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BENEFIT COVERAGE GUIDELINE – 2.04.518 SARS-CoV-2 Serology
(Antibody) Testing Effective Date: Nov. 1 2020 Last Revised: Oct.
22, 2020 Replaces: N/A
RELATED MEDICAL POLICIES: None
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POLICY CRITERIA | DOCUMENTATION REQUIREMENTS | CODING RELATED
INFORMATION | GUIDELINES REVIEW | REFERENCES | HISTORY
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Introduction
Two kinds of tests are available for COVID-19: viral tests1 and
antibody (serology) tests2.
• A viral test tells you if you have a current infection. • An
antibody test tells you if you had a previous infection.
“Viral tests1 check samples from your respiratory system (such
as swabs of the inside of the nose) to determine if you currently
have an infection with SARS-CoV-2, the virus that causes COVID-19.
”
”Antibody tests2 check your blood by looking for antibodies,
which can show if you had a past infection with the virus that
causes COVID-19. Antibodies are proteins that help fight off
infections and usually provide protection against getting that
disease again (immunity). Antibodies are disease specific. For
example, measles antibody will protect a person who is exposed
again to measles but will have no effect if the person is exposed
to mumps.”
Depending on the timing of the infection and of the test, an
antibody test may not identify antibodies in someone with a current
COVID-19 infection. Therefore, antibody tests should not be used as
the sole test to diagnose COVID-19. A viral test is necessary to
determine if you are currently infected.
COVID-19 antibody tests are covered for the purpose of
supporting a COVID-19 diagnosis. The Families First Coronavirus
Response Act (“FFCRA”)3 requires coverage of “in vitro diagnostic
tests” for COVID-19. Federal regulatory guidance notes that
antibody tests are used to detect antibodies against the SARS-CoV-2
virus, are intended for use in the diagnosis of the disease or
https://www.cdc.gov/coronavirus/2019-ncov/testing/diagnostic-testing.htmlhttps://www.cdc.gov/coronavirus/2019-ncov/testing/serology-overview.htmlhttps://www.cdc.gov/coronavirus/2019-ncov/testing/diagnostic-testing.htmlhttps://www.cdc.gov/coronavirus/2019-ncov/testing/serology-overview.html
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condition of having current or past infection with SARS-CoV-2,
the virus which causes COVID-19,” and references the U. S. Food and
Drugs Administration’s (FDA’s) opinion that serological tests
should not be used as the sole basis for diagnosis.4 These services
are to be provided “in accordance with accepted standards of
current medical practice.”5 The Centers for Disease Control (“CDC”)
has published standards describing how antibody tests are used for
the purposes of diagnosis.6,7
The purpose of this guideline is to describe the Plan’s process
to confirm that a serology test is used to support a diagnostic
test for COVID-19. The Plan covers antibody tests used to support
the diagnosis of the disease or condition of a patient. Testing
performed for other purposes, such as public surveillance, is not
covered. Tests performed on an inpatient basis are presumed to be
for diagnostic purposes. Tests performed on an outpatient basis
require confirmation that the test is for the diagnosis of the
disease or condition of a patient, as described below.
Note: The Introduction section is for your general knowledge and
is not to be taken as policy coverage criteria. The rest of the
policy uses specific words and concepts familiar to medical
professionals. It is intended for providers. A provider can be a
person, such as a doctor, nurse, psychologist, or dentist. A
provider also can be a place where medical care is given, like a
hospital, clinic, or lab. This policy informs them about when a
service may be covered.
Policy Coverage Criteria
Scope of Policy: Serological tests for SARS-CoV-2 performed in
an outpatient place of service
Testing Coverage Criteria Serology testing for current/active
infection with SARS-CoV-2
In accordance with Centers for Disease Control (“CDC”) Interim
Guidelines for COVID-19 Antibody Testing6 issued May 23, 2020 and
Overview of Testing for SARS-CoV-27 published on June 13, 2020:
Serologic testing can be offered as a method to support diagnosis
of acute COVID-19 illness for persons who present late. • For
persons who present 9-14 days after illness onset, serologic
testing can be offered in addition to recommended direct
detection methods such as polymerase chain reaction. This will
maximize sensitivity as the sensitivity of nucleic acid
detection
https://www.cdc.gov/coronavirus/2019-nCoV/hcp/clinical-criteria.html
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Testing Coverage Criteria is decreasing and serologic testing is
increasing during this time period.
Serologic testing should be offered as a method to help
establish a diagnosis when patients present with late complications
of COVID-19 illness, such as multisystem inflammatory syndrome in
children.
Please note the following: • “Serology assays do not typically
replace direct detection
methods as the primary tool for diagnosing an active SARS-CoV-2
infection.” 6 In addition, the U.S. Food and Drug Administration
(FDA) states that serological tests should not be “used as the sole
basis of diagnosis.”4 As such, serological tests will not be
covered when provided as the sole basis of diagnosis for current
infection with COVID-19.
• The Plan relies on the Centers of Disease Control (CDC) as the
source of accepted standard of medical practice for COVID-19
diagnostic testing.
Serology testing to determine past infection with SARS-CoV-2
Serology tests to determine immune status of an individual are
not covered because such testing is not in accordance with accepted
standards of current medical practice. Please note the following: •
The Plan relies on the Centers of Disease Control (CDC) as the
source of accepted standard of medical practice for COVID-19
diagnostic testing. CDC’s Overview of Testing for SARS-CoV-27
states: “It is currently not clear whether a positive serologic
test indicates immunity against SARS-CoV-2; serologic tests should
not be used at this time to determine if an individual is
immune.”
Documentation Requirements The patient’s medical records
submitted for review should document that coverage criteria are
met. The record should include the following: • Office visit notes
that contain the relevant history, physical and reason the test is
being ordered
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Documentation Requirements AND • Name of the antibody test being
performed AND • Documentation for how the test impacts the medical
management of the patient
Coding
Code Description CPT 0224U Antibody, severe acute respiratory
syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus
disease [COVID-19]), includes titer(s), when performed
86328 Immunoassay for infectious agent antibody(ies),
qualitative or semiquantitative, single step method (eg, reagent
strip); severe acute respiratory syndrome coronavirus 2
(SARS-CoV-2) (Coronavirus disease [COVID-19])
86413 Severe acute respiratory syndrome coronavirus 2
(SARS-CoV-2) (Coronavirus disease [COVID-19]) antibody,
quantitative
86769 Antibody; severe acute respiratory syndrome coronavirus 2
(SARS-CoV-2) (Coronavirus disease [COVID-19])
Note: CPT codes, descriptions and materials are copyrighted by
the American Medical Association (AMA). HCPCS codes, descriptions
and materials are copyrighted by Centers for Medicare Services
(CMS).
Related Information
Definition of Terms
Diagnostic Testing: Testing to identify current infection in
individuals that is performed when a person is displaying symptoms
of COVID-19, or when a person is not symptomatic but has been
recently exposed to SARS-CoV-2 (either a confirmed or suspected
case of COVID-19).
Screening Testing: Testing to identify persons who are not
exhibiting symptoms of COVID-19 and who have not had a known or
suspected exposure to SARS-CoV-2. Screening testing is used
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to identify persons who may be contagious so that measures can
be taken to prevent further transmission of the virus (eg, testing
of a skilled nursing facility, correctional facility, employer
testing employees, or schools testing students, faculty and
staff).
Surveillance Testing: Testing for public health surveillance is
an ongoing, systematic collection, analysis, and interpretation of
health-related data for planning, implementation, and evaluation of
public health practice. Surveillance testing for SARS-CoV-2 is used
to monitor community or population level infection and disease
rather than that of an individual, or to gain the incidence and
prevalence of disease. Surveillance testing results are returned in
aggregate to the requesting institution as the testing is performed
only on de-identified specimens. Surveillance testing is not used
to return a diagnostic test result to an individual or for
individual decision-making (eg, a public health department randomly
selects and samples a percentage of all persons in a city at
intervals to assess local infection rates and trends)
Source: Centers for Disease Control and Prevention (National
Center for Immunization and Respiratory Diseases (NCIRD), Division
of Viral Diseases) Updated September 4, 2020.
Guidelines Review
Background
The purpose of this guideline is to describe the process that
the Plan uses to determine if a service is a diagnostic test for
COVID-19 in compliance with the relevant sections of the Families
First Coronavirus Response Act (FFCRA)3, Coronavirus Aid, Relief,
and Economic Security (CARES) Act8, and FAQs on Frequently Asked
Questions (FAQ) on FFCRA and CARESCARES Act, Part 424.5.
The Plan relies on the Centers of Disease Control (CDC) as the
source of accepted standard of medical practice for COVID-19
diagnostic testing6,7.
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Practice Guidelines and Position Statements
Centers for Disease Control and Prevention (CDC)
Tests Used to Diagnose COVID-19
The CDC provides that two kinds of tests are available for
COVID-19: viral tests and antibody tests.7,9
• “A viral test tells you if you have a current infection.
• An antibody test tells you if you had a previous
infection.”
The CDC Website states:
“Viral tests1 check samples from your respiratory system (such
as swabs of the inside of the nose) to tell you if you currently
have an infection with SARS-CoV-2, the virus that causes
COVID-19.”1
”Antibody tests2 check your blood by looking for antibodies,
which can show if you had a past infection with the virus that
causes COVID-19. Antibodies are proteins that help fight off
infections and usually provide protection against getting that
disease again (immunity). Antibodies are disease specific. For
example, measles antibody will protect a person who is exposed
again to measles but will have no effect if the person is exposed
to mumps.”
Depending on when someone was infected and the timing of the
test, the test may not find antibodies in someone with a current
COVID-19 infection. Antibody tests should not be used to diagnose
COVID-19. To see if you are currently infected, you need a viral
test.1 Viral tests identify the virus in samples from your
respiratory system, such as swabs from the inside of your nose.
Families First Coronavirus Response Act (FFCRA)3
Section 6001 of FFCRA Enacted March 18, 2020
This section requires private health insurance to cover testing
for COVID-19 without imposing cost-sharing (eg, deductibles,
coinsurance, or copayments) for the duration of the public health
emergency declared on January 31, 2020. This coverage includes the
cost of administering such approved tests and related visits to
health care providers.
https://www.cdc.gov/coronavirus/2019-ncov/testing/diagnostic-testing.htmlhttps://www.cdc.gov/coronavirus/2019-ncov/testing/serology-overview.htmlhttps://www.cdc.gov/coronavirus/2019-ncov/testing/diagnostic-testing.html
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Coronavirus Aid, Relief, and Economic Security (CARES) Act8
Section 3201 of CARES Act Enacted March 27, 2020
This section expands the scope of available diagnostic testing
for COVID-19 (i.e., coronavirus disease 2019) that private health
insurance plans must cover. Specifically, it requires coverage of
tests that have not been approved by the U.S. Food and Drug
Administration (FDA) if:
• The developer of such a test requests, or intends to request,
emergency use authorization, unless such request is denied or is
not submitted within a reasonable time;
• The test is developed and authorized in a state that has
notified HHS that the state intends to review such tests; or
• HHS has issued guidance that such test is appropriate.
Frequently Asked Questions (FAQ) on FFCRA and CARES Act, Part
424.5
Issued on April 11, 2020, this set out frequently asked
questions (FAQs) regarding implementation of the Families First
Coronavirus Response Act (the FFCRA)3, the Coronavirus Aid, Relief,
and Economic Security Act (the CARES Act)8, and other health
coverage issues related to Coronavirus Disease 2019 (COVID-19).4,5
These FAQs answer questions from stakeholders to help individuals
understand the law and benefit from it, as intended.
FFCRA Enacted March 18, 20203
• Section 6001 generally requires that Plans must provide
services related to diagnostic testing for detection of SARS-CoV-2
or the diagnosis of COVID-19 from March 18, 2020 through applicable
emergency period.
• This coverage must be provided without cost-sharing, prior
authorization, or other medical management requirements.
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CARES Act Enacted March 27, 20208
• Section 3201 of CARES Act amended section 6001 of FFCRA to
include a broader range of diagnostic items and other services that
Plans must cover without cost-sharing, prior authorization (PA) or
medical management requirements.
Question 4 from FAQ4:
Do “in vitro diagnostic tests” described in section 6001(a)(1)
of the FFCRA, as amended by section 3201 of the CARES Act, include
serological tests for COVID-19?
Yes. Serological tests for COVID-19 are used to detect
antibodies against the SARS-CoV-2 virus, and are intended for use
in the diagnosis of the disease or condition of having current or
past infection with SARS-CoV-2, the virus which causes COVID-19.
The Food and Drug Administration (FDA) currently believes such
tests should not be used as the sole basis for diagnosis. FDA has
advised the Departments that serological tests for COVID-19 meet
the definition of an in vitro diagnostic product for the detection
of SARS-CoV-2 or the diagnosis of COVID-19. Therefore, plans and
issuers must provide coverage for a serological test for COVID-19
that otherwise meets the requirements of section 6001(a)(1) of the
FFCRA, as amended by section 3201 of the CARES Act.
Question 6 from FAQ5:
May a plan or issuer impose any cost-sharing requirements, prior
authorization requirements, or medical management requirements for
benefits that must be provided under section 6001(a) of the FFCRA,
as amended by section 3201 of the CARES Act?
No. Section 6001(a) of the FFCRA provides that plans and issuers
shall not impose any cost-sharing requirements (including
deductibles, copayments, and coinsurance), prior authorization
requirements, or other medical management requirements for these
items and services. These items and services must be covered
without cost sharing when medically appropriate for the individual,
as determined by the individual’s attending healthcare provider in
accordance with accepted standards of current medical practice.
Infectious Diseases Society of America (IDSA)10
In the Infectious Diseases Society of America Guidelines on the
Diagnosis of COVID-19 (published May 6, 2020) stated:
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“…an expert panel consisting of clinicians, medical
microbiologists and methodologists critically appraised the
COVID-19 diagnostic literature using Grading of Recommendations
Assessment, Development and Evaluation (GRADE) methodology to
assess the certainty of evidence. Per GRADE, recommendations are
categorized as “strong” or “conditional”. The word “recommend”
indicates strong recommendations and “suggest” implies conditional
recommendations” See Figure 1: IDSA Algorithm for SARS-CoV-2
Nucleic Acid Testing (below).
Association of Public Health Laboratories (APHL)11
Public Health Considerations Serologic Testing for COVID-19,
Version 1 May 7, 2019
In the document prepared by: Association of Public Health
Laboratories aphl.org and CSTE.org with funding from CDC, the
following information was provided:
https://www.aphl.org/https://www.cste.org/?
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Serologic assays have several important public health
applications in the current coronavirus disease (COVID-19)
response. Despite their importance, serologic assays do not replace
molecular methods as the primary tool for the diagnosis of acute or
active infection. One essential application is the use of
high-quality serologic test methods to estimate the prevalence of
past viral infection or estimate the cumulative incidence of
infection in the US population. Serologic testing can improve our
understanding of disease transmission patterns and data from
serologic surveys can be used to understand the proportion of
persons previously infected, among various populations.“
In order for these methods to be used effectively for both
population level studies and individual use scientists need more
data on the performance characteristics of these tests and the
human immune response to severe acute respiratory syndrome
coronavirus 2 (SARS-CoV-2) infection. This includes the persistence
and protection offered by antibodies. Without this information,
results from these methods cannot be properly interpreted.
With those caveats, potential public health applications
include:
• Determining how widespread COVID-19 infection has been in a
community or population to both understand the scale of the current
pandemic and in preparation for future vaccine development and
deployment.
• Identification of persons with an antibody response to serve
as convalescent plasma donors.
• Determining if a person had an immune response to SARS-CoV-2,
irrespective of whether they had symptoms or not. At this time
there are not enough data to determine whether or not an immune
response confers immunity or for how long.
• Until more evidence about protective immunity is available,
serologic test results should not be used to make staffing
decisions (return to work), decisions regarding the need for
personal protective equipment or need to discontinue social
distancing measures.
• If used in conjunction with other diagnostic tests and
clinical history etc. serologic tests may be used as part of the
testing algorithm to establish a diagnosis of COVID-19 and identify
probable cases.
The U.S. Food and Drug Administration (FDA)
On April 17, 2020, the FDA provided recommendations in a letter
to health care providers on the Use of Serological (Antibody) Tests
for COVID-19. The FDA recommended:
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• “Do not use serological (antibody) tests as the sole basis to
diagnose COVID-19 but instead as information about whether a person
may have been exposed. “12
Regulatory Status
The U.S. Food and Drug Administration (FDA) has issued emergency
use authorizations (EUAs), an authorization that is available to
certain products in a declared public health emergency, for certain
antibody tests. The FDA also has a policy of enforcement discretion
for certain laboratories certified under the Clinical Laboratory
Improvement Amendments (CLIA) provided by CMS for performing
high-complexity testing to develop and validate their own
serological tests, called laboratory-developed tests (LTDs).13 The
FDA does not generally regulate antibody tests that are used for
surveillance purposes only, where test results are not returned to
patients or healthcare providers.
While there is a small number of commercial serological tests
that have been granted EUAs, there are over a hundred serological
tests currently on the market, some of which have not been
validated or authorized by the FDA.14
References
1. Centers for Disease Control and Prevention. Testing for
COVID-19. Last updated May 10, 2020. Atlanta, GA. Available online:
https://www.cdc.gov/coronavirus/2019-ncov/testing/diagnostic-testing.html
Accessed October, 2020.
2. Centers for Disease Control and Prevention. Test for Past
Infection (Antibody Test). Last updated May 23, 2020. Atlanta, GA.
Available online at:
https://www.cdc.gov/coronavirus/2019-ncov/testing/serology-overview.html
Accessed October, 2020
3. Congress.gov H.R.6201 - Families First Coronavirus Response
Act, Section 6001. Enacted March 18, 2020. Washington, DC.
Available online at:
https://www.congress.gov/bill/116th-congress/house-bill/6201
Accessed October, 2020.
4. Centers for Medicare and Medicaid Services. FAQs About
Families First Coronavirus Response Act and Coronavirus Aid,
Relief, and Economic Security Act Implementation, Q4. Published
April 11, 2020. Baltimore, MD. Available online at:
https://www.cms.gov/files/document/FFCRA-Part-42-FAQs.pdf Accessed
October, 2020.
5. Centers for Medicare and Medicaid Services. FAQs About
Families First Coronavirus Response Act and Coronavirus Aid,
Relief, and Economic Security Act Implementation, Q6. Published
April 11, 2020. Baltimore, MD. Available online at:
https://www.cms.gov/files/document/FFCRA-Part-42-FAQs.pdf Accessed
October, 2020.
6. Centers for Disease Control and Prevention. Interim
Guidelines for COVID-19 Antibody Testing. Last updated May 23,
2020. Atlanta, GA. Available online:
https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antibody-tests-guidelines.html.
Accessed October, 2020.
7. Centers for Disease Control and Prevention. Overview of
Testing for SARS-CoV-2. Last updated June 13, 2020. Atlanta, GA.
Available online:
https://www.cdc.gov/coronavirus/2019-nCoV/hcp/clinical-criteria.html
Accessed October, 2020.
https://www.cdc.gov/coronavirus/2019-ncov/testing/diagnostic-testing.htmlhttps://www.cdc.gov/coronavirus/2019-ncov/testing/serology-overview.htmlhttps://www.congress.gov/bill/116th-congress/house-bill/6201https://www.cms.gov/files/document/FFCRA-Part-42-FAQs.pdfhttps://www.cms.gov/files/document/FFCRA-Part-42-FAQs.pdfhttps://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antibody-tests-guidelines.htmlhttps://www.cdc.gov/coronavirus/2019-nCoV/hcp/clinical-criteria.html
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Page | 12 of 13 ∞
8. Congress.gov H.R.748 - CARES Act, Section 3201. Enacted March
27, 2020. Washington, DC. Available online at:
https://www.congress.gov/bill/116th-congress/house-bill/748
Accessed October, 2020.
9. Centers for Disease Control and Prevention. Testing for
COVID-19. Last updated May 1, 2020. Atlanta, GA. Available online:
https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/testing.html.
Accessed October, 2020.
10. Infectious Diseases Society of America. IDSA. Infectious
Diseases Society of America Guidelines on the Diagnosis of
COVID-19. Updated May 6, 2020. Arlington, VA. Available online at:
https://www.idsociety.org/practice-guideline/covid-19-guideline-diagnostics/
Accessed October, 2020.
11. Association of Public Health Laboratories (APHL). Public
Health Considerations: Serologic Testing for COVID-19. Version 1.
Published May 7, 2020. Silver Spring, MD. Available online at:
https://www.aphl.org/programs/preparedness/crisis-management/documents/serologic-Testing-for-COVID-19.pdf
Accessed October, 2020.
12. U.S. Food and Drug Administration (FDA). Important
information on the use of serological (antibody) tests for
COVID-19-letter to health care providers. 4/17/2020. Silver Spring,
MD. Available online:
https://www.fda.gov/medical-devices/letters-health-care-providers/important-information-use-serological-antibody-tests-covid-19-letter-health-care-providers
Accessed October, 2020.
13. U.S. Food and Drug Administration (FDA). FDA Fact Sheet.
Antibody test oversight and use for COVID-19. May 4, 2020. Silver
Spring, MD. Available online:
https://www.fda.gov/media/137599/download Accessed October,
2020.
14. U.S. Food and Drug Administration (FDA). Insight into FDA’s
revised policy on antibody tests: prioritizing access and accuracy.
May 4, 2020. Silver Spring, MD. Available online:
https://www.fda.gov/news-events/fda-voices/insight-fdas-revised-policy-antibody-tests-prioritizing-access-and-accuracy
Accessed October, 2020.
15. Centers for Disease Control and Prevention. Interim Guidance
for Rapid Antigen Testing for SARS-CoV-2. Last updated September 4,
2020. Atlanta, GA. Available online:
https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antigen-tests-guidelines.html
Accessed October 2020.
History
Date Comments 05/27/20 New policy, approved May 26, 2020,
effective for dates of service on or after May 27,
2020. Add to Pathology / Laboratory section. Serology testing
may be considered medically necessary in the inpatient setting when
previous diagnostic testing was performed and the individual
exhibits acute illness. Use of serology testing alone is not
medically necessary to determine a COVID-19 diagnosis.
06/10/20 Interim Review, approved June 9, 2020, effective June
10, 2020. Coverage criteria modified in accordance with CDC interim
guidelines issued May 23, 2020, to include when used to support
diagnosis of acute COVID-19 illness for persons presenting 9-14
days after illness onset, and as a method to help establish a
diagnosis when patients present with late complications of COVID-19
illness, such as multisystem inflammatory syndrome in children.
07/01/20 Interim Review, approved June 18, 2020, effective July
1, 2020. Coverage criteria modified in accordance with CDC Interim
Guidelines issued May 23, 2020 and the FAQs About Families First
Coronavirus Response Act and Coronavirus Aid, Relief, and Economic
Security Act Implementation, Q4 & Q6, published April 11, 2020.
The Plan
https://www.congress.gov/bill/116th-congress/house-bill/748https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/testing.htmlhttps://www.idsociety.org/practice-guideline/covid-19-guideline-diagnostics/https://www.idsociety.org/practice-guideline/covid-19-guideline-diagnostics/https://www.aphl.org/programs/preparedness/crisis-management/documents/serologic-Testing-for-COVID-19.pdfhttps://www.aphl.org/programs/preparedness/crisis-management/documents/serologic-Testing-for-COVID-19.pdfhttps://www.fda.gov/medical-devices/letters-health-care-providers/important-information-use-serological-antibody-tests-covid-19-letter-health-care-providershttps://www.fda.gov/medical-devices/letters-health-care-providers/important-information-use-serological-antibody-tests-covid-19-letter-health-care-providershttps://www.fda.gov/media/137599/downloadhttps://www.fda.gov/news-events/fda-voices/insight-fdas-revised-policy-antibody-tests-prioritizing-access-and-accuracyhttps://www.fda.gov/news-events/fda-voices/insight-fdas-revised-policy-antibody-tests-prioritizing-access-and-accuracyhttps://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antigen-tests-guidelines.htmlhttps://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antigen-tests-guidelines.html
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Date Comments relies on the Centers of Disease Control (CDC) as
the source of accepted standard of medical practice for COVID-19
diagnostic testing and will cover serology testing for support in
diagnosing persons presenting late or patients with late
complications of COVID-19. Serology tests to determine immune
status of an individual are not covered. References, reorganized,
updated, and added.
07/01/20 Coding update. Added CPT code 0224U.
09/11/20 Coding update. Added CPT code 86413.
11/01/20 Interim Review, approved October 22, 2020. Added CDC
definitions of diagnostic, screening, and surveillance testing to
policy related information.
Disclaimer: This medical policy is a guide in evaluating the
medical necessity of a particular service or treatment. The Company
adopts policies after careful review of published peer-reviewed
scientific literature, national guidelines, and local standards of
practice. Since medical technology is constantly changing, the
Company reserves the right to review and update policies as
appropriate. Member contracts differ in their benefits. Always
consult the member benefit booklet or contact a member service
representative to determine coverage for a specific medical service
or supply. CPT codes, descriptions and materials are copyrighted by
the American Medical Association (AMA). ©2020 Premera All Rights
Reserved.
Scope: Medical policies are systematically developed guidelines
that serve as a resource for Company staff when determining
coverage for specific medical procedures, drugs, or devices.
Coverage for medical services is subject to the limits and
conditions of the member benefit plan. Members and their providers
should consult the member benefit booklet or contact a customer
service representative to determine whether there are any benefit
limitations applicable to this service or supply. This medical
policy does not apply to Medicare Advantage.
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Discrimination is Against the Law
Premera Blue Cross complies with applicable Federal civil rights
laws and does not discriminate on the basis of race, color,
national origin, age, disability, or sex. Premera does not exclude
people or treat them differently because of race, color, national
origin, age, disability or sex.
Premera: • Provides free aids and services to people with
disabilities to communicate
effectively with us, such as: • Qualified sign language
interpreters • Written information in other formats (large print,
audio, accessible
electronic formats, other formats) • Provides free language
services to people whose primary language is not
English, such as: • Qualified interpreters• Information written
in other languages
If you need these services, contact the Civil Rights
Coordinator.
If you believe that Premera has failed to provide these services
or discriminated in another way on the basis of race, color,
national origin, age, disability, or sex, you can file a grievance
with: Civil Rights Coordinator - Complaints and Appeals PO Box
91102, Seattle, WA 98111 Toll free 855-332-4535, Fax 425-918-5592,
TTY 800-842-5357 Email [email protected]
You can file a grievance in person or by mail, fax, or email. If
you need help filing a grievance, the Civil Rights Coordinator is
available to help you.
You can also file a civil rights complaint with the U.S.
Department of Health and Human Services, Office for Civil Rights,
electronically through the Office for Civil Rights Complaint
Portal, available at
https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone
at: U.S. Department of Health and Human Services 200 Independence
Avenue SW, Room 509F, HHH Building Washington, D.C. 20201,
1-800-368-1019, 800-537-7697 (TDD) Complaint forms are available at
http://www.hhs.gov/ocr/office/file/index.html.
Getting Help in Other Languages
This Notice has Important Information. This notice may have
important information about your application or coverage through
Premera Blue Cross. There may be key dates in this notice. You may
need to take action by certain deadlines to keep your health
coverage or help with costs. You have the right to get this
information and help in your language at no cost. Call 800-722-1471
(TTY: 800-842-5357).
አማሪኛ (Amharic): ይህ ማስታወቂያ አስፈላጊ መረጃ ይዟል። ይህ ማስታወቂያ ስለ ማመልከቻዎ ወይም
የ Premera Blue Cross ሽፋን አስፈላጊ መረጃ ሊኖረው ይችላል። በዚህ ማስታወቂያ ውስጥ ቁልፍ
ቀኖች ሊኖሩ ይችላሉ። የጤናን ሽፋንዎን ለመጠበቅና በአከፋፈል እርዳታ ለማግኘት በተውሰኑ የጊዜ ገደቦች
እርምጃ መውሰድ ይገባዎት ይሆናል። ይህን መረጃ እንዲያገኙ እና ያለምንም ክፍያ በቋንቋዎ እርዳታ እንዲያገኙ
መብት አለዎት።በስልክ ቁጥር 800-722-1471 (TTY: 800-842-5357) ይደውሉ።
( ةالعربي :(. امةھ ماتولعم اإلشعار ھذا يحوي
خالل من ھاعلي صولحلا تريد لتيا التغطيةلل أو ةصحيلاكطيتتغ لىع
اظلحفل نةعيم يخراوت في إجراء خاذتال تحتاج وقد .اإلشعار ھذا في
تكلفة أية بدتك دون بلغتك مساعدةوال تاوملالمع ھذه على ولحصال لك
يحق .800-722-1471 (TTY: 800-842-5357)
أو طلبك وصخصب مةمھ ماتوعلم عارشإلا ھذا ويحي قدةمھم يخراوت ھناك
تكون قد .Premera Blue Cross
اعدةمس تصلايفكالتال دفع فيبـ
.
Arabic
Oromoo (Cushite): Beeksisni kun odeeffannoo barbaachisaa qaba.
Beeksisti kun sagantaa yookan karaa Premera Blue Cross tiin
tajaajila keessan ilaalchisee odeeffannoo barbaachisaa qabaachuu
danda’a. Guyyaawwan murteessaa ta’an beeksisa kana keessatti
ilaalaa. Tarii kaffaltiidhaan deeggaramuuf yookan tajaajila fayyaa
keessaniif guyyaa dhumaa irratti wanti raawwattan jiraachuu
danda’a. Kaffaltii irraa bilisa haala ta’een afaan keessaniin
odeeffannoo argachuu fi deeggarsa argachuuf mirga ni qabaattu.
Lakkoofsa bilbilaa 800-722-1471 (TTY: 800-842-5357) tii
bilbilaa.
Français (French): Cet avis a d'importantes informations. Cet
avis peut avoir d'importantes informations sur votre demande ou la
couverture par l'intermédiaire de Premera Blue Cross. Le présent
avis peut contenir des dates clés. Vous devrez peut-être prendre
des mesures par certains délais pour maintenir votre couverture de
santé ou d'aide avec les coûts. Vous avez le droit d'obtenir cette
information et de l’aide dans votre langue à aucun coût. Appelez le
800-722-1471 (TTY: 800-842-5357).
Kreyòl ayisyen (Creole): Avi sila a gen Enfòmasyon Enpòtan
ladann. Avi sila a kapab genyen enfòmasyon enpòtan konsènan
aplikasyon w lan oswa konsènan kouvèti asirans lan atravè Premera
Blue Cross. Kapab genyen dat ki enpòtan nan avi sila a. Ou ka gen
pou pran kèk aksyon avan sèten dat limit pou ka kenbe kouvèti
asirans sante w la oswa pou yo ka ede w avèk depans yo. Se dwa w
pou resevwa enfòmasyon sa a ak asistans nan lang ou pale a, san ou
pa gen pou peye pou sa. Rele nan 800-722-1471 (TTY:
800-842-5357).
Deutsche (German): Diese Benachrichtigung enthält wichtige
Informationen. Diese Benachrichtigung enthält unter Umständen
wichtige Informationen bezüglich Ihres Antrags auf
Krankenversicherungsschutz durch Premera Blue Cross. Suchen Sie
nach eventuellen wichtigen Terminen in dieser Benachrichtigung. Sie
könnten bis zu bestimmten Stichtagen handeln müssen, um Ihren
Krankenversicherungsschutz oder Hilfe mit den Kosten zu behalten.
Sie haben das Recht, kostenlose Hilfe und Informationen in Ihrer
Sprache zu erhalten. Rufen Sie an unter 800-722-1471 (TTY:
800-842-5357).
Hmoob (Hmong): Tsab ntawv tshaj xo no muaj cov ntshiab lus tseem
ceeb. Tej zaum tsab ntawv tshaj xo no muaj cov ntsiab lus tseem
ceeb txog koj daim ntawv thov kev pab los yog koj qhov kev pab cuam
los ntawm Premera Blue Cross. Tej zaum muaj cov hnub tseem ceeb uas
sau rau hauv daim ntawv no. Tej zaum koj kuj yuav tau ua qee yam
uas peb kom koj ua tsis pub dhau cov caij nyoog uas teev tseg rau
hauv daim ntawv no mas koj thiaj yuav tau txais kev pab cuam kho
mob los yog kev pab them tej nqi kho mob ntawd. Koj muaj cai kom
lawv muab cov ntshiab lus no uas tau muab sau ua koj hom lus pub
dawb rau koj. Hu rau 800-722-1471 (TTY: 800-842-5357).
Iloko (Ilocano): Daytoy a Pakdaar ket naglaon iti Napateg nga
Impormasion. Daytoy a pakdaar mabalin nga adda ket naglaon iti
napateg nga impormasion maipanggep iti apliksayonyo wenno coverage
babaen iti Premera Blue Cross. Daytoy ket mabalin dagiti importante
a petsa iti daytoy a pakdaar. Mabalin nga adda rumbeng nga
aramidenyo nga addang sakbay dagiti partikular a naituding nga
aldaw tapno mapagtalinaedyo ti coverage ti salun-atyo wenno tulong
kadagiti gastos. Adda karbenganyo a mangala iti daytoy nga
impormasion ken tulong iti bukodyo a pagsasao nga awan ti
bayadanyo. Tumawag iti numero nga 800-722-1471 (TTY:
800-842-5357).
Italiano ( ):Questo avviso contiene informazioni importanti.
Questo avviso può contenere informazioni importanti sulla tua
domanda o copertura attraverso Premera Blue Cross. Potrebbero
esserci date chiave in questo avviso. Potrebbe essere necessario un
tuo intervento entro una scadenza determinata per consentirti di
mantenere la tua copertura o sovvenzione. Hai il diritto di
ottenere queste informazioni e assistenza nella tua lingua
gratuitamente. Chiama 800-722-1471 (TTY: 800-842-5357).
Italian
中文 (Chinese):本通知有重要的訊息。本通知可能有關於您透過 Premera Blue Cross
提交的申請或保險的重要訊息。本通知內可能有重要日期。您可能需要在截止日期
之前採取行動,以保留您的健康保險或者費用補貼。您有權利免費以您的母
語得到本訊息和幫助。請撥電話 800-722-1471 (TTY: 800-842-5357)。
037338 (07-2016)
https://www.hhs.gov/ocr/office/file/index.htmlhttps://ocrportal.hhs.gov/ocr/portal/lobby.jsfmailto:[email protected]
-
日本語 (Japanese):この通知には重要な情報が含まれています。この通知には、 Premera Blue
Crossの申請または補償範囲に関する重要な情報が含まれている場合があります。この通知に記載されている可能性がある重要な日付をご確認くだ
さい。健康保険や有料サポートを維持するには、特定の期日までに行動を
取らなければならない場合があります。ご希望の言語による情報とサポー
トが無料で提供されます。800-722-1471 (TTY: 800-842-5357)までお電話ください。
한국어 (Korean): 본 통지서에는 중요한 정보가 들어 있습니다 . 즉 이 통지서는 귀하의 신청에 관하여 그리고
Premera Blue Cross 를 통한 커버리지에 관한 정보를 포함하고 있을 수 있습니다 . 본 통지서에는 핵심이
되는 날짜들이 있을 수 있습니다. 귀하는 귀하의 건강 커버리지를 계속 유지하거나 비용을 절감하기 위해서 일정한 마감일까지
조치를 취해야 할 필요가 있을 수 있습니다 . 귀하는 이러한 정보와 도움을 귀하의 언어로 비용 부담없이 얻을 수 있는
권리가 있습니다 . 800-722-1471 (TTY: 800-842-5357) 로 전화하십시오 .
ລາວ (Lao): ແຈ້ງການນີ້ ນສໍ າຄັນ. ແຈ້ງການນີ້ອາດຈະມີ ນສໍ
າຄັນກ່ຽວກັບຄໍ າຮ້ອງສະ ກ ຫຼື ຄວາມຄຸ້ມຄອງປະກັນໄພຂອງທ່ານຜ່ານ Premera
Blue Cross. ອາດຈະມີ ນທີ າຄັນໃນແຈ້ງການນີ້. ທ່ານອາດຈະຈໍ າເປັ ນຕ້ອງດໍ
າເນີ ນການຕາມກໍ ານົດ ເວລາສະເພາະເພື່ອຮັກສາຄວາມຄຸ້ມຄອງປະກັນສຸຂະພາບ ຫຼື
ຄວາມຊ່ວຍເຫຼື ອເລື່ອງ າໃຊ້ າຍຂອງທ່ານໄວ້ . ທ່ານມີ ດໄດ້ ບຂໍ້ ນນີ້ ແລະ
ຄວາມຊ່ວຍເຫຼື ອເປັ ນພາສາ ຂອງທ່ານໂດຍບ່ໍ ເສຍຄ່າ. ໃຫ້ໂທຫາ 800-722-1471
(TTY: 800-842-5357).
ູຂໍ້
່
ສໍ ັ
ຈ
ໝ
ສິ
ັ
່
ວ
ຄ
ມ
ມູຮັ
ູມີ ມຂໍ້
ភាសាែខមរ ( ): ឹ
រងរបស់
Premera Blue Cross ។ របែហលជាមាន កាលបរ ិ ឆ ំខានេនៅកងេសចក
េសចកតជី ូ
ជាមានព័ ៌ ៉ ងសំ ់អពី ់ ៉ ប់
នដំ ងេនះមានព័ ី
តមានយា ខាន ំ ទរមងែបបបទ ឬការរា
ណ ត៌មានយ៉ា ំ ់ តងសខាន។ េសចក
េចទស ់ ន ុ ត
ណងេនះ។ អ វការបេញញសមតភាព ដលកណតៃថ ចបាស
កតាមរយៈ
ដំ ឹ នករបែហលជារតូ ច ថ ់ ំ ់ ងជាក់ ់
នដ
ន
ី ន
ូ
អ
ូ
ជ
ជ
ំណឹងេនះរបែហល
នានា េដើ ីនងរកសាទុ ៉ បរងស់ ុ ់ ក ឬរបាក់ ំ
អ
មប ឹ កការធានារា ខភាពរបស ជ
ធនកមានសិ ទទលព័ មានេនះ និ ំ យេនៅកុងភាសារបសទិ ួ ត៌ ងជ ននួ
ន
់ កេដាយម
អ
នអ
យេចញៃថល។ ួ
នអស
ន
ិ
លុ ើ ូ ូយេឡយ។ សមទ ទ រស័ព 800-722-1471 (TTY: 800-842-5357)។
Khmer
ਕਵਰਜ ਅਤ ਅਰਜੀ ਬਾਰ ਮਹ ਤਵਪਰਨ ਜਾਣਕਾਰੀ ਹ ਸਕਦੀ ਹ . ਇਸ ਨ ਿਜਸ ਜਵਚ
ਖਾਸ
ਤਾਰੀਖਾ ਹ ਸਕਦੀਆ ਹਨ. ਜੇਕਰ ਤਸੀ ਜਸਹਤ ਕਵਰਜ ਿਰਖਣੀ ਹਵ ਜਾ ਓਸ ਦੀ ਲਾਗਤ
ਜਿਵਚ ਮਦਦ ਦ ੇਇਛ ੁਕ ਹ ਤਾਂ ਤਹਾਨ ਅ ਤਮ ਤਾਰੀਖ਼ ਤ ਪਿਹਲਾਂ ਕੁ ਝ ਖਾਸ ਕਦਮ ਚ ਕਣ
ਦੀ ਲੜ ਹ ਸਕਦੀ ਹ ,ਤਹੁਾਨ ਮਫ਼ਤ ਿਵਚ ਤ ਆਪਣੀ ਭਾਸ਼ਾ ਿਵ ਚ ਜਾਣਕਾਰੀ ਅਤ ਮਦਦ ਪਾਪਤ
ਕਰਨ ਦਾ ਅਿਧਕਾਰ ਹ ,ਕਾਲ 800-722-1471 (TTY: 800-842-5357).
ਪ ਜਾਬੀ (Punjabi): ਇਸ ਨ ਿਟਸ ਿਵਚ ਖਾਸ ਜਾਣਕਾਰੀ ਹ. ਇਸ ਨ ਿਟਸ ਿਵਚ
Premera Blue Cross ਵਲ ਤੁਹਾਡੀ
ੰ
ੰ
ੇ ੇ ੇ ੱ ੂ ੋ ੈ ੋੋ ਂ ੁ ੇ ੱ ੋ ੇ ੱੱ ੁ ੱ ੂੁ ੱ ੇ ੱ ੇ ੍ਰ ੈ
ੋ ੰ ੂ ੱ ੁ ੋ ੋ ੈ ੰ
ੋ ੈ ੋ
(Farsi): فارسی فرم بارهدر ھمم اطالعات حاوی است ممکن يهمالعا اين.
ميباشد ھمم اطالعات یوحا يهمالعا اين
در ھمم ھای خيتار به باشد.پ رایبستاکنممماش زينهھ اختدپر در مککيا
تان بيمهوشش حقظ
Premera Blue Cross طريق از ماش مهبيوشش يا و تقاضا ای پ. يدماين
جهتو يهمالعا اين
حق شما. يدشاب داشته اجتياح صیاخ کارھای امانج برای صیمشخ ایھ
خيتار به تان، انیمدر ھای کسب برای .نماييد دريافت گانيرا ورط به ودخ
زبان به را کمک و اطالعات اين که داريد را اين
استم ) 5357-842-800 مارهباش ماست TTY انکاربر(800-722-1471 مارهش
با اطالعات .اييدنم برقرار
้
Polskie (Polish): To ogłoszenie może zawierać ważne informacje.
To ogłoszenie może
zawierać ważne informacje odnośnie Państwa wniosku lub zakresu
świadczeń poprzez Premera Blue Cross. Prosimy zwrócic uwagę na
kluczowe daty, które mogą być zawarte w tym ogłoszeniu aby nie
przekroczyć terminów w przypadku utrzymania polisy ubezpieczeniowej
lub pomocy związanej z kosztami. Macie Państwo prawo do bezpłatnej
informacji we własnym języku. Zadzwońcie pod 800-722-1471 (TTY:
800-842-5357).
Português (Portuguese): Este aviso contém informações
importantes. Este aviso poderá conter informações importantes a
respeito de sua aplicação ou cobertura por meio do Premera Blue
Cross. Poderão existir datas importantes neste aviso. Talvez seja
necessário que você tome providências dentro de determinados prazos
para manter sua cobertura de saúde ou ajuda de custos. Você tem o
direito de obter e sta informação e ajuda em seu idioma e sem
custos. Ligue para 800-722-1471 (TTY: 800-842-5357).
Română (Romanian): Prezenta notificare conține informații
importante. Această notificare poate conține informații importante
privind cererea sau acoperirea asigurării dumneavoastre de sănătate
prin Premera Blue Cross. Pot exista date cheie în această
notificare. Este posibil să fie nevoie să acționați până la anumite
termene limită pentru a vă menține acoperirea asigurării de
sănătate sau asistența privitoare la costuri. Aveți dreptul de a
obține gratuit aceste informații și ajutor în limba dumneavoastră.
Sunați la 800-722-1471 (TTY: 800-842-5357).
Pусский (Russian): Настоящее уведомление содержит важную
информацию. Это уведомление может содержать важную информацию о
вашем заявлении или страховом покрытии через Premera Blue Cross. В
настоящем уведомлении могут быть указаны ключевые даты. Вам,
возможно, потребуется принять меры к определенным предельным срокам
для сохранения страхового покрытия или помощи с расходами. Вы
имеете право на бесплатное получение этой информации и помощь на
вашем языке. Звоните по телефону 800-722-1471 (TTY:
800-842-5357).
Fa’asamoa (Samoan): Atonu ua iai i lenei fa’asilasilaga ni
fa’amatalaga e sili ona taua e tatau ona e malamalama i ai. O lenei
fa’asilasilaga o se fesoasoani e fa’amatala atili i ai i le tulaga
o le polokalame, Premera Blue Cross, ua e tau fia maua atu i ai.
Fa’amolemole, ia e iloilo fa’alelei i aso fa’apitoa olo’o iai i
lenei fa’asilasilaga taua. Masalo o le’a iai ni feau e tatau ona e
faia ao le’i aulia le aso ua ta’ua i lenei fa’asilasilaga ina ia e
iai pea ma maua fesoasoani mai ai i le polokalame a le Malo olo’o e
iai i ai. Olo’o iai iate oe le aia tatau e maua atu i lenei
fa’asilasilaga ma lenei fa’matalaga i legagana e te malamalama i ai
aunoa ma se togiga tupe. Vili atu i le telefoni 800-722-1471 (TTY:
800-842-5357).
Español ( ): Este Aviso contiene información importante. Es
posible que este aviso contenga información importante acerca de su
solicitud o cobertura a través de Premera Blue Cross. Es posible
que haya fechas clave en este
tiene derecho a recibir esta información y ayuda en su idioma
sin costo
aviso. Es posible que deba tomar alguna medida antes de
determinadas fechas para mantener su cobertura médica o ayuda con
los costos. Usted
alguno. Llame al 800-722-1471 (TTY: 800-842-5357).
Spanish
Tagalog (Tagalog): Ang Paunawa na ito ay naglalaman ng
mahalagang impormasyon. Ang paunawa na ito ay maaaring naglalaman
ng mahalagang impormasyon tungkol sa iyong aplikasyon o pagsakop sa
pamamagitan ng Premera Blue Cross. Maaaring may mga mahalagang
petsa dito sa paunawa. Maaring mangailangan ka na magsagawa ng
hakbang sa ilang mga itinakdang panahon upang mapanatili ang iyong
pagsakop sa kalusugan o tulong na walang gastos. May karapatan ka
na makakuha ng ganitong impormasyon at tulong sa iyong wika ng
walang gastos. Tumawag sa 800-722-1471 (TTY: 800-842-5357).
ไทย (Thai): ประกาศนมขอมลสาคญ
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Premera Blue Cross และอาจมกาหนดการในประกาศน คณอาจจะตอง
ดาเนนการภายในกาหนดระยะเวลาทแนนอนเพอจะรกษาการประกนสขภาพของคณหรอการชวยเหลอท
มคาใชจาย คณมสทธทจะไดรบขอมลและความชวยเหลอนในภาษาของคณโดยไม่มคาใชจาย
โทร 800-722-1471 (TTY: 800-842-5357)
้ี ี ้ ู ํ ั ้ี ี ้ ู ่ี ํ ั ่ี ั ั ื ัุ ุ ่ ี ํ ี ุ ้ํ ิ ํ ่ี ่
่ื ั ั ุ ุ ื ่ ื ่ีี ่ ้ ่ ุ ี ิ ิ ่ี ้ ั ้ ู ่ ื ้ี ุ ี ่ ้ ่
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Ваше звернення щодо страхувального покриття через Premera Blue
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У Вас є право на отримання цієї інформації та допомоги безкоштовно
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(TTY: 800-842-5357).
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hoặc hợp đồng bảo hiểm của quý vị qua chương trình Premera Blue
Cross. Xin xem ngày quan trọng trong thông báo này. Quý vị có thể
phải thực hiện theo thông báo đúng trong thời hạn để duy trì bảo
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miễn phí. Xin gọi số 800-722-1471 (TTY: 800-842-5357).