SARS-Cov-2 Serology (Antibody) Testing, 2.04.518

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BENEFIT COVERAGE GUIDELINE – 2.04.518 SARS-CoV-2 Serology (Antibody) Testing

Effective Date: April 1, 2021 RELATED MEDICAL POLICIES: Last Revised: Mar. 2, 2021 None Replaces: N/A

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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 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 In accordance with Centers for Disease Control (CDC) Interim current/active infection Guidelines for COVID-19 Antibody Testing6 issued May 23, with SARS-CoV-2 2020 and last updated August 1, 2020 and Overview of Testing for SARS-CoV-27 published on June 13, 2020 and last updated October 21, 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

Page | 2 of 13 ∞ Testing Coverage Criteria maximize sensitivity as the sensitivity of nucleic acid detection 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 Serology tests to determine immune status of an individual are determine past infection not covered because such testing is not in accordance with with SARS-CoV-2 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:

Page | 3 of 13 ∞ Documentation Requirements • Office visit notes that contain the relevant history, physical and reason the test is being ordered 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 to identify persons who may be contagious so that measures can be taken to prevent further

Page | 4 of 13 ∞ 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.

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

Page | 5 of 13 ∞ • “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

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.

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:

Page | 6 of 13 ∞ • 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.

Families First Coronavirus Response Act 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.

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 Four 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?

Page | 7 of 13 ∞ 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 Six 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 and updated December 23, 2020) stated:

“…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).

Page | 8 of 13 ∞

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:

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)

Page | 9 of 13 ∞ 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 and updated June 19, 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:

• “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

Page | 10 of 13 ∞ 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 January 21, 2021. Atlanta, GA. Available online: https://www.cdc.gov/coronavirus/2019-ncov/testing/diagnostic-testing.html Accessed March 11, 2021.

2. Centers for Disease Control and Prevention. Test for Past Infection (Antibody Test). Last updated February 2, 2021. Atlanta, GA. Available online at: https://www.cdc.gov/coronavirus/2019-ncov/testing/serology-overview.html Accessed March 11, 2021.

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 March 11, 2021.

4. Centers for Medicare and Medicaid Services. FAQs About Families First Coronavirus Response Act and Coronavirus Aid, Relief, and Economic Security Act Implementation Part 42, Q4. Published April 11, 2020. Baltimore, MD. Available online at: https://www.cms.gov/files/document/FFCRA-Part-42-FAQs.pdf Accessed March 11, 2021.

5. Centers for Medicare and Medicaid Services. FAQs About Families First Coronavirus Response Act and Coronavirus Aid, Relief, and Economic Security Act Implementation Part 42, Q6. Published April 11, 2020. Baltimore, MD. Available online at: https://www.cms.gov/files/document/FFCRA-Part-42-FAQs.pdf Accessed March 11, 2021.

6. Centers for Disease Control and Prevention. Interim Guidelines for COVID-19 Antibody Testing. Last updated August 1, 2020. Atlanta, GA. Available online: https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antibody-tests-guidelines.html. Accessed March 11, 2021.

7. Centers for Disease Control and Prevention. Overview of Testing for SARS-CoV-2. Last updated October 21, 2020. Atlanta, GA. Available online: https://www.cdc.gov/coronavirus/2019-nCoV/hcp/clinical-criteria.html Accessed March 11, 2021.

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 March 11, 2021.

9. Centers for Disease Control and Prevention. COVID-19 Testing Overview. Last updated December 7, 2020. Atlanta, GA. Available online: https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/testing.html. Accessed March 11, 2021.

10. Infectious Diseases Society of America. IDSA. Infectious Diseases Society of America Guidelines on the Diagnosis of COVID-19. Updated December 23, 2020. Arlington, VA. Available online at: https://www.idsociety.org/practice-guideline/covid-19- guideline-diagnostics/ Accessed March 11, 2021.

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 March 11, 2021.

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. Updated June 19, 2020. Silver Spring, MD. Available online: https://www.fda.gov/medical-

Page | 11 of 13 ∞ devices/letters-health-care-providers/important-information-use-serological-antibody-tests-covid-19-letter-healthcare-providers Accessed March 11, 2021.

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 March 11, 2021.

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 March 11, 2021.

15. Centers for Disease Control and Prevention. Interim Guidance for Rapid Antigen Testing for SARS-CoV-2. Last updated December 16, 2020. Atlanta, GA. Available online: https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antigen- tests-guidelines.html Accessed March 11, 2021.

16. Centers for Medicare and Medicaid Services. FAQs About Families First Coronavirus Response Act and Coronavirus Aid, Relief, and Economic Security Act Implementation Part 43. Published June 23, 2020. Baltimore, MD. Available online at: FAQS ABOUT FAMILIES FIRST CORONAVIRUS RESPONSE ACT AND CORONAVIRUS AID, RELIEF, AND ECONOMIC SECURITY ACT IMPLEMENTATION PART 43 (cms.gov) March 11, 2021

17. Centers for Medicare and Medicaid Services. FAQs About Families First Coronavirus Response Act and Coronavirus Aid, Relief, and Economic Security Act Implementation Part 44. Published February 26, 2021.Baltimore, MD. Available online at: https://www.cms.gov/files/document/faqs-part-44.pdf. Accessed March 11, 2021.

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 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.

Page | 12 of 13 ∞ Date Comments 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.

04/01/21 Annual Review, approved March 2, 2021. Benefit coverage guideline reviewed. References updated. Guideline statements unchanged.

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). ©2021 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.

Page | 13 of 13 ∞

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You can file a grievance in person or by mail, fax, or email. If you need help Deutsche (German): filing a grievance, the Civil Rights Coordinator is available to help you. Diese Benachrichtigung enthält wichtige Informationen. Diese

Benachrichtigung enthält unter Umständen wichtige Informationen You can also file a civil rights complaint with the U.S. Department of Health bezüglich Ihres Antrags auf Krankenversicherungsschutz durch Premera and Human Services, Office for Civil Rights, electronically through the Blue Cross. Suchen Sie nach eventuellen wichtigen Terminen in dieser Office for Civil Rights Complaint Portal, available at Benachrichtigung. Sie könnten bis zu bestimmten Stichtagen handeln https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at: müssen, um Ihren Krankenversicherungsschutz oder Hilfe mit den Kosten U.S. Department of Health and Human Services zu behalten. Sie haben das Recht, kostenlose Hilfe und Informationen in 200 Independence Avenue SW, Room 509F, HHH Building Ihrer Sprache zu erhalten. Rufen Sie an unter 800-722-1471 Washington, D.C. 20201, 1-800-368-1019, 800-537-7697 (TDD) (TTY: 800-842-5357). Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html. Hmoob (Hmong):

Tsab ntawv tshaj xo no muaj cov ntshiab lus tseem ceeb. Tej zaum Getting Help in Other Languages 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 This Notice has Important Information. This notice may have important Cross. Tej zaum muaj cov hnub tseem ceeb uas sau rau hauv daim ntawv information about your application or coverage through Premera Blue no. Tej zaum koj kuj yuav tau ua qee yam uas peb kom koj ua tsis pub Cross. There may be key dates in this notice. You may need to take action dhau cov caij nyoog uas teev tseg rau hauv daim ntawv no mas koj thiaj by certain deadlines to keep your health coverage or help with costs. You yuav tau txais kev pab cuam kho mob los yog kev pab them tej nqi kho mob have the right to get this information and help in your language at no cost. ntawd. Koj muaj cai kom lawv muab cov ntshiab lus no uas tau muab sau Call 800-722-1471 (TTY: 800-842-5357). ua koj hom lus pub dawb rau koj. Hu rau 800-722-1471 (TTY: 800-842-5357). አማሪኛ (Amharic): ይህ ማስታወቂያ አስፈላጊ መረጃ ይዟል። ይህ ማስታወቂያ ስለ ማመልከቻዎ ወይም የ Premera Blue Iloko (Ilocano): Cross ሽፋን አስፈላጊ መረጃ ሊኖረው ይችላል። በዚህ ማስታወቂያ ውስጥ ቁልፍ ቀኖች ሊኖሩ ይችላሉ። Daytoy a Pakdaar ket naglaon iti Napateg nga Impormasion. Daytoy a የጤናን ሽፋንዎን ለመጠበቅና በአከፋፈል እርዳታ ለማግኘት በተውሰኑ የጊዜ ገደቦች እርምጃ መውሰድ pakdaar mabalin nga adda ket naglaon iti napateg nga impormasion

ይገባዎት ይሆናል። ይህን መረጃ እንዲያገኙ እና ያለምንም ክፍያ በቋንቋዎ እርዳታ እንዲያገኙ መብት maipanggep iti apliksayonyo wenno coverage babaen iti Premera Blue አለዎት።በስልክ ቁጥር 800-722-1471 (TTY: 800-842-5357) ይደውሉ። Cross. Daytoy ket mabalin dagiti importante a petsa iti daytoy a pakdaar. Mabalin nga adda rumbeng nga aramidenyo nga addang sakbay dagiti Arabic): partikular a naituding nga aldaw tapno mapagtalinaedyo ti coverage ti) العربية salun-atyo wenno tulong kadagiti gastos. Adda karbenganyo a mangala iti يحوي ھذا اإلشعار معلومات ھامة . قد يحوي ھذا اإلشعار معلومات مھمة بخصوص طلبك أو daytoy nga impormasion ken tulong iti bukodyo a pagsasao nga awan ti التغطية التي تريد الحصول عليھا من خالل Premera Blue Cross. قد تكون ھناك تواريخ مھمة .(bayadanyo. Tumawag iti numero nga 800-722-1471 (TTY: 800-842-5357 في ھذا اإلشعار . وقد تحتاج التخاذ إجراء في تواريخ معينة للحفاظ على تغطيتك الصحية أو للمساعدة في دفع التكاليف . يحق لك الحصول على ھذه المعلومات والمساعدة بلغتك دون تكبد أية تكلفة . اتصل :(Italiano (Italian بـ(TTY: 800-842-5357) 800-722-1471 Questo avviso contiene informazioni importanti. Questo avviso può contenere 中文 (Chinese): informazioni importanti sulla tua domanda o copertura attraverso Premera 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 Blue Cross. Potrebbero esserci date chiave in questo avviso. Potrebbe 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 essere necessario un tuo intervento entro una scadenza determinata per 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 consentirti di mantenere la tua copertura o sovvenzione. Hai il diritto di ottenere queste informazioni e assistenza nella tua lingua gratuitamente. 語得到本訊息和幫助。請撥電話。 800-722-1471 (TTY: 800-842-5357) Chiama 800-722-1471 (TTY: 800-842-5357).

037338 (07-2016) 日本語 (Japanese): Română (Romanian): 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 Prezenta notificare conține informații importante. Această notificare 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 poate conține informații importante privind cererea sau acoperirea asigurării 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 dumneavoastre de sănătate prin Premera Blue Cross. Pot exista date cheie în aceast notificare. Este posibil s fie nevoie s ac iona i pân la anumite 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 ă ă ă ț ț ă termene limită pentru a vă menține acoperirea asigurării de sănătate sau 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 asistența privitoare la costuri. Aveți dreptul de a obține gratuit aceste トが無料で提供されます。800-722-1471 (TTY: 800-842-5357)までお電話 informații și ajutor în limba dumneavoastră. Sunați la 800-722-1471 ください。 (TTY: 800-842-5357).

한국어 (Korean): Pусский (Russian): 본 통지서에는 중요한 정보가 들어 있습니다 . 즉 이 통지서는 귀하의 신청에 Настоящее уведомление содержит важную информацию. Это 관하여 그리고 Premera Blue Cross 를 통한 커버리지에 관한 정보를 уведомление может содержать важную информацию о вашем Premera Blue Cross. 포함하고 있을 수 있습니다 . 본 통지서에는 핵심이 되는 날짜들이 있을 수 заявлении или страховом покрытии через В настоящем уведомлении могут быть указаны ключевые даты. Вам, 있습니다. 귀하는 귀하의 건강 커버리지를 계속 유지하거나 비용을 절감하기 возможно, потребуется принять меры к определенным предельным 위해서 일정한 마감일까지 조치를 취해야 할 필요가 있을 수 있습니다 . срокам для сохранения страхового покрытия или помощи с расходами. 귀하는 이러한 정보와 도움을 귀하의 언어로 비용 부담없이 얻을 수 있는 Вы имеете право на бесплатное получение этой информации и 권리가 있습니다 . 800-722-1471 (TTY: 800-842-5357) 로 전화하십시오 . помощь на вашем языке. Звоните по телефону 800-722-1471 (TTY: 800-842-5357). ລາວ (Lao): Fa’asamoa (Samoan): ້ ້ ້ ້ ແຈ້ງການນີ ມີ ຂໍ ມູ ນສໍ າຄັ ນ. ແຈ້ງການນີ ອາດຈະມີ ຂໍ ມູ ນສໍ າຄັ ນກ່ ຽວກັບຄໍ າຮ້ອງສະ Atonu ua iai i lenei fa’asilasilaga ni fa’amatalaga e sili ona taua e tatau ໝັ ກ ຫືຼ ຄວາມຄຸ້ ມຄອງປະກັນໄພຂອງທ່ານຜ່ານ Premera Blue Cross. ອາດຈະມີ ona e malamalama i ai. O lenei fa’asilasilaga o se fesoasoani e fa’amatala ວັນທີ ສໍ າຄັ ນໃນແຈ້ງການນີ້ . ທ່ານອາດຈະຈໍ າເປັ ນຕ້ອງດໍ າເນີ ນການຕາມກໍ ານົ ດ atili i ai i le tulaga o le polokalame, Premera Blue Cross, ua e tau fia maua ເວລາສະເພາະເພື່ ອຮັກສາຄວາມຄຸ້ ມຄອງປະກັນສຸ ຂະພາບ ຫືຼ ຄວາມຊ່ວຍເຫືຼ ອເລື່ ອງ 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 ້ ້ ຄ່ າໃຊ້ຈ່າຍຂອງທ່ານໄວ້ . ທ່ານມີ ສິ ດໄດ້ ຮັບຂໍ ມູ ນນີ ແລະ ຄວາມຊ່ວຍເຫືຼ ອເປັ ນພາສາ aso ua ta’ua i lenei fa’asilasilaga ina ia e iai pea ma maua fesoasoani mai ai ຂອງທ່ານໂດຍບໍ່ ເສຍຄ່ າ. ໃຫ້ໂທຫາ 800-722-1471 (TTY: 800-842-5357). 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 徶羶ែខមរ (Khmer): ai aunoa ma se togiga tupe. Vili atu i le telefoni 800-722-1471 (TTY: 800-842-5357). េសចកតជី ូនដណំ ឹងេនះ掶នព័ត៌掶ន架៉ ងស޶នំ។ ់ េសចកតីជូនដំណឹងេនះរបែហល ᾶ掶នព័ត៌掶ន架៉ ងសំ޶ន់អពំ ីទរមង់ ែបបបទ ឬζរ殶៉ បរង់ របសអ់ នក㾶មរយៈ Español (Spanish): Premera Blue Cross ។ របែហលᾶ掶ន ζលបរ េចិ ឆទសំ޶ន់េ俅កន ុងេសចកតជី ូន Este Aviso contiene información importante. Es posible que este aviso contenga información importante acerca de su solicitud o cobertura a ដណំ ងេនះ។ឹ អនករបែហលᾶរតវζរបេញូ ច ញសមត徶ពថ ដលក់ ណតំៃថ ់ ងᾶកច厶់ ស់ través de Premera Blue Cross. Es posible que haya fechas clave en este 侶侶 េដើមបីនងរកឹ 羶ទកζរ䮶侶ុ 殶៉ បរង់ សខ徶ពរបសុ ់អនក ឬរ厶កជ់ ំនួយេចញៃថល។ aviso. Es posible que deba tomar alguna medida antes de determinadas អនក掶នសទិ ធទទិ ួលព័ត掶នេ៌ នះ និងជំនួយេ俅កន ុង徶羶របស់អនកេ⮶យមនអសិ fechas para mantener su cobertura médica o ayuda con los costos. Usted លយេឡុ ើយ។ សូ មទូរស័ពទ 800-722-1471 (TTY: 800-842-5357)។ tiene derecho a recibir esta información y ayuda en su idioma sin costo alguno. Llame al 800-722-1471 (TTY: 800-842-5357).

ਪ ੰ ਜਾਬੀ (Punjabi): Tagalog (Tagalog): ਇਸ ਨ ੋ ਿਟਸ ਿਵਚ ਖਾਸ ਜਾਣਕਾਰੀ ਹੈ. ਇਸ ਨ ੋ ਿਟਸ ਿਵਚ Premera Blue Cross ਵਲ ਤੁਹਾਡੀ Ang Paunawa na ito ay naglalaman ng mahalagang impormasyon. Ang paunawa na ito ay maaaring naglalaman ng mahalagang impormasyon ਕਵਰਜੇ ਅਤ ੇ ਅਰਜੀ ਬਾਰ ੇ ਮਹ ੱ ਤਵਪਰਨੂ ਜਾਣਕਾਰੀ ਹ ੋ ਸਕਦੀ ਹ ੈ . ਇਸ ਨ ੋ ਿਜਸ ਜਵਚ ਖਾਸ ਤਾਰੀਖਾ . tungkol sa iyong aplikasyon o pagsakop sa pamamagitan ng Premera Blue ਹੋ ਸਕਦੀਆਂ ਹਨ ਜੇਕਰ ਤਸੀੁ ਜਸਹਤ ਕਵਰਜੇ ਿਰੱ ਖਣੀ ਹਵੋ ੇ ਜਾ ਓਸ ਦੀ ਲਾਗਤ ਜਿਵੱ ਚ ਮਦਦ ਦੇ Cross. Maaaring may mga mahalagang petsa dito sa paunawa. Maaring ਇਛ ੱ ੁਕ ਹ ੋ ਤ拓 ਤਹਾਨ ੁ ੰ ੂ ਅ ੰ ਤਮ ਤਾਰੀਖ਼ ਤ ਪਿਹਲ拓 ਕੁੱ ਝ ਖਾਸ ਕਦਮ ਚੱ ਕਣ ੁ ਦੀ ਲੋੜ ਹ ੋ ਸਕਦੀ ਹ ੈ ,ਤੁਹਾਨੰ ੂ mangailangan ka na magsagawa ng hakbang sa ilang mga itinakdang ਮਫ਼ਤੁ ਿਵੱ ਚ ਤ ੇ ਆਪਣੀ ਭਾਸ਼ਾ ਿਵ ੱ ਚ ਜਾਣਕਾਰੀ ਅਤ ੇ ਮਦਦ ਪਾਪਤ㘰 ਕਰਨ ਦਾ ਅਿਧਕਾਰ ਹੈ ,ਕਾਲ panahon upang mapanatili ang iyong pagsakop sa kalusugan o tulong na 800-722-1471 (TTY: 800-842-5357). walang gastos. May karapatan ka na makakuha ng ganitong impormasyon at tulong sa iyong wika ng walang gastos. Tumawag sa 800-722-1471 .(Farsi): (TTY: 800-842-5357) فارسی اين اعالميه حاوی اطالعات مھم ميباشد .اين اعالميه ممکن است حاوی اطالعات مھم درباره فرم :(ไทย (Thai تقاضا و يا پ وشش بيمه ای شما از طريق Premera Blue Cross باشد . به تاريخ ھای مھم در ั ประกาศนมข้ี ี ้อมลส ู ําคญ ั ประกาศนอาจม ้ี ีข ้อมลท ู ่ีส ําคญเก ั ่ียวกบการการสม ัครหร ั ือขอบเขตประกน اين اعالميه توجه نماييد .شما ممکن است برای حقظ پوشش بيمه تان يا کمک در پرداخت ھزينه . สขภาพของคุณผ ุาน ่ Premera Blue Cross และอาจมีก ําหนดการในประกาศนี ้ คณอาจจะต ุ ้อง ھای درمانی تان، به تاريخ ھای مشخصی برای انجام کارھای خاصی احتياج داشته باشيد شما حق اين را داريد که اين اطالعات و ک مک را به زبان خود به طور رايگان دريافت نماييد . برای کسب ี่ ดําเน ินการภายในกาหนดระยะเวลาท ํ ่ีแนนอนเพ ่ ่ือจะร ักษาการประกนส ัขภาพของค ุณหร ุ ือการช ่วยเหล ือท اطالعات با شماره 1471-722-800 (کاربران TTY تماس باشماره 5357-842-800) تماس มคี่้่าใชจาย คณม ุีิิ่ี้ัู้สทธทจะไดรบขอมลและความชวยเหล ่ ื้ีอนในภาษาของคณโดยไม ุ่มค ี่้่าใชจาย โทร برقرار نماييد . 800-722-1471 (TTY: 800-842-5357) Polskie (Polish): To og oszenie mo e zawiera wa ne informacje. To og oszenie mo e ł ż ć ż ł ż Український (Ukrainian): zawiera wa ne informacje odno nie Pa stwa wniosku lub zakresu ć ż ś ń Це повідомлення містить важливу інформацію. Це повідомлення świadczeń poprzez Premera Blue Cross. Prosimy zwrócic uwagę na може містити важливу інформацію про Ваше звернення щодо kluczowe daty, które mogą być zawarte w tym ogłoszeniu aby nie страхувального покриття через Premera Blue Cross. Зверніть увагу на przekroczyć terminów w przypadku utrzymania polisy ubezpieczeniowej lub ключові дати, які можуть бути вказані у цьому повідомленні. Існує pomocy zwi zanej z kosztami. Macie Pa stwo prawo do bezp atnej ą ń ł імовірність того, що Вам треба буде здійснити певні кроки у конкретні informacji we własnym języku. Zadzwońcie pod 800-722-1471 кінцеві строки для того, щоб зберегти Ваше медичне страхування або (TTY: 800-842-5357). отримати фінансову допомогу. У Вас є право на отримання цієї

інформації та допомоги безкоштовно на Вашій рідній мові. Дзвоніть за Português (Portuguese): номером телефону 800-722-1471 (TTY: 800-842-5357). Este aviso contém informações importantes. Este aviso poderá conter informações importantes a respeito de sua aplicação ou cobertura por meio Tiếng Việt (Vietnamese): do Premera Blue Cross. Poderão existir datas importantes neste aviso. Thông báo này cung cấp thông tin quan trọng. Thông báo này có thông Talvez seja necessário que você tome providências dentro de tin quan trọng về đơn xin tham gia hoặc hợp đồng bảo hiểm của quý vị qua determinados prazos para manter sua cobertura de saúde ou ajuda de chương trình Premera Blue Cross. Xin xem ngày quan trọng trong thông custos. Você tem o direito de obter esta informação e ajuda em seu idioma báo này. Quý vị có thể phải thực hiện theo thông báo đúng trong thời hạn e sem custos. Ligue para 800-722-1471 (TTY: 800-842-5357). để duy trì bảo hiểm sức khỏe hoặc được trợ giúp thêm về chi phí. Quý vị có quyền được biết thông tin này và được trợ giúp bằng ngôn ngữ của mình miễn phí. Xin gọi số 800-722-1471 (TTY: 800-842-5357).