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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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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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 LifeWise Health Plan of Washington. Daytoy ket mabalin dagiti importante a petsa iti daytoy

(Arabic): ةالعربي 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 امةھ ماتولعم اراإلشع ھذا يحوي . أو طلبك وصخصب مةمھ اتمولعم عارشإلا ھذا ويحي قد

mangala iti daytoy nga impormasion ken tulong iti bukodyo a pagsasao nga اللخ من ھاعلي لوالحص تريد التي التغطية LifeWise Health Plan of Washington. قدawan ti bayadanyo. Tumawag iti numero nga 800-592-6804 (TTY: 800-842-5357).

على اظلحفل نةعيم يخراوت في إجراء التخاذ اجتحت قدو . اإلشعار ذاھ في مھمة يخراوت ھناك تكون ةدمساعوال تالوملمعا ھذه على ولحصال لك يحق .يفكالتال دفع في دةاعسملل أو يةحصلا تكطيتغ

فةلكت أية بدتك دون تكغلب (TTY: 800-842-5357) 6804-592-800بـصل ات .

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037336 (07-2016)

Italiano (Italian): Questo avviso contiene informazioni importanti. Questo avviso può contenere informazioni importanti sulla tua domanda o copertura attraverso LifeWise Health Plan of Washington. 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 800-592-6804 (TTY: 800-842-5357).

https://www.hhs.gov/ocr/office/file/index.htmlhttps://ocrportal.hhs.gov/ocr/portal/lobby.jsfmailto:AppealsDepartmentInquiries@LifeWiseHealth.com

้

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Washington. ອາດຈະມີ ນທີ າຄັນໃນແຈ້ງການນ້ີ . ທ່ານອາດຈະຈໍ າເປັ ນຕ້ອງດໍ າ ເນີ ນການຕາມກໍ ານົດເວລາສະເພາະເພື່ ອຮັກສາຄວາມຄຸ້ມຄອງປະກັນສຸຂະພາບ ຫຼື ຄວາມຊ່ວຍເຫຼື ອເລ່ື ອງຄ່າໃຊ້ າຍຂອງທ່ານໄວ້ . ທ່ານມີ ດໄດ້ ບຂໍ້ ນນ້ີ ແລະ ຄວາມ ວຍເຫຼື ອເປັ ນພາສາຂອງທ່ານໂດຍບໍ່ ເສຍຄ່າ. ໃຫ້ໂທຫາ 800-592-6804

(TTY: 800-842-5357).

ភាសាែខមរ (Khmer):

ມູ ຮັ ສິ

ມູ ຂໍ້

ສໍ

ຈ່

ວັ

ມູ ຂໍ້ ມີ ໝັ

ຊ່

Română (Romanian): Prezenta notificare conține informații importante. Această notificare poate conține informații importante privind cererea sau acoperirea asigurării dumneavoastre de sănătate prin LifeWise Health Plan of Washington. 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 800-592-6804 (TTY: 800-842-5357).

Pусский (Russian): Настоящее уведомление содержит важную информацию. Это уведомление может содержать важную информацию о вашем заявлении или страховом покрытии через LifeWise Health Plan of Washington. 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 800-592-6804 (TTY: 800-842-5357).

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Español (Spanish): Este Aviso contiene información importante. Es posible que este aviso contenga información importante acerca de su solicitud o cobertura a través de LifeWise Health Plan of Washington. Es posible que haya fechas clave en este aviso. Es posible que deba tomar alguna medida antes de

េសចកតជី ូ នដំ ងេនះមានព័ ី

ជាមានព័ ៌ ៉ ងសំ ់អពី ់ ៉ ប់ តមានយា ខាន ំ ទរមងែបបបទ ឬការរា

ជូ ត៌ ណឹ នដ

រងរបស់អន

LifeWise Health Plan of Washington ។ របែហលជាមាន កាលបរ ិ ឆ ំ ់ េចទសខានេនៅ

មានយ៉ា ំ ់ ត ងសខាន។ េសចក ំណឹងេនះរបែហល

កតាមរយៈ

ងេសចកត ី នដណងេនះ។ អករបែហលជារតវការបេញញសមតភាព ដល់ ណត់ ំ ឹ ន ូ ច ថ កំ ជូ កន ុ determinadas fechas para mantener su cobertura médica o ayuda con los អន ៃថងជាកចបាសនានា េដ ី ឹ ុ ៉ ប់ ុខភាពរបស់ ក ឬរបាក់ costos. Usted tiene derecho a recibir esta información y ayuda en su idioma ់ ់ ើមបនងរកសាទកការធានារា រងស

ក sin costo alguno. Llame al 800-592-6804 (TTY: 800-842-5357). ជ ំ យេចញៃថ កមានសិ េដាយមិ ុ ើ ូ ូ នអសលយេឡយ។ សមទ

ទធ នួ ល។ អន នួ ិ ួលព័ ៌ ិងជំ ន ុងភាសារបស ទទ តមានេនះ ន យេនៅក អន ់

800-592-6804 (TTY: 800-842-5357)។

រស័

ਅੰ

ਜਾਬੀ (Punjabi): paunawa na ito ay maaaring naglalaman ng mahalagang impormasyon ਇਸ ਨੋ ਿਟਸ ਿਵਚ ਖਾਸ ਜਾਣਕਾਰੀ ਹੈ. ਇਸ ਨੋ ਿਟਸ ਿਵਚ LifeWise Health Plan of tungkol sa iyong aplikasyon o pagsakop sa pamamagitan ng LifeWise

Health Plan of Washington. Maaaring may mga mahalagang petsa dito sa Washington ਵਲ ਤੁ ਜ ਅਤੇ ਅਰਜੀ ਬਾਰੇ ਮਹਤਵਪੂ ੋ ਸਕਦੀ ਹਾਡੀ ਕਵਰੇ ੱ ਰਨ ਜਾਣਕਾਰੀ ਹ

ពទ

paunawa. Maaring mangailangan ka na magsagawa ng hakbang sa ilang ਹੈ ੋ ਿਜਸ ਜਵਚ ਖਾਸ ਤਾਰੀਖਾ ਹੋ ਂ ਹਨ. ਜੇ ੁ ੇ ੱ ਖਣੀ ਹੋ ੇ mga itinakdang panahon upang mapanatili ang iyong pagsakop sa . ਇਸ ਨ ਸਕਦੀਆ ਕਰ ਤਸੀ ਜਸਹਤ ਕਵਰਜ ਿਰ ਵ ਜਾ ਓਸ ਦੀ ਲਾਗਤ ਜਿਵੱਚ ਮਦਦ ਦੇ ੱ ੁ ੋ ਤਾਂ ਤੁ ੰ ੂ ਤਮ ਤਾਰੀਖ਼ ਤ ਪਿਹਲਾਂ ਕੁ kalusugan o tulong na walang gastos. May karapatan ka na makakuha ng ਇਛਕ ਹ ਹਾਨ ੱ ਝ ਖਾਸ

ganitong impormasyon at tulong sa iyong wika ng walang gastos. Tumawag ਕਦਮ ਚੁਕਣ ਦੀ ਲੜ ਹੋ ਸਕਦੀ ਹ ੈ,ਤੁ ੰ ੂ ਮੁ ੱ ਚ ਤੇ ੱ ਚ ਜਾਣਕਾਰੀ ਅਤੇ ੱ ੋ ਹਾਨ ਫ਼ਤ ਿਵ ਆਪਣੀ ਭਾਸ਼ਾ ਿਵ ਮਦਦ sa 800-592-6804 (TTY: 800-842-5357). ਪ੍ਰ ੈਾਪਤ ਕਰਨ ਦਾ ਅਿਧਕਾਰ ਹ ,ਕਾਲ 800-592-6804 (TTY: 800-842-5357).

ਪੰ

Tagalog (Tagalog): Ang Paunawa na ito ay naglalaman ng mahalagang impormasyon. Ang

ไทย (Thai): ประกาศน ้ีมีข้อมลูสําคญั ประกาศน ้ีอาจมีข้อมลูที่สําคญัเกี่ยวกบัการการสมคัรหรือขอบเขตประกนั

(Farsi): فارسی فرم بارهدر ھمم اطالعات حاوی است ممکن يهمالعا اين . ميباشد ھمم اطالعات یوحا يهمالعا اين

สขุภาพของคณุผ่าน LifeWise Health Plan of Washington และอาจมีกําหนดการในประกาศ طريق از ماش ای مهبي وششپ يا و تقاضا LifeWise Health Plan of Washington به .باشدี น جهتو يهمالعا اين در ھمم ھای خيتار يا تان بيمه وششپ حقظ برای است کنمم ماش . يدماين کمک คณุอาจจะต้องดําเนินการภายในกําหนดระยะเวลาที่แน่นอนเพื่อจะรักษาการประกนัสขุภาพของคณุ

اجتياح صیاخ کارھای امانج برای صیمشخ ھای خيتار به تان، انیمدر ھای زينهھ پرداخت درหรือการช่วยเหลือที่มีค่าใช้จ่าย คณุมีสิทธิที่จะได้รับข้อมลูและความช่วยเหลือน ้ีในภาษาของคณุโดยไม่ม ีباشيد داشته . رايگان ورط به ودخ انزب به را مکک و اطالعات اين که داريد را اين حق ماش

(ค่าใช้จ่าย โทร 800-592-6804 (TTY: 800-842-5357 مارهش با اطالعات سبک برای . نماييد دريافت 800-592-6804 . اييد نم برقرار استم ) 5357-842-800 مارهباش اس تم TTY کاربران(

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