Antibody Testing For Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2) Form

Health New England Commercial Clinical Policy

Effective Date

Last Reviewed

Original Document

Clinical Review Criteria Related to Antibody Testing for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) [Coronavirus Disease (COVID-19)]
Effective 2/1/2023 (Date of Last Review: 11/8/2022)

Clinical Review Criteria Related to Antibody Testing for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) [Coronavirus Disease (COVID-19)]

Definitions:

• Antibody (Serology) Testing: A blood test that looks for antibodies to determine if person has been infected with COVID-19 in the past. Test looks for antibodies within blood which are proteins in blood. In Vitro testing is a test performed in vitro (in the glass) meaning that the test is done outside of a living organism. Test usually involves organs, cells or isolated tissues. • Neutralizing Antibodies: Neutralizing antibodies inhibit viral replication in vitro, and their presence correlates with immunity to future infection, at least temporarily (CDC). Neutralizing antibody testing is experimental. • Multi-System Inflammatory Syndrome in Children (MIS-C): A condition where different body parts can become inflamed, including: heart, lungs, kidneys, brain, skin, eyes or gastrointestinal organs. Symptoms may include abdominal pain, vomiting, diarrhea, neck pain, rash, bloodshot eyes or feeling extra tired. Cause is unknown but children may have had the virus that causes COVID- 19, or been around someone with COVID-19.
• Convalescent Plasma Donation: Individuals who have fully recovered from COVID-19 for at least two weeks are encouraged to consider donating plasma, which may help save the lives of other patients. COVID-19 convalescent plasma must only be collected from recovered individuals if they are eligible to donate blood (FDA).

Policy:

Summary of COVID-19 Information:

• Coronavirus (COVID-19) is an illness caused by a coronavirus COVID-19 called SARS-CoV-2 that can spread from person to person contact. The virus that causes COVID-19 is a new coronavirus that has spread throughout the world.
• COVID-19 symptoms can range from mild (or no symptoms) to severe illness. • COVID-19 symptoms include: Fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea, vomiting or diarrhea. • COVID-19 symptoms requiring medical attention include: Trouble breathing, persistent pain or pressure in chest, new confusion, inability to wake or stay awake and/or bluish lips or face.

I. Criteria for Approval: For All Lines of Business

A. An antibody (serology) test for SARS-CoV-2 antibodies in individual being tested for Multi- System Inflammatory Syndrome in Children (MIS-C) is medically necessary when all the criteria below are met:

Test is recommended by a health care provider.

Test has been FDA approved or cleared for Emergency Use Authorization (EUA).
Test is performed by a CLIA-accredited high- or medium-complexity laboratory (per test Instructions for Use).
When results of a molecular or antigen test are non diagnostic for COVID-19 and the results of the test will be used to aid in the diagnosis

II. Required Documentation:
A. Medical documentation that member meets criteria above

III. What is Not Covered:
A. Molecular, antigen or antibody (serology) testing for any indication other than the ones listed above in I. Criteria for Approval
B. Testing to determine the need for quarantine, Personal Protective Equipment (PPE), social distancing and congregate housing
C. Any testing for neutralizing antibodies
D. Over the counter tests for the diagnosis of a COVID-19
CPT Codes: CPT Codes: Code Description:
0226U Surrogate viral neutralization test (sVNT), severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), ELISA, plasma, serum
86408 Neutralizing antibody, severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2) (Coronavirus disease [COVID-19]); screen
86409 Neutralizing antibody, severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2) (Coronavirus disease [COVID-19]); titer 86413 Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]) antibody, quantitative 86328 Immunoassay for infectious agent antibody(ies), qualitative or semiquantitative, single step method (e.g., reagent strip); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]) 86769 Antibody; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19])

02244U

Antibody, severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) (Coronavirus disease [COVID-19]), includes titer(s), when performed

Medical Criteria Disclaimer:

Property of Health New England. All rights reserved. The treating physician or primary care provider must submit to Health New England the clinical evidence that the patient meets the criteria for the treatment, testing or surgical procedure. Without this documentation and information, Health New England will not be able to properly review the request for prior authorization. The clinical review criteria reflect how Health New England determines whether certain services or supplies are medically necessary. Health New England established the clinical review criteria based upon a review of currently available clinical information (including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the technology, evidence-based guidelines of public health and health research agencies, evidence-based guidelines and positions of leading national health professional organizations, views of physicians practicing in relevant clinical areas, and other relevant factors). Health New England expressly reserves the right to revise these conclusions as clinical information changes, and welcomes further relevant information. Each benefit program defines which services are covered. The conclusion that a particular service or supply is medically necessary does not constitute a representation or warranty that this service, testing or supply is covered and/or paid for by Health New England, as some programs exclude coverage for services, testing or supplies that Health New England considers medically necessary. If there is a discrepancy between this guideline and a member's benefits program, the benefits program will govern. In addition, coverage may be mandated by applicable legal requirements of a state, the Federal Government or the Centers for Medicare & Medicaid Services (CMS) for Medicare and Medicaid members. All coding and web site links are accurate at time of publication. Health New England has adopted the herein policy in providing management, administrative and other services to its Health Plan.

REFERENCES:

NCQA Standard, UM 2, Clinical Criteria for Utilization Management Decisions, Element A

About COVID-19 testing, what you need to know about testing for COVID-19 in Massachusetts.
Retrieved August 12, 2022, from

https://www.mass.gov/info-details/about-covid-19-testing

Centers for Disease Control and Prevention, COVID-19 Science Update released: December 17, 2021, Edition. Retrieved on August 12, 2022, from

https://www.cdc.gov/library/covid19/12172021_covidupdate.html

https://www.cdc.gov/coronavirus/2019-ncov/more/science-and-research.html

Coronavirus (COVID-19) Understanding Risk. Retrieved August 12, 2022, from

https://www.coronavirus.gov/

Interim Guidelines for COVID-19 Antibody Testing (Updated January 24, 2022 ). Retrieved August 12, 2022, from

Interim Guidelines for COVID-19 Antibody Testing | CDC

American Medical Association. (2020, May ). Serological testing for SARS-CoV-2 antibodies.
Accessed August 12, 2022, from

https://www.ama-assn.org

Centers for Disease Control and Prevention (Updated April 26, 2022) What You Need to Know About Variants. Retrieved August 12, 2022, from:

  https://www.cdc.gov/coronavirus/2019-ncov/variants/delta-variant.html

Infectious Diseases Society of America (2020, August 18). Infectious Diseases Society of America guidelines on the diagnosis of COVID-19: Serologic testing. Accessed August 12, 2022, from https://www.idsociety.org/practice-guideline/covid-19-guideline-serology/

Kadkhodia, K. (2020, June). COVID-19 serologic testing: FAQs and caveats. Cleveland Clinic Journal of Medicine, 87(6), 329-333. Accessed on August 12, 2022, from

https://www.ccjm.org/content/87/6/329

Massachusetts Department of Public Health (nd). About COVID-19 Testing. What you need to know about testing for COVID-19 in Massachusetts. Accessed August 12, 2022, from

https://www.mass.gov/info-details/about-covid-19-testing.

U.S. Food and Drug Administration (5/19/2022), Know your treatment options for Covid-19.
Retrieved August 12, 2022, from:

 https://www.fda.gov/consumers/consumer-updates/know-your-treatment-options-covid-19

Massetti, PhD, G, Jackson , MD, B, Brooks, MD, J, Perrine, PhD, C, Reott, MPH, E, et.al. Centers for Disease Control and Prevention, “Summary of Guidance for Minimizing the Impact of COVID-19 on Individual Persons, Communities, and Health Care Systems — United States, August 2022.
Retrieved August 12, 2022, from:

  Summary of Guidance for Minimizing the Impact of COVID-19 on Individual Persons,

Communities, and Health Care Systems — United States, August 2022 (cdc.gov)

Center for Disease Control, Covid-19 by County (updated August 11, 2022). Retrieved August 12, 2022, from: COVID-19 by County | CDC

Centers for Disease Control and Prevention, Understanding Risk (Updated August 11, 2022).
Retrieved August 12, 2022, from:

 https://www.cdc.gov/coronavirus/2019-ncov/your-health/understanding-risk.html

Centers for Disease Control and Prevention, What’s New and Updated, Covid-19. Retrieved August 12, 2022, from:

https://www.cdc.gov/coronavirus/2019-ncov/whats-new-all.html

Date Policy Changes 9/22 • No significant changes

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Antibody Testing For Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2) Form

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