but that unal ocated PRF funds may supplement that al ocation if necessary.316 HHS
tracks the amount reimbursed for uninsured testing and treatment and reports that more than $5.5
bil ion has been reimbursed; this exceeds the amount that had been specifical y appropriated. 317
On May 25, 2021, the Biden Administration announced that it was al ocating $4.8 bil ion of
ARPA funds for uninsured testing.318
Entities that seek reimbursement for testing and related services from the Uninsured Fund must
comply with certain terms and conditions.319 For example, entities must register with the fund,
provide required information about the services provided and the patient the services were
provided to, agree to accept the Medicare rate as full payment, and may not seek cost-sharing
from individuals. For patients who were tested prior to the funds’ establishment, and for whom a
facility may have already sought reimbursement, the facility must agree to return the already
collected cost-sharing to individuals.320 Facilities are not required to seek reimbursement from

310 For more information, see CRS Report R46316, Health Care Provisions in the Families First Coronavirus Response
Act, P.L. 116-127, and HHS, HRSA, “ COVID-19 Claims Reimbursements to Health Care Providers and Facilities for
the T esting and T reatment of the Uninsured,” https://coviduninsuredclaim.linkhealth.com/.
311 CRS Report R46325, Fourth COVID-19 Relief Package (P.L. 116-139): In Brief
312 P.L. 116-136.
313 For information on the HHS Provider Relief Fund, see CRS Insight IN11438, The COVID-19 Health Care Provider
Relief Fund.
314 CRS Report R46353, COVID-19: Overview of FY2020 LHHS Supplemental Appropriations.
315 CRS Insight IN11526, COVID-19 and the Uninsured: Federal Funding Options to Pay Providers for Testing and
Treatm ent
316 U.S. Government Accountability Office, COVID-19: Sustained Federal Action Is Crucial as Pandemic Enters Its
Second Year, 21-387, March 2021, p, 60, https://www.gao.gov/assets/gao-21-387.pdf.
317 HHS, “HHS COVID-19 Funding: T reatment & T esting of t he Uninsured,” https://taggs.hhs.gov/Coronavirus/
Uninsured.
318 Department of Health and Human Services, “ HHS to Dedicate $4.8 Billion from the American Rescue Plan to
COVID19 T esting for the Uninsured,” press release, May 25, 2021, https://www.hhs.gov/about/news/2021/05/25/hhs-
to-dedicate-billions-from-the-american-rescue-plan-for-the-uninsured.html.
319 HHS, HRSA, “FFCRA Relief Fund Payment T erms and Conditions,” https://www.hhs.gov/sites/default/files/terms-
and-conditions-ffcra-relief-fund.pdf.
320 HHS, HRSA, “COVID-19 Claims Reimbursements to Health Care Providers and Facilities for the T esting and
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COVID-19 Testing: Frequently Asked Questions

this fund, and they may provide care to individuals who are uninsured and seek payment from the
patient who received testing or treatment directly. If a facility does submit for reimbursement to
the Uninsured Fund, the fund would verify that the individual meets the FFCRA definition of
uninsured for purposes of uninsured testing. HRSA notes that individuals who have limited
Medicaid enrollment do not qualify for the uninsured testing fund, but would qualify for
uninsured treatment.321
Under What Circumstances Will Medicaid Pay for
Uninsured Testing?
Section 6004 of the FFCRA, as amended by the CARES Act, added, at state option, a new
Medicaid eligibility group (referred to as the “COVID-19 testing” eligibility group) to provide
testing and diagnosis of COVID-19, including testing-related services, testing-related visits and
the administration of the testing,322 without beneficiary cost-sharing (as required under Medicaid)
for certain specified uninsured individuals, beginning no earlier than March 18, 2020, through the
end of the COVID-19 public health emergency period, as specified. FFCRA provides a 100%
federal medical assistance percentage (FMAP or federal matching rate) for medical assistance and
administrative costs associated with Medicaid enrollees under this group, during such period.
FFCRA, as amended by the CARES Act, defines “uninsured individuals” as
 individuals who are not enrolled in another health care program funded by the
federal government, including CHIP, Basic Health Program (BHP), Medicare,
TRICARE and the VA, and federal employee health plans;
 individuals who are not enrolled in a group health plan or health insurance
coverage offered by a health insurance issuer (as defined in PHSA Section 2791),
including a qualified health plan through an exchange, employer-sponsored
health insurance, retiree health plans and Consolidated Omnibus Budget
Reconciliation Act (COBRA) continuation coverage;323
 individuals who are not eligible to receive coverage under one of Medicaid’s
existing mandatory eligibility groups (e.g., poverty-related children);
 individuals who would be eligible for Medicaid via the Affordable Care Act
(ACA, P.L. 111-148) Medicaid expansion pathway in states that have not adopted
this eligibility pathway (i.e., non-ACA Medicaid expansion states); and
 certain specified Medicaid enrollees who, by virtue of their Medicaid eligibility
pathway, are entitled to limited Medicaid benefits, including

T reatment of the Uninsured,” https://coviduninsuredclaim.linkhealth.com/.
321 HRSA, “Frequently Asked Questions for the COVID-19 Claims Reimbursement to Health Care Providers and
Facilities for T esting and T reatment of the Uninsured Program,” at https://www.hrsa.gov/coviduninsuredclaim/
frequently-asked-questions.
322 As with the new Medicaid mandatory coverage of in vitro diagnostic testing added under FFCRA, as amended by
the CARES Act, diagnostic and serological testin g may be covered for symptomatic and asymptomatic Medicaid
enrollees determined eligible via the “COVID-19 testing” pathway, as long as such tests are driven by medical
necessity. T o date, the Medicaid specific CMS guidance has not explicitly addressed the question of whether states can
use Medicaid as a payer of public health surveillance testing for SARS-CoV-2 (to screen for general health and safety).
323 CMS Medicaid FAQs. For questions about these types of private health insurance plans, congressional clients may
contact Vanessa C. Forsberg.
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 low-income tuberculosis-infected individuals who are entitled to services
related to the tuberculosis infection,
 individuals eligible only for family planning services and supplies,
 individuals eligible through the medical y needy pathway324 whose coverage
does not meet minimum essential health coverage,325 and
 certain low-income pregnant woman who are entitled to limited pregnancy-
related services.
While there is no income or resource test associated with the “COVID-19 testing” eligibility
pathway, applicants must be otherwise eligible for Medicaid (e.g., they must meet federal and
state requirements regarding residency, immigration status, and documentation of U.S.
citizenship). Like al other Medicaid eligibility pathways, applicants for the optional “COVID-19
testing” pathway are required to provide a Social Security number.326
COVID-19 testing without beneficiary cost-sharing for the “COVID-19 testing” eligibility group
is extended under Section 9811 of the ARPA for the period that begins on the date of enactment of
ARPA (i.e., March 11, 2021) and ends the last day of the first calendar quarter that begins one
year after the last day of the public health emergency period, as defined. However, regular FMAP
rates wil apply for such services with the sunset of the COVID-19 public health emergency
period.
Can the Uninsured Fund Reimburse Testing Provided to the
Optional Medicaid COVID-19 Testing Group?
Medicaid enrollees eligible through the optional “COVID-19 testing” group are not eligible for
coverage of COVID-19 testing and testing-related services through the HRSA-administered
COVID-19 Claims Reimbursement Program. In instances where an HRSA-administered COVID-
19 Claims Reimbursement Program pays a claim for COVID-19 testing or testing-related services
to a provider, but later determines that such services were delivered to a Medicaid enrollee
(regardless of that person’s Medicaid eligibility pathway), HRSA is required to recover
payment(s) made to the provider and to advise the provider to bil Medicaid as the primary
payer.327

324 Medically needy individuals (e.g., children, pregnant women, aged, blind, or disabled) are those who are otherwise
eligible for Medicaid but who have incomes too high to qualify and spend down their income on medical care. For this
medically needy subgroup, states may offer a more restrictive benefit package than is available to other enrollees.
325 For more information on the CMS crit eria used to evaluate whether a given state’s medically needy coverage meets
the minimum essential health coverage standard, see CMS, Dear State Health Official, Dear State Medicaid Director,
SHO# 14-002, Re: Minimum Essential Coverage, November 7, 2014, https://www.medicaid.gov/sites/default/files/
Federal-Policy-Guidance/downloads/SHO-14-002.pdf. For more general information on minimum essent ial coverage
under Medicaid, see https://www.medicaid.gov/medicaid/eligibility/minimum-essential-coverage/index.html.
326 42 C.F.R. §435.910.
327 Centers for Medicare & Medicaid Services, NEW FAQs- Released June 30, 2020, COVID-19 Frequently Asked
Questions (FAQs) for State Medicaid and Children’s Health Insurance Program (CHIP) Agencies, June 30, 2020,
https://www.medicaid.gov/state-resource-center/downloads/covid-19-new-faqs.pdf.
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How Can Individuals Who Are Unauthorized
Immigrants Obtain Testing?
Unauthorized (sometimes referred to as undocumented) immigrants are eligible to obtain testing
anywhere that COVID-19 testing is offered; for example, doctors’ offices, public health sites,
hospitals’ emergency departments, and community health centers.
Over half (55%) of the nonelderly328 unauthorized population in the United States has health
insurance.329 Nonelderly unauthorized immigrants who are uninsured can receive free or reduced-
cost testing at some of the aforementioned locations. Health care providers can seek
reimbursement through the HRSA-administered COVID-19 Claims Reimbursement Program.
HRSA has stated that “health care providers are not required to confirm immigration status prior
to submitting claims for reimbursement.”330
Under What Circumstances Will Medicaid Pay for Testing for
Unauthorized Immigrants?
With a few exceptions, state Medicaid programs are prohibited from covering unauthorized
immigrants.331 Under one such exception, emergency Medicaid, unauthorized immigrants who
are otherwise eligible for Medicaid except for their immigration status may receive “medical
assistance under Title XIX of the Social Security Act … for care and emergency services that are
necessary for the treatment of an emergency medical condition (as defined in Section 1903(v)(3)
of such Act) of the alien involved and are not related to an organ transplant procedure.”332
In response to the COVID-19 public health emergency, some states have extended coverage for
certain specified COVID-19-related health care expenses (e.g., testing) to otherwise eligible
unauthorized immigrants under emergency Medicaid.333 The duration and scope of COVID-19-
related emergency Medicaid coverage vary depending on the state.334

328 Individuals under the age of 65.
329 Samantha Artiga and Maria Diaz, “Healthcare Coverage and Care of Undocumented Immigrants,” Kaise r Family
Foundation, July 15, 2019, at https://www.kff.org/disparities-policy/issue-brief/health-coverage-and-care-of-
undocumented-immigrants/.
330 HRSA, “Frequently Asked Questions for the COVID-19 Claims Reimbursement to Health Care Providers and
Facilities for T esting and T reatment of the Uninsured Program,” at https://www.hrsa.gov/coviduninsuredclaim/
frequently-asked-questions.
331 T hese exceptions are (1) emergency Medicaid; (2) State Children’s Health Insurance Coverage (CHIP) coverage for
fetuses as permitted through federal regulation (often referred to as the CHIP unborn child pathway); and (3) the
CHIPRA option that allows states to provide Medicaid coverage to certain lawfully residing children and/or pregnant
women within the five-year waiting period when certain conditions are met. For more information, see CRS In Focus
IF11912, Noncitizen Eligibility for Medicaid and CHIP.
332 See Personal Responsibility and Work Opportunity Reconciliation Act of 1996 (PRWORA; P.L. 104-193),
§401(a)(1)(A).
333 For more information about states that are covering COVID-19 testing and treatment under emergency Medicaid,
see Jane Shubel, States are Leveraging Medicaid to Respond to COVID-19, Center on Budget and Policy Priorities,
June 18, 2020, https://www.cbpp.org/sites/default/files/atoms/files/5-7-20health.pdf#page=7.
334 For more information, see CRS Report R46339, Unauthorized Immigrants’ Eligibility for COVID-19 Relief
Benefits: In Brief.
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Also, on May 20, 2020, CMS approved two temporary Emergency Medicaid State Plan
Amendments (SPAs) in the Commonwealth of Northern Mariana Islands (CNMI). The first
permits CNMI to adopt the FFCRA “COVID-19 testing” eligibility pathway to extend COVID-19
testing without cost-sharing to uninsured individuals (as defined in FFCRA and as amended by
CARES), among other changes.335 The second al ows CMNI to extend full Medicaid coverage to
applicants whose attested gross income does not exceed 180% of the SSI federal benefit rate, and
al ows specified entities to make eligibility determinations regardless of an applicant’s
immigration status.336 This is done by using the presumptive eligibility Medicaid enrollment
facilitation tool to relax requirements regarding citizenship documentation. This SPA temporarily
extends full Medicaid (or eligibility for the COVID-19 testing group, as the case may be) to
unauthorized immigrants outside of emergency Medicaid and is in place from April 1, 2020,
through the end of the public health emergency, including any extensions.
Emergency Supplemental Funding for Testing
During the COVID-19 pandemic, given the role of testing as both a clinical care function and as a
part of disease control and response efforts, different types of tests have been provided in a
number of different settings. This includes the direct provision of diagnostic tests in traditional
health care settings, the provision of testing in community-based and other less traditional settings
for both screening and diagnostic purposes, and the provision of public health testing outside of
the clinical context. Further, testing has been expanded at scale to meet both clinical and public
health needs. As described above, the testing supply chain has been under stress, as has the
capacity of clinical laboratories, health care providers, and public health agencies to carry out
necessary testing. To help address these issues, Congress and the President have appropriated
emergency supplemental FY2020 and FY2021 funding to be used to support developing testing
infrastructure and capacity and for the clinical provision of tests. The two questions below discuss
examples of these types of funding sources separately; however, this distinction is not always
clear-cut, as some funding mechanisms could be used for testing capacity and infrastructure and
to pay for testing of individuals.
What Funds Have Been Appropriated for Testing Capacity and
Infrastructure?
Recently enacted appropriations in COVID-19 relief laws have included many appropriations that
can be used to support COVID-19 testing capacity and infrastructure. Testing capacity and
infrastructure are defined here as activities and functions intended to help provide COVID-19
testing at scale to help control the spread of the virus. Such activities and functions can include
increasing laboratory capacity (facilities, equipment, and workforce); procuring testing supplies
and improving supply chains; establishing and supporting community-based testing sites; and
supporting public health testing programs. (The following does not focus specifical y on
appropriations that support test-related research and development, manufacturing or regulation,

335 T he Commonwealth of the Northern Mariana Islands (CNMI) emergency Medicaid state plan amendment is
available at https://www.medicaid.gov/sites/default/files/State-resource-center/Medicaid-State-Plan-Amendments/
Downloads/CNMI/MP-20-0001.pdf.
336 T he Commonwealth of the Northern Mariana Islands (CNMI) emergency Medicaid state plan amendment is
available at https://www.medicaid.gov/State-resource-cent er/Medicaid-State-Plan-Amendments/Downloads/CNMI/
MP-20-0001-B.pdf.
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though these activities also have implications for testing capacity and some of the below listed
appropriations may also be used for those purposes.)
While many accounts across the federal government can support activities related to testing
capacity and infrastructure, the following major appropriations (greater than $20 bil ion dollars
each) were specifical y directed in the COVID-19 relief laws to, in large part, aid in expanding
testing capacity and infrastructure (al of which were either appropriated or have been budgeted to
the HHS Public Health and Social Services Emergency Fund account):337
Paycheck Protection Program and Health Care Enhancement Act (PPPHCEA; P.L. 116-139,
Division B, Title I) provided $25 bil ion total and directed HHS to reserve or transfer some of
these funds for specific purposes. For example, not less than $11 bil ion was for states, localities,
territories, tribes, tribal organizations (SLTT), urban Indian health organizations, and health
service providers to tribes. Of this total for SLTT grantees, not less than $2 bil ion was to be
al ocated according to the formula that applied to the Public Health Emergency Preparedness
(PHEP) cooperative agreement in 2019,338 and $4.25 bil ion was to be al ocated according to a
formula that is based on the relative number of COVID-19 cases. In addition, $750 mil ion of the
total for SLTT was to be al ocated in coordination with the IHS Director to tribes, tribal
organizations, urban Indian health organizations, or health service providers to tribes. In addition,
the law specified that certain amounts of these funds were to be transferred to other HHS
agencies, including not less than $1 bil ion to CDC for “surveil ance, epidemiology, laboratory
capacity expansion, contact tracing, public health data surveil ance and analytics infrastructure
modernization, disseminating information about testing, and workforce support necessary to
expand and improve COVID–19 testing.”339 The remaining funds were authorized to be used for
notably broad activities to boost testing infrastructure, production, capacity, and administration,
including for the purchase of testing supplies; for “construction, alteration, renovation, or
equipping of non-federal y owned facilities for the production of diagnostic, serologic, or other
COVID–19 tests”340 and “for grants for the rent, lease, purchase, acquisition, construction,
alteration, renovation, or equipping of non-federal y owned facilities to improve preparedness and
response capability at the state and local level for diagnostic, serologic, or other COVID–19
tests.”341
Consolidated Appropriations Act, 2021 (P.L. 116-260; Division M) provided a total of $22.4
bil ion. The law directed that funds shal be for SLTT entities, and that funding may be awarded
as grants or cooperative agreements. Of the total, $790 mil ion was designated as a transfer to
IHS, and a separate amount of not less than $2.5 bil ion was directed for “strategies for improving
testing capabilities and other purposes ... in high-risk and underserved populations, including
racial and ethnic minority populations and rural communities as wel as identifying best practices

337 T he PHSSEF account receives annual appropriations for the routine operations of several HHS offices, including the
Office of the HHS Assistant Secretary for Preparedness and Response (ASPR), the lead office for health emergency
preparedness and response strategy. T his account is also used for one-time or short -term funding, such as emergency
supplemental appropriations. Of the appropriations listed, PPPHCEA and Consolidated Appropriati ons Act provided
the appropriations directly to the PHSSEF account , while funds from ARPA (an authorizing measure) were budgeted
into the PHSSEF account according to HHS budget documents. See HHS, Fiscal Year 2022: Budget in Brief,
https://www.hhs.gov/sites/default/files/fy-2022-budget-in-brief.pdf, p. 22.
338 T he Public Health Emergency Preparedness (PHEP) cooperative agreement is a grant program that provides annual
funding to 62 state, territorial, and local grantees. It is authorized by Public Health Service Act, §319C-1 [42 U.S.C.
§247d–3a].
339 134 Stat. 624.
340 134 Stat. 625.
341 Ibid.
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for states and public health officials to use for contact tracing in high-risk and underserved
populations, including racial and ethnic minority populations and rural communities.”342 The
funding, except for the transfer to IHS, was directed to be awarded according to the formula that
applied to the PHEP cooperative agreement in FY2020.
American Rescue Plan Act of 2021 (ARPA, P.L. 117-2, Title II, Section 2401) provided a total
of $47.8 bil ion to the HHS Secretary, to remain available until expended, to carry out activities to
detect, diagnose, trace, and monitor SARS–CoV–2 (the virus that causes COVID-19) and
COVID-19 infections, and related strategies to mitigate the spread of COVID-19. The law
directed funds to carry out the following pandemic response activities: (1) implement a national
testing, contact tracing, surveil ance, and mitigation strategy; (2) provide grant or cooperative
agreement funding and technical guidance to SLTT public health departments for this effort; (3)
support the development, manufacture, procurement, and distribution of supplies necessary for
administering tests (e.g., PPE), and the acquisition, construction, renovation, or alteration of
nonfederal sites used for the production of COVID-19 tests and related supplies; (4) invest in
improving laboratory and contact tracing capacity, including through academic and research labs,
community testing sites and organizations, and mobile testing services, as wel as investments
with respect to quarantine and isolation of contacts; (5) support public health data sharing through
information technology, data modernization, and reporting; (6) provide grants to SLTT to improve
the public health workforce; and (7) cover administrative and program support costs. The
provision did not specify how much of the total appropriation is to be awarded as SLTT grants or
cooperative agreements, and general y gives discretion to the HHS Secretary to determine SLTT
award amounts.
Aside from the above major appropriations, several other HHS accounts received funding in
COVID-19 relief acts that could be al ocated towards testing capacity and infrastructure-related
purposes—for example, CDC supports SLTT public health laboratories and testing programs;
CDC received several broad appropriations for pandemic response that could be al ocated toward
related activities. ASPR also plays a role in procurement and distribution of testing supplies; other
appropriations to the PHSSEF account could also be used for related purposes by ASPR.343
Additional funding of $10 bil ion for Defense Production Act actions specific to medical supplies
(including those related to testing) was made available in ARPA (Title III, Section 3101), and
these funds have been budgeted to HHS.344
GAO reported that, as of May 31, 2021, HHS had al ocated $61.4 bil ion for testing capacity and
infrastructure-specific activities345 from al COVID-19 relief laws and obligated $21.2 bil ion of
that amount. This testing-specific total is in addition to other spending categories that have
supported testing programs, such as the SLTT public health grant category, which totaled $40.1

342 U.S. Congress, House Committee on Rules, Rules Committee Print 116-68 Text of the House Amendment to the
Senate Am endm ent to H.R. 133, committee print, 116th Cong., 2nd sess., December 21, 2021, p. 4561.
343 For an overview of supplemental appropriations in COVID-19 relief acts, see the following CRS reports: CRS
Report R46711, U.S. Public Health Service: COVID-19 Supplem ental Appropriations in the 116th Congress, and CRS
Report R46834, Am erican Rescue Plan Act of 2021 (P.L. 117 -2): Public Health, Medical Supply Chain, Health
Services, and Related Provisions.
344 T he HHS FY2022 budget shows the American Rescue Plan Act (ARPA) DPA appropriations as a new HHS
account. See HHS, Fiscal Year 2022: Budget in Brief, https://www.hhs.gov/sites/default/files/fy-2022-budget-in-
brief.pdf, p. 22.
345 T he GAO “testing” category includes “procurement and distribution of testing supplies, community -based testing
programs, testing in high-risk and underserved populations and Indian Health Services’ programs, implementing a
national strategy, CDC testing-related activities such as technical assistance, and other activities.”
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bil ion in al ocations and $25.1 in obligations (total includes grants for al public health purposes,
encompassing testing as wel as others such as vaccination programs).346
Outside of HHS, several federal agencies and departments have also supported activities related
to testing capacity and infrastructure. For example, many states and other jurisdictions have used
the Department of Treasury’s Coronavirus Relief Fund (CRF) funding from the CARES Act to
support testing-related activities.347 Additional CRF funds made available in ARPA can also
support SLTT testing activities.348 As discussed above, FEMA has supported several activities
related to testing capacity and infrastructure, including the procurement and distribution of related
supplies, as wel as supporting community-based testing sites through funding in the Disaster
Relief Fund (DRF).349 In addition, funding made available to the statutory DOD account for DPA-
related purposes in the CARES Act (P.L. 116-136) was used in smal part to support testing
supply related activities.350
What Funds Have Been Appropriated for the Clinical Provision
of Tests?
Congress has appropriated funding in each of the response measures for testing specific
populations. Some of this funding is for testing populations where the federal government directly
provides services (e.g., to veterans through the VHA), to test specific populations that might
otherwise lack access to testing (e.g., the uninsured), or to facilities to provide testing to
underserved populations (e.g., rural health clinic testing). Below are a few examples of these
types of appropriations:
Funds for Federal Health Program Testing: FFCRA included appropriations of $82 mil ion to
DOD for testing for Defense Health Program beneficiaries, $64 mil ion to IHS for testing the
agency’s beneficiaries, and $60 mil ion total to the VA for testing VA beneficiaries.351 Subsequent
response measures have also included appropriations to these agencies to test their service
populations.
Funds to Testing Specific Populations: FFCRA appropriated $1 bil ion for uninsured testing.
Subsequently, PPPHCEA included $1 bil ion for this purpose. The Biden Administration has also

346 GAO, COVID-19: Continued Attention Needed to Enhanced Federal Preparedness, Response, Service Delivery and
Program Integrity, GAO-21-551, July 2021, pp. 104-105, https://www.gao.gov/assets/gao-21-551.
347 GAO, COVID-19: Sustained Federal Action is Crucial as Pandemic Enters Its Second Year, GAO-21-387, March
31, 2021, pp. 94-95.
348 For eligible uses of Coronavirus Relief Fund (CRF) funding from ARPA see relevant guidance and other documents
at U.S. Department of T reasury, “Coronavirus State and Local Fiscal Recovery Funds,” https://home.treasury.gov/
policy-issues/coronavirus/assistance-for-state-local-and-tribal-governments/state-and-local-fiscal-recovery-funds.
349 FEMA’s COVID-19 Healthcare Resource Roadmap lists public health capacity activities related to testing as an
eligible use of funding from its Public Assistance program. See FEMA, “COVID-19 Healthcare Resource Roadmap
(Version 2.0),” July 28, 2021, https://www.fema.gov/sites/default/files/documents/fema_covid-19-healthcare-resource-
roadmap-version2.0_07-08-2021.pdf. For general information about the Disaster Relief Fund, see CRS Report R45484,
The Disaster Relief Fund: Overview and Issues.
350 One public announcement of a testing-related allocation of the DPA funding was on April 29, with $75 million for
nasal swab production. See CRS Insight IN11387, COVID-19: Defense Production Act (DPA) Developm ents and
Issues for Congress.
351 T his includes $30 million for testing at the VA and $30 million for testing through the Veterans Health
Administration’s Community Care program.
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al ocated $4.8 bil ion for uninsured testing drawn from the $47.8 bil ion appropriated in ARPA for
testing.
Funds for Testing at Specific Types of Facilities: Supplemental appropriations have been
provided for testing at specific types of nonfederal facilities. For example, $600 mil ion of the
amount appropriated to the PHSSEF in PPPHCEA was transferred to HRSA to support testing at
health centers. PPPHCEA also appropriated $225 mil ion for testing at rural health clinics , which
are smal outpatient facilities in rural areas.352
This discussion of specific funding appropriated for testing and testing related purposes does not
include the mandatory spending budgetary effects of clinical testing-related provisions carried in
COVID-19 response legislation. For example, FFCRA and the CARES Act included several
provisions to expand coverage of testing paid by federal health programs, such as Medicare and
Medicaid, as wel as private insurance. (These are covered in this report and in other CRS
reports.)353
Public Health Reporting of COVID-19 Test Data
What Types of Testing Data Are Collected?
CDC collects many types of data related to testing, some provided by states or other jurisdictions
and some provided directly by laboratories to CDC.354 These data are used to monitor public
health trends, understand the virus, and better understand disease trends and affected populations.
Existing testing-related surveil ance (i.e., data collection) systems include the following:
 Case-based surveillance. Positive COVID-19 test results are reported by
laboratories to jurisdictions that then link and collect detailed information on
each case, including demographic and health information. Jurisdictions use a case
reporting system to report to CDC.355 Case reporting occurs through CDC’s
National Notifiable Diseases Surveil ance System.356
 Virologic surveillance. CDC collects data on al COVID-19 diagnostic
laboratory test results through its COVID Electronic Laboratory Reporting
system, which collects data shared by over 1,000 laboratories with state and other
jurisdictions’ health departments with CDC. These data do not include
nonlaboratory or point-of-care test sites, and therefore reflect the majority, but
not al , of COVID-19 testing in the United States. Test result data al ow for
tracking infection rates over time, by location, and identifying groups of
individuals at higher risk for infection.357

352 HHS, HRSA, “HHS Providers $225 Million for COVID-19 T esting in Rural Communities,” https://www.hhs.gov/
about/news/2020/05/20/hhs-provides-225-million-for-covid19-testing-in-rural-communities.html.
353 See also CRS Report R46334, Selected Health Provisions in Title III of the CARES Act (P.L. 116 -136), and CRS
Report R46316, Health Care Provisions in the Fam ilies First Coronavirus Response Act, P.L. 116 -127.
354 CDC, CDC Activities and Initiatives Supporting the President’s Plan for Opening Up America Again , May 2020,
https://www.cdc.gov/coronavirus/2019-ncov/downloads/php/CDC-Activities-Initiatives-for-COVID-19-Response.pdf.
355 CDC, “Coronavirus Disease 2019: Reporting a Confirmed Case,” updated May 5, 2020, https://www.cdc.gov/
coronavirus/2019-ncov/php/reporting-pui.html.
356 CRS correspondence with CDC, May 6, 2020.
357 HHS Protect Data Hub, “National T esting,” last updated May 30, 2021, https://protect-public.hhs.gov/pages/
national-testing.
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 Genomic Surveillance. CDC uses multiple strategies to conduct genomic
surveil ance and identify and monitor variants, including the National SARA-
CoV-2 Strain Surveil ance system, partnerships with commercial diagnostic
laboratories, collaboration with universities, and supporting local health
jurisdictions’ detection and sequencing efforts.358
Traditional y, most public health data reporting requirements have been based in state law. States
or other jurisdictions can mandate that laboratories or health care providers report data related to
certain diseases to jurisdictions’ public health departments. States then voluntarily share de-
identified data with CDC as a part of national surveil ance.359 The CARES Act added new
authorities for the HHS Secretary related to COVID-19 testing data. Specifical y, Section 18115
of the CARES Act requires that every clinical laboratory that performs or analyzes a test intended
to detect or diagnose a possible case of COVID-19 report the test results to the HHS Secretary in
such form and manner, and at such timing and frequency, as the Secretary may prescribe until the
end of the Secretary’s Public Health Emergency declaration (PHSA §319) with respect to
COVID-19 or any extension of such declaration. The provision al ows the Secretary to decide
which laboratories must submit reports pursuant to that section and does not require the data be
made publicly available. In addition, funding has been made available through several COVID-19
relief acts, which can be used to facilitate data sharing between the public health and health care
sectors.
CDC can also form partnerships with specific jurisdictions, other federal agencies, and academic
and nonprofit research institutions for public health data, an approach taken with some of CDC’s
genomic surveil ance activities.360
What Are the Federal Testing Data Requirements, and Do They
Vary by Type or Purpose of the Test?
On January 8, 2021, HHS updated June 2020 guidance to implement Section 18115 of the
CARES Act. As a part of the guidance, the Secretary requires that al laboratories report data with
a minimum set of required elements to state, local, tribal or territorial public health departments
using existing reporting channels. 361 The minimum required data elements that must be reported
for each test include, among other things, test result, patient characteristics (e.g., age, race,
ethnicity, and sex), and geographic location (e.g., zip code and county). The guidance also
provides that public health departments should collect information about a patient’s address and

358 CDC, “Genomic Surveillance for SARS-CoV-2 Variants,” Updated April 2, 2021, https://www.cdc.gov/
coronavirus/2019-ncov/cases-updates/variant -surveillance.html.
359 Lawrence O. Gostin and Lindsay F. Wiley, “Chapter Nine: Surveillance and Public Health Research: Privacy,
Security, and Confidentiality of Personal Health Information,” in Public Health Law: Duty, Power, and Restraint, 3rd
ed. (University of California Press), pp. 303 -344.
360 CDC, “Coronavirus Disease 2019: SARS-CoV-2 Sequencing (SPHERES),” updated July 7, 2020,
https://www.cdc.gov/coronavirus/2019-ncov/covid-data/spheres.html?CDC_AA_refVal=
https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019 -ncov%2Fcases-updates%2Fspheres.html.
361 HHS “COVID-19 Pandemic Response, Laboratory Data Reporting: CARES Act Section 18115” guidance refers
only to reporting requirements to state and local public health departments; however, complementary CDC guidance
notes that “[t]hese data must be reported daily, within 24 hours of test completion, to the appropriate state, tribal, local,
or territorial public health department based on the individual’s residence.” See CDC, How to Report COVID-19
Laboratory Data, updated January 26, 2021, at https://www.cdc.gov/coronavirus/2019-ncov/lab/reporting-lab-
data.html#:~:text=Laboratories%20are%20not%20required%20to,with%20state%20law%20or%20policies).
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phone number (which would al ow for case investigation and contact tracing), but should not
share this information with CDC.362
The guidance gives laboratories several options for submitting the data.363 Health jurisdictions
governments then share data with CDC on a daily basis.364 Laboratories may submit through an
automated platform that shares data automatical y with jurisdictional authorities as wel as with
CDC.365 According to CDC, 100% of state and territorial jurisdictions (including al 50 states,
Washington DC, and five territorial jurisdictions) have converted to COVID-19 electronic
laboratory reporting, representing 100% of the total laboratory testing volume in the country, as
of April 21, 2021.366
CDC has clarified that al COVID-19 testing sites performing tests for diagnostic or screening
purposes—including molecular, antigen, and antibody testing—are to report positive and negative
test results to the respective health department within 24 hours of test completion per the HHS
guidance.367 Tests that are conducted for screening or diagnostic purposes should have results
reported to the individual who was tested and the respective public health department; however,
results of tests that are conducted for public health surveil ance purposes should not be reported
to the individual who was tested, and can be reported in aggregate to the respective health
jurisdiction upon request, strictly for public health surveil ance purposes.368
Some test types, in particular, have faced reporting chal enges—especial y antigen tests, which
have been referred to as “rapid tests” and which are more often carried out at the point of care
rather than in a centralized laboratory. In the months following the introduction of antigen tests in
summer 2020, states and other jurisdictions varied in terms of whether they grouped molecular
and antigen testing together in testing data, reported results for different test types separately, or
reported antigen test results at al . Given differences in use of antigen tests compared with
molecular tests, testing indicators that combine the two would lead to different overal testing
positivity rates than testing metrics that rely solely on molecular tests.369 GAO also reported in
January 2021 that overal antigen test reporting by states and other jurisdictions was incomplete;
therefore, HHS was not publicly reporting antigen test data and did not have plans to do so.
Though requirements are in place to report antigen test results mentioned above, many
institutions that conduct such tests for screening purposes—such as nursing homes, schools,
pharmacies, correctional facilities—do not have procedures or capabilities in place to report test
results to their respective health departments. HHS has thus far addressed the issue for nursing

362 HHS, “COVID-19 Pandemic Response, Laboratory Data Reporting: CARES Act Section 18115,” January 8, 2021,
https://www.hhs.gov/sites/default/files/covid-19-laboratory-data-reporting-guidance.pdf.
363 Ibid. Specifically, laboratories may use existing reporting systems, as required by state or local law or policy, or
may report through a state or regional health information exchange systems.
364 Ibid.
365 Association of Public Health Laboratories (APHL), “APHL AIMS P latform,” https://www.aphl.org/programs/
informatics/pages/aims_platform.aspx.
366 CDC, “COVID-19 Electronic Laboratory Reporting Implementation by State,” Updated April 20 , 2021,
https://www.cdc.gov/coronavirus/2019-ncov/lab/electronic-reporting-map.html; does not account for T ribal or local
jurisdictions outside of the District of Columbia.
367 CDC, “How to Report COVID-19 Laboratory Data,” updated January 26, 2021,
http://www.cdc.gov/coronavirus/2019-ncov/lab/reporting-lab-data.htlml.
368 CDC, “T esting Strategies for SARS-CoV-2,” updated March 11, 2021, https://www.cdc.gov/coronavirus/2019-
ncov/lab/resources/sars-cov2-testing-strategies.html#anchor_1615061534186.
369 T he COVID T racking Project, “The State of State Antigen T est Reporting,” October 19, 2020,
https://covidtracking.com/analysis-updates/antigen-testing-reporting.
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home data by facilitating data submission through a specific CDC data module used for nursing
home data.370 As of June 2021, HHS had not released similar guidance for other settings.
Looking ahead, newly introduced at-home diagnostic tests may present unique reporting
chal enges. These at-home tests are general y available over the counter or by provider
prescription, and some at-home tests can be completed by the patient at home without the need to
send specimens to a laboratory. CDC recommends that individuals report their results to their
health care provider, who is required to subsequently send results to their patient’s respective
health jurisdiction; alternatively, some at-home tests come with instructions on how to report
results directly to the patient’s health jurisdiction via an online or mobile application.371 FDA’s
guidance to manufacturers has recommended that at-home test design facilitate reporting results
to health authorities, and some EUAs for at-home tests have required manufacturers to develop
tools to facilitate reporting as a condition of the EUA (e.g., an online or mobile application).372
Stil , because these at-home tests require individuals, not institutions with legal obligations, to
report results, there may be concerns that results wil be underreported.
How Is Demographic Data on Individuals Who Have Been Tested
Reported, and What Issues Have Arisen?
States and other jurisdictions are usual y responsible for deciding what information to collect and
share with CDC.373 State and other jurisdictional law can constrain the data elements that can be
shared with the federal government.374 In the early stages of the pandemic, many jurisdictions
were not collecting and/or reporting patient demographic information in case and testing data,
such as on patients’ race and ethnicity.375 These reporting gaps owe to many factors. Throughout
the COVID-19 pandemic, many jurisdictions have faced issues with incomplete data from
laboratories. In many reported cases, testing data reported from laboratories were missing key
patient information needed to contact the patient and conduct contact tracing. After a positive test
result, public health departments follow up with patients and providers to obtain full details about
the case—a difficult and time-consuming task, especial y when jurisdictions experience a surge in
cases. In addition, many public health departments rely on records shared by health care entities,

370 U.S. Government Accountability Office, COVID-19: Critical Vaccine Distribution, Supply Chain, Program
Integrity, and Other Challenges Require Focused Federal Attention, January 28, 2021, https://files.gao.gov/reports/
GAO-21-265/index.html#appendix7.
371 CDC, “Self-T esting,” updated April 25, 2021, https://www.cdc.gov/coronavirus/2019-ncov/testing/self-testing.html?
CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019 -ncov%2Ftesting%2Fat -home-
testing.html.
372 FDA, “ Coronavirus (COVID-19) Update: FDA Posts New T emplate for At -Home and Over-the-Counter Diagnostic
T ests for Use in Non-Lab Settings, Such as Homes, Offices or Schools,” press release, July 29, 2020,
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-posts-new-template-home-
and-over-counter-diagnostic-tests-use-non, and Kelly Lewis Brezoczky, Lucira COVID-19 All-In-One Test Kit, FDA,
November 17, 2020, https://www.fda.gov/media/143810/download.
373 Lawrence O. Gostin and Lindsay F. Wiley, “Chapter Nine: Surveillance and Public Health Research: Privacy,
Security, and Confidentiality of Personal Health Information,” in Public Health Law: Duty, Power, and Restraint, 3rd
ed. (University of California Press), pp. 303 -344.
374 Partnership for Public Health Law, “Legal Issues Related to Sharing of Clinical Health Data with Public Health
Agencies,” April 2016, https://www.astho.org/Public-Policy/Public-Health-Law/Legal-Issues-Related-to-Sharing-
Clinical-Health-Data-with-Public-Health-Agencies/.
375 Kelly Servick, “‘Huge Hole’ in T esting Data Blurs Racial, Ethnic Disparities,” Science, July 17, 2020,
https://science.sciencemag.org/content/369/6501/237.
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such as laboratories. Laboratories, in particular, do not typical y collect demographic data related
to race/ethnicity. Patients may also be unwil ing to share such information with providers.376
As described above, guidance issued pursuant to the provision in the CARES Act changed federal
reporting requirements for jurisdictions, adding a requirement to report race/ethnicity with al test
results in June 2020. According to data from April 30, 2021, 50 states report COVID-19 cases and
deaths by race/ethnicity, and 7 states and DC report testing data (positive and negative results) by
race only.377 As of June 3, 2021, 62% of total cases reported to CDC included data on
race/ethnicity.378
Though data collection has somewhat increased, such missing data issues have hindered the
public health response and experts’ ability to maintain situational awareness. CDC and the federal
government are seeking to address data issues through several efforts, including its Data
Modernization Initiative and various taskforces for public health data strategies and policy
development.379

376 Darius T ahir, “Virus Hunters Rely on Faxes, Paper Records as More States Reopen,” Politico, May 10, 2020; and
Council of State and T erritorial Epidemiologists, Driving Public Health in the Fast Lane: The Urgent Need for a 21 st
Century Data Superhighway, September 2019, https://cdn.ymaws.com/www.cste.org/resource/resmgr/pdfs/pdfs2/
Driving_PH_Display.pdf.
377 Johns Hopkins University (JHU) Coronavirus Resource Center, “Racial Data T ransparency: States that have
Released COVID-19 Data by Race,” last viewed April 30, 2021, https://coronavirus.jhu.edu/data/racial-data-
transparency.
378 CRS Report R46588, Tracking COVID-19: U.S. Public Health Surveillance and Data.
379 Health IT .gov, “Public Health Data Systems T ask Force 2021,” last updated April 30, 2021,
https://www.healthit.gov/hitac/committees/public-health-data-systems-task-force-2021.
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Appendix A. Acronyms Used in This Report
Acronym
Definition
AACC
American Association for Clinical Chemistry
ABP
Alternative Benefit Plans
ACA
Patient Protection and Affordable Care Act
AIMS
APHL Informatics Messaging Services
APHL
Association of Public Health Laboratories
AMP
Association for Molecular Pathology
ARPA
American Rescue Plan Act
ASCM
Association for Supply Chain Management
ASM
American Society for Microbiology
ASPR
Assistant Secretary for Preparedness and Response
BHP
Basic Health Program
CARES Act
Coronavirus Aid, Relief, and Economic Security Act
CBTS
Community-Based Testing Sites
CDC
Centers for Disease Control and Prevention
CFR
Code of Federal Regulations
CHIP
Children’s Health Insurance Program
CLIA
Clinical Laboratory Improvement Amendments
CMS
Centers for Medicare & Medicaid Services
CNMI
Commonwealth of Northern Mariana Islands
COBRA
Consolidated Omnibus Budget Reconciliation Act
CRF
Coronavirus Relief Fund
DCIPHER
Data Col ation and Integration for Public Health Event Response
DOD
Department of Defense
DOL
Department of Labor
DPA
Defense Production Act
DRF
Disaster Relief Fund
EMTALA
Emergency Medical Treatment and Active Labor Act
EPSDT
Early and Periodic Screening, Diagnostic, and Treatment
EUA
Emergency Use Authorization
FAQ
Frequently Asked Questions
FDA
Food and Drug Administration
FEHB
Federal Employees Health Benefits Program
FEMA
Federal Emergency Management Agency
FFCRA
Families First Coronavirus Response Act
FMAP
Federal Medical Assistance Percentage
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Acronym
Definition
FQHC
Federal y Qualified Health Center
HHS
Department of Health and Human Services
HMO
Health Maintenance Organization
HRSA
Health Resources and Services Administration
IDRRRF
Infectious Disease Rapid Response Reserve Fund
IHCIA
Indian Health Care Improvement Act
IHS
Indian Health Service
IVD
In Vitro Diagnostics
LDT
Laboratory-Developed Test
LTCF
Long-Term Care Facility
LTSS
Long-Term Services and Support
MA
Medicare Advantage
MHS
Military Health Services
MOU
Memorandum of Understanding
MTF
Military Treatment Facility
NAIC
National Association of Insurance Commissioners
NCI
National Cancer Institute (of the National Institutes of Health)
NF
Nursing Facility
NGA
National Governors Association
NIH
National Institutes of Health
NNDS
National Notifiable Diseases Surveil ance System
OIG
Office of Inspector General (HHS)
OS
Office of the Secretary (HHS)
OTC
Over-the-Counter
PA
Public Assistance (FEMA)
PAPPG
Public Assistance Program and Policy Guide (FEMA)
PCR
Polymerase Chain Reaction
PHSA
Public Health Service Act
PHEP
Public Health Emergency Preparedness
PHSSEF
Public Health and Social Services Emergency Fund
POC
Point-of-Care
PPE
Personal Protection Equipment
PPPHCEA
Paycheck Protection Program and Health Care Enhancement Act
PRF
Provider Relief Fund
PRWORA
Personal Responsibility and Work Opportunity Reconciliation Act of 1996
RHC
Rural Health Clinic
RNA
Ribonucleic acid
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Acronym
Definition
SLTT
State, local, territorial, and tribal
SNF
Skil ed Nursing Facility
SNS
Strategic National Stockpile
SPA
State Plan Amendment
SPHERES
Sequencing for Public Health Emergency Response, Epidemiology, and
Surveil ance
SSA
Social Security Act
STLDI
Short-term, limited duration insurance
TTSI
Testing, Tracing, and Supported Isolation
USC
United States Code
VA
Department of Veterans Affairs
VHA
Veterans Health Administration
VTM
Viral Transport Media

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Appendix B. Policy Experts Table
Topic
Contact
Types of COVID-19 Testing and Their Uses
Amanda K. Sarata
Test Accuracy
Amanda K. Sarata
Testing Infrastructure, Capacity and Strategies
Amanda K. Sarata
Hassan Z. Sheikh
Testing Supply Chain
Amanda K. Sarata
Erica A. Lee
Priority for Testing Individuals
Kavya Sekar
Hassan Z. Sheikh
Role of Federal Emergency Management Agency in Testing: Infrastructure,
Erica A. Lee
Delivery and Payment
Role of Public Health Departments in Testing
Kavya Sekar
Hassan Z. Sheikh
Taylor R. Wyatt
Sarah Lister
Testing for Uninsured Individuals
Elayne J. Heisler
Testing Disparities
Taylor R. Wyatt
Bureau of Prison Health Care
Nathan James
Defense Health Care
Bryce H. P. Mendez
Alan Ott
Veterans Health Care
Sidath Viranga Panangala
Jared S. Sussman
Indian Health Service
Elayne J. Heisler
Taylor R. Wyatt
Medicaid and the State Children’s Health Insurance Program (CHIP)
Evelyne P. Baumrucker
Medicare
Jim Hahn
Private Health Insurance
Vanessa C. Forsberg
Private Health Insurance (Out of Network)
Noah D. Isserman
Private Health Insurance (Legal Issues)
Jennifer A. Staman
Funding for Testing
Kavya Sekar
Taylor R. Wyatt
Unauthorized Immigrants’ Access to Testing
Abigail F. Kolker
Use of Uninsured Fund for Testing
Elayne J. Heisler
Medicaid Funding for Testing Uninsured Individuals
Evelyne P. Baumrucker
Testing Data Reporting
Kavya Sekar
Taylor R. Wyatt
Sarah Lister
Resources on Testing
Kate M. Costin

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Appendix C. Additional Resources
Below are frequently cited resources related to COVID-19 testing in the United States. This
appendix includes selected federal, academic, and stakeholder resources available at the time of
this report’s publication. Federal agencies continue to update guidance to reflect the current
situation. Please note, this is not a comprehensive list of resources.
Data Repositories
Preliminary data reported by U.S. laboratories including commercial reference, public health, and
hospital; totals may include antibody data from some states.
Centers for Disease Control and Prevention (CDC)
 CDC COVID Data Tracker: United States Laboratory Testing, Testing and
Seroprevalence, updated regularly, https://www.cdc.gov/covid-data-tracker/
#testing
 Previous U.S. Viral Testing Data August 27, 2020, https://www.cdc.gov/
coronavirus/2019-ncov/cases-updates/previous-testing-in-us.html
Coronavirus Resource Center, John Hopkins University & Medicine
For a complete list of data contributors, visit https://github.com/CSSEGISandData/COVID-19/
blob/master/README.md
 COVID-19 Dashboard by the Center for Systems Science and Engineering
(CSSE) at Johns Hopkins University, updated regularly,
https://coronavirus.jhu.edu/map.html
 Johns Hopkins COVID-19 Testing Insights Initiative, updated regularly,
https://coronavirus.jhu.edu/testing
 Testing Trends Tool, updated regularly, https://coronavirus.jhu.edu/testing/
tracker/overview
 Al State Comparison of Testing Efforts, updated regularly,
https://coronavirus.jhu.edu/testing/states-comparison
 Daily State-by-State Testing Trends, updated regularly,
https://coronavirus.jhu.edu/testing/individual-states
 Which U.S. States Meet WHO Recommended Testing Criteria?, updated
regularly, https://coronavirus.jhu.edu/testing/testing-positivity
 International Comparison of Positivity Rates and Tests Per Capita, updated
regularly, https://coronavirus.jhu.edu/testing/international-comparison
 Racial Data Transparency: States that have released breakdowns of COVID-
19 data by race, updated regularly, https://coronavirus.jhu.edu/data/racial-
data-transparency
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Department of Health and Human Services (HHS) Guidance
Department of Health and Human Services (HHS)
 COVID-19 Pandemic Response, Laboratory Data Reporting: CARES Act
Section 18115, https://www.hhs.gov/sites/default/files/covid-19-laboratory-
data-reporting-guidance.pdf
 COVID-19 Guidance for Hospital Reporting and FAQs For Hospitals,
Hospital Laboratory, and Acute Care Facility Data Reporting,
https://www.hhs.gov/sites/default/files/covid-19-faqs-hospitals-hospital-
laboratory-acute-care-facility-data-reporting.pdf%3C
Centers for Disease Control and Prevention (CDC)
 CDC COVID-19 Search Guidance Documents, Testing, https://www.cdc.gov/
coronavirus/2019-ncov/communication/guidance-list.html?Sort=
Date%3A%3Adesc&Topic=Disease%20Information%20%3E%20Testing
 Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens
for COVID-19, https://www.cdc.gov/coronavirus/2019-ncov/lab/guidelines-
clinical-specimens.html
 Testing Guidelines for Nursing Homes, https://www.cdc.gov/coronavirus/
2019-ncov/hcp/nursing-homes-testing.html
 Interim Guidance on Testing Healthcare Personnel for SARS-CoV-2,
https://www.cdc.gov/coronavirus/2019-ncov/hcp/testing-healthcare-
personnel.html
 Interim Considerations for Institutions of Higher Education Administrators for
SARS-CoV-2 Testing, https://www.cdc.gov/coronavirus/2019-ncov/
community/colleges-universities/ihe-testing.html
 Interim Guidelines for COVID-19 Antibody Testing, https://www.cdc.gov/
coronavirus/2019-ncov/lab/resources/antibody-tests-guidelines.html
Centers for Medicare & Medicaid Services (CMS)
 Clinical Laboratory Improvement Amendments (CLIA) Laboratory Guidance
During COVID-19 Public Health Emergency, https://www.cms.gov/files/
document/qso-20-21-clia.pdf-0
 Frequently Asked Questions: SARS-CoV-2 Surveil ance Testing,
https://www.cms.gov/files/document/06-19-2020-frequently-asked-questions-
covid-surveil ance-testing.pdf
 Medicare Administrative Contractor (MAC) COVID-19 Test Pricing,
https://www.cms.gov/files/document/mac-covid-19-test-pricing.pdf
 COVID-19 Frequently Asked Questions (FAQs) for State Medicaid and
Children’s Health Insurance Program (CHIP) Agencies,
https://www.medicaid.gov/state-resource-center/downloads/covid-19-faqs.pdf
 Current emergencies, Coronavirus Disease 2019, updated regularly,
https://www.cms.gov/About-CMS/Agency-Information/Emergency/EPRO/
Current-Emergencies/Current-Emergencies-page
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 Coronavirus Disease 2019 (COVID-19) Guidance, Updated as new Center for
Consumer Information and Insurance Oversight guidance documents are
published, https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-
FAQs#COVID-19
Food and Drug Administration (FDA)
 Policy for Coronavirus Disease-2019 Tests During the Public Health
Emergency (Revised), May 2020, https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/policy-coronavirus-disease-2019-
tests-during-public-health-emergency-revised
 FAQs on Testing for SARS-CoV-2, https://www.fda.gov/medical-devices/
emergency-situations-medical-devices/faqs-testing-sars-cov-2
HHS, Department of Labor, and the Treasury
 FAQS about Families First Coronavirus Response Act and Coronavirus Aid,
Relief, and Economic Security Act Implementation Part 42, April 11, 2020,
https://www.cms.gov/files/document/FFCRA-Part-42-FAQs.pdf
 FAQS about Families First Coronavirus Response Act and Coronavirus Aid,
Relief, and Economic Security Act Implementation Part 43, June 23, 2020,
https://www.cms.gov/files/document/FFCRA-Part-43-FAQs.pdf
 Additional Policy and Regulatory Revisions in Response to the COVID-19
Public Health Emergency, 85 Federal Register 71142, November 6, 2020
 FAQS ABOUT FAMILIES FIRST CORONAVIRUS RESPONSE ACT AND
CORONAVIRUS AID, RELIEF, AND ECONOMIC SECURITY ACT
IMPLEMENTATION PART 44, February 26, 2021, https://www.cms.gov/files/
document/faqs-part-44.pdf
Federal COVID-19 Guidance (Non-HHS)
U.S. Equal Employment Opportunity Commission (EEOC)
 What You Should Know About COVID-19 and the ADA, the Rehabilitation
Act, and Other EEO Laws, https://www.eeoc.gov/wysk/what-you-should-
know-about-covid-19-and-ada-rehabilitation-act-and-other-eeo-laws
White House
Biden Administration
 National Strategy for the COVID-19 Response and Pandemic Preparedness,
January 2021, https://www.whitehouse.gov/wp-content/uploads/2021/01/
National-Strategy-for-the-COVID-19-Response-and-Pandemic-
Preparedness.pdf
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Trump Administration
 Testing Blueprint: Opening Up America Again, April 2020,
https://trumpwhitehouse.archives.gov/wp-content/uploads/2020/04/Testing-
Blueprint.pdf
 Testing Overview: Opening Up America Again, April 2020,
https://www.trumpwhitehouse.gov/wp-content/uploads/2020/04/Testing-
Overview-Final.pdf
 Guidance on Interpreting COVID-19 Test Results, May 6, 2020,
https://www.trumpwhitehouse.gov/wp-content/uploads/2020/05/Testing-
Guidance.pdf
 Addendum to the Testing Blueprint, June 2020,
https://www.trumpwhitehouse.gov/wp-content/uploads/2020/06/Addendum-
to-the-testing-blueprint-FINAL.pdf
Test Strategies
Centers for Disease Control and Prevention (CDC)
 SARS-CoV-2 Testing Strategy: Considerations for Non-Healthcare
Workplaces, https://www.cdc.gov/coronavirus/2019-ncov/community/
organizations/testing-non-healthcare-workplaces.html
 Testing Strategy for Coronavirus (COVID-19) in High-Density Critical
Infrastructure Workplaces after a COVID-19 Case is Identified,
https://www.cdc.gov/coronavirus/2019-ncov/community/worker-safety-
support/hd-testing.html
 COVID-19 Serology Surveil ance Strategy, https://www.cdc.gov/coronavirus/
2019-ncov/covid-data/serology-surveil ance/index.html
Department of Health and Human Services (HHS)
 Report to Congress: COVID-19 Strategic Testing Plan, May 24, 2020,
https://www.democrats.senate.gov/imo/media/doc/
COVID%20National%20Diagnostics%20Strategy%2005%2024%202020%20
v%20FINAL.pdf
National Academy of Medicine (NAM)
 COVID-19 Testing Strategies for Colleges and Universities, 2020,
https://www.nap.edu/catalog/26005/covid-19-testing-strategies-for-colleges-and-
universities
The Johns Hopkins Center for Health Security
 Developing a National Strategy for SARS-CoV-2 Serosurveys in the United
States, June 18, 2020, https://www.centerforhealthsecurity.org/our-work/
publications/developing-a-national-strategy-for-sars-cov-2-serosurveys-in-the-
united-states
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The John Hopkins Bloomberg School of Public Health
 A National Plan to Enable Comprehensive COVID-19 Case Finding and
Contact Tracing in the US, April 2020,
https://www.centerforhealthsecurity.org/our-work/pubs_archive/pubs-pdfs/
2020/200410-national-plan-to-contact-tracing.pdf
The Rockefeller Foundation
 National COVID-19 Testing and Tracing Action Plan,
https://www.rockefel erfoundation.org/national-covid-19-testing-and-tracing-
action-plan/
Relevant Reports and Other Resources
Centers for Disease Control and Prevention (CDC)
 Overview of Testing for SARS-CoV-2, https://www.cdc.gov/coronavirus/
2019-ncov/hcp/testing-overview.html
 Report to Congress on Paycheck Protection Program and Health Care
Enhancement Act Disaggregated Data on U.S. Coronavirus Disease 2019
(COVID-19) Testing, May 2020, https://www.help.senate.gov/imo/media/doc/
FY%202020%20CDC%20RTC%20on%20COVID-
19%20Testing%20Data%20-%20CDCfinalclean.pdf
 CDC Activities and Initiatives Supporting the COVID-19 Response and the
President’s Plan for Opening America Up Again, May 2020,
https://web.archive.org/web/20210119072805/https://www.cdc.gov/
coronavirus/2019-ncov/downloads/php/CDC-Activities-Initiatives-for-
COVID-19-Response.pdf
Centers for Medicare & Medicaid Services (CMS)
 Frequently Asked Questions: COVID-19 Testing at Skil ed Nursing Facilities/
Nursing Homes, August 5, 2020, https://www.cms.gov/files/document/covid-
faqs-snf-testing.pdf
Department of Health and Human Services (HHS)
 Coronavirus (COVID-19) Testing, updated regularly, https://www.hhs.gov/
coronavirus/testing/index.html
 Community-Based Testing Sites for COVID-19, updated regularly,
https://www.hhs.gov/coronavirus/community-based-testing-sites/index.html
Federal Emergency Management Agency (FEMA)
 Federal Support to Expand National Testing Capabilities, May 4, 2020,
https://www.fema.gov/fact-sheet/federal-support-expand-national-testing-
capabilities
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Food and Drug Administration (FDA)
 Independent Evaluations of COVID-19 Serological Tests, updated regularly,
https://open.fda.gov/apis/device/covid19serology/
Government Accountability Office (GAO)
 COVID-19: Continued Attention Needed to Enhanced Federal Preparedness,
Response, Service Delivery and Program Integrity, GAO-21-551, July 19, 2021,
https://files.gao.gov/reports/105035/index.html.
 COVID-19: In Nursing Homes: HHS Has Taken Steps in Response to Pandemic,
but Several GAO Recommendations Have Not Been Implemented, March 17,
2021, https://www.gao.gov/products/gao-21-402t
 COVID-19: Critical Vaccine Distribution, Supply Chain, Program Integrity, and
Other Chal enges Require Focused Federal Attention, January 28, 2021,
https://www.gao.gov/products/gao-21-265
 COVID-19: Urgent Actions Needed to Better Ensure an Effective Federal
Response, November 2020, https://www.gao.gov/assets/gao-21-191.pdf
 COVID-19: Federal Efforts Could Be Strengthened by Timely and Concerted
Actions, September 21, 2020, https://www.gao.gov/products/gao-20-701
 COVID-19: Opportunities to Improve Federal Response and Recovery Efforts,
June 25, 2020, https://www.gao.gov/products/GAO-20-625
National Academy of Medicine (NAM)
 Evaluating Data Types: A Guide for Decision Makers using Data to
Understand the Extent and Spread of COVID-19, 2020, https://www.nap.edu/
catalog/25826/evaluating-data-types-a-guide-for-decision-makers-using-data
 Rapid Expert Consultation on Critical Issues in Diagnostic Testing for the
COVID-19 Pandemic (November 9, 2020), 2020, https://www.nap.edu/
catalog/25984/rapid-expert-consultation-on-critical-issues-in-diagnostic-
testing-for-the-covid-19-pandemic-november-9-2020
 Rapid Expert Consultation on SARS-CoV-2 Laboratory Testing for the
COVID-19 Pandemic (April 8, 2020), 2020, https://www.nap.edu/catalog/
25775/rapid-expert-consultation-on-sars-cov-2-laboratory-testing-for-the-
covid-19-pandemic-april-8-2020

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Author Information

Amanda K. Sarata, Coordinator
Erica A. Lee
Specialist in Health Policy
Analyst in Emergency Management and Disaster

Recovery

Elayne J. Heisler, Coordinator
Bryce H. P. Mendez
Specialist in Health Services
Analyst in Defense Health Care Policy

Evelyne P. Baumrucker
Sidath Viranga Panangala
Specialist in Health Care Financing
Specialist in Veterans Policy

Kate M. Costin
Kavya Sekar
Research Librarian
Analyst in Health Policy

Vanessa C. Forsberg
Hassan Z. Sheikh
Analyst in Health Care Financing
Analyst in Public Health Emergency Management

Jim Hahn
Jennifer A. Staman
Specialist in Health Care Financing
Legislative Attorney

Noah D. Isserman
Jared S. Sussman
Analyst in Health Insurance and Financing
Analyst in Health Policy

Nathan James
Taylor R. Wyatt
Analyst in Crime Policy
Analyst in Public Health Emergency Management

Abigail F. Kolker

Analyst in Immigration Policy

Disclaimer
This document was prepared by the Congressional Research Service (CRS). CRS serves as nonpartisan
shared staff to congressional committees and Members of Congress. It operates solely at the behest of and
under the direction of Congress. Information in a CRS Report should n ot be relied upon for purposes other
than public understanding of information that has been provided by CRS to Members of Congress in
connection with CRS’s institutional role. CRS Reports, as a work of the United States Government, are not
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