COVID-19 Testing

Policy No: 137
Date of Origin: 05/18/2020
Section: Administrative
Last Reviewed: 12/18/2020
Last Revised: 12/18/2020
Approved: 01/14/2021
Effective: 01/01/2021

This policy applies to all contracted physicians, other health care professionals, hospitals and other facilities.

Rationale

The American Medical Association (AMA) cautions physicians and the general public about use of antibody tests to determine “individual immunity and warns that public health decisions, such as discontinuation of physical distancing, should not be made on the basis of results. Physicians and the general public need to be aware that serology tests have several inherent limitations that make correct interpretation of the results critical. Serological tests for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibodies present even greater challenges, as much is still unknown about immune status for the novel virus. Some limitations to be aware of include… false positive results, cross-reactivity, and incorrect immune status" (see Reference section, #6).

The Centers for Disease Control and Prevention (CDC) recommends using authorized nucleic acid or antigen detection assays that have received a Food and Drug Administration (FDA) Emergency Use Authorization (EUA) to test persons with symptoms when there is a concern of potential Coronavirus (COVID-19). Tests should be used in accordance with the authorized labeling; providers should be familiar with the tests’ performance characteristics and limitations.(see Reference section, #2)

CDC does not currently recommend using antibody testing as the sole basis for diagnosis of acute infection, and antibody tests are not authorized by FDA for such diagnostic purposes. In certain situations, serologic assays may be used to support clinical assessment of persons who present late in their illnesses when used in conjunction with viral detection tests. In addition, if a person is suspected to have post-infectious syndrome (e.g., Multisystem Inflammatory Syndrome in Children) caused by SARS-CoV-2 infection, serologic assays may be used.(see Reference section, #2)

Equal Employment Opportunity Commission (EEOC) published June 17, 2020 in follow up to CDC’s publication that “..requiring antibody testing before allowing employees to re-enter the workplace is not allowed under the Americans with Disabilities Act (ADA)” (see Reference section, #14)

Definitions

In Vitro Diagnostics: Tests done on biological samples including but not limited to blood, tissue, saliva or tissue that have been taken from the human body. In Vitro Diagnostic tests include Molecular, Antigen and Antibody testing for COVID-19.

Diagnostic Test Tests done to diagnose a current SARS-CoV-2 infection or to support clinical assessment of persons suspected to have post-infectious syndrome. This can include molecular/nucleic acid and antigen testing. Antibody testing is included as In Vitro Diagnostic testing.

Viral Tests: Include tests that are both molecular (PCR-based) and antigen tests. These tests are designed to identify viral molecules and are used to diagnose active SARS-CoV-2 infection. They require testing of samples taken nasal or throat swabs or from saliva.

Molecular/Nucleic acid Tests: Molecular tests that identify the RNA of the virus. Reverse Transcription Polymerase chain reaction (RT-PCR) is a type of molecular testing. COVID-19 molecular testing can be collected from nasal swabs to identify if an individual has a current infection.

Antigen Tests: Tests that detect proteins on or within the virus that identify if an individual has a current infection.

Antibody blood tests: “Serological” or “antibody” tests detect the presence of antibodies within a patient’s blood sample to determine if an individual had an immune response to a past infection. They do not show whether a person is currently infected

Attending Provider: Provider responsible for overseeing a patient’s medical record and treatment at the time of the patient’s visit

SARS-CoV-2: The virus that causes COVID-19 (see Reference section, #1)

COVID-19: An infectious disease caused by the newly emerged coronavirus SARS-CoV-2

Neutralizing antibody tests: tests designed to detect the presence of antibodies that may be able to neutralize the SARS-CoV-2 virus.

Policy Statement

We cover COVID-19 viral (molecular and antigen) and antibody testing, subject to daily limitations, done for the detection of SARS-CoV-2 or the diagnosis of the virus that causes COVID-19 in accordance with the Families First Coronavirus Response Act (see Regulatory Statutes section, B.) through the end of the Federal Public Health Emergency and when the following criteria is met:

  • Ordered by attending provider or effective 4/8/2020 a pharmacist licensed and enrolled in the state that the services are rendered in and practicing within the scope of their license and part of appropriate medical care as determined by the attending health care provider
  • Test must be performed by a CLIA Certified Laboratory or Manufacturer of test must be approved or authorized by the FDA or have been approved for Emergency Use Authorization (EUA) for the COVID-19 Pandemic

The name of the test manufacturer must be included on the claim submission.

Per the CDC Viral tests are the only tests recommended to diagnose a current COVID-19 infection. Antibody testing is not currently recommended as the sole basis to diagnose an acute infection and is not “authorized by the FDA for such diagnostic purposes”. (see Reference section, #2)

COVID-19 testing is NOT reimbursable for purposes including, but not limited to, the following:

  • epidemiologic purposes
  • surveillance
  • community tracking
  • employment purposes, including staffing decisions
  • determine need for personal protective equipment
  • screening (e.g., travel, sports, school, camp, recreational, social requirement)

Neutralizing antibody testing is not intended to be used as a method for determining whether a person has been infected with SARS-CoV-2. COVID-19 neutralizing antibody testing (including surrogate neutralizing antibody testing) is considered not medically necessary per LAB74 Medical Policy.

Providers must include the appropriate diagnosis and/or modifier(s) to indicate if testing is done for the above reasons.

Billing

We identify COVID-19 Diagnostic Testing when testing procedure codes are billed with the following:
a) CS modifier billed on appropriate line item OR
b) Diagnosis Z20.822 billed on appropriate line item effective January 1, 2021

For quicker claims payment provide the following when submitting the claim:

  • the FDA EUA approved test manufacturer name on the claim
  • the Referring/Ordering provider’s Identification number

Testing Procedure Codes
Molecular Tests: U0001, U0002, U0003, U0004, U0005, 87635, 87636, 87637, 0202U, 0223U, 0225U, 0240U, 0241U
Antigen Tests: 87426, 87428, 87449, 87811
Antibody Tests: 86769, 86328, 0224U, 86413
Specimen Collection: G2023, G2024, C9803

Procedure codes

Molecular

0202U

Infectious disease (bacterial or viral respiratory tract infection), pathogen-specific nucleic acid (DNA or RNA), 22 targets including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), qualitative RT-PCR, nasopharyngeal swab, each pathogen reported as detected or not detected; BioFire® Respiratory Panel 2.1 (RP2.1), BioFire® Diagnostics, BioFire® Diagnostics, LLC; Effective 5/20/2020; Published 5/20/2020

0223U

Infectious disease (bacterial or viral respiratory tract infection), pathogen-specific nucleic acid (DNA or RNA), 22 targets including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), qualitative RT-PCR, nasopharyngeal swab, each pathogen reported as detected or not detected; QIAstat-Dx Respiratory, SARS-CoV-2 Panel, QIAGEN Sciences, QIAGEN GMbHb; Effective 6/25/2020; Published 6/25/2020

0225U

Infectious disease (bacterial or viral respiratory tract infection) pathogen-specific DNA and RNA, 21 targets, including severe acute respiratory syndrome coronavirus 2 (SARSCoV-2), amplified probe technique, including multiplex reverse transcription for RNA targets, each analyte reported as detected or not detected; ePlex® Respiratory Pathogen Panel 2, GenMark Diagnostics; Effective 8/10/2020; Published 8/10/2020

0240U

Infectious disease (viral respiratory tract infection), pathogen-specific RNA, 3 targets (severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A, influenza B), upper respiratory specimen, each pathogen reported as detected or not detected; Xpert Xpress SARS-CoV-2 & Flu Targets Only), Cepheid; Effective 10/6/2020; Published 10/6/2020

0241U

Infectious disease (viral respiratory tract infection), pathogen-specific RNA, 4 targets (severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A, influenza B, respiratory syncytial virus (RSV)), upper respiratory specimen, each pathogen reported as detected or not detected; Xpert ® Xpress SARS-CoV-2/Flu/RSV (all targets), Cepheid; Effective 10/6/2020; Published 10/6/2020

87635

Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease COVID-19), amplified probe technique; Effective 3/13/2020

87636

Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease COVID-19) and influenza virus types A and B, multiplex amplified probe technique; Effective 10/6/2020; Published 10/6/2020

87637

Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease (COVID-19), influenza virus types A and B, and respiratory syncytial virus, multiplex amplified probe technique; Effective 10/6/2020; Published 10/6/2020

U0001

CDC 2019 Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel; Effective 2/4/2020; Published 2/6/2020

U0002

2019-nCoV Coronavirus, SARS-CoV-2/2019-nCoV (COVID-19), any technique, multiple types or subtypes (includes all targets), non-CDC; Effective 2/4/2020; Published 3/5/2020

U0003

Infectious agent detection by nucleic acid (DNA or RNA); Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) (Coronavirus disease COVID-19), amplified probe technique, making use of high throughput technologies as described by CMS-2020-01-R; Effective 4/14/2020; Published 4/14/2020

U0004

2019-nCoV Coronavirus, SARS-CoV-2/2019-nCoV (COVID-19), any technique, multiple types or subtypes (includes all targets), non-CDC, making use of high throughput technologies as described by CMS-2020-01-R; Effective 4/14/2020; Published 4/14/2020

U0005

Infectious agent detection by nucleic acid (DNA or RNA); Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) (Coronavirus disease (COVID-19), amplified probe technique, CDC or non-CDC, making use of high throughput technologies, completed within 2 calendar days from date of specimen collection (list separately in addition to either HCPCS code U0003 or U0004) as described by CMS-2020-01-R2; Effective 1/1/2021; Published 12/18/2020

Procedure codes

Antigen

87426

Infectious agent antigen detection by immunoassay technique, (e.g., enzyme immunoassay - EIA, enzyme-linked immunosorbent assay - ELISA, fluorescence immunoassay (FIA), immunochemiluminometric assay - IMCA) qualitative or semiquantitative, multiple-step method; severe acute respiratory syndrome coronavirus (e.g., SARS-CoV, SARS-CoV-2 COVID-19); Effective 6/25/2020; Published 6/25/2020

87428

Infectious agent antigen detection by immunoassay technique, (eg, enzyme immunoassay (EIA), enzyme-linked immunosorbent assay (ELISA), fluorescence immunoassay (FIA), immunochemiluminometric assay (IMCA) qualitative or semiquantitative; severe acute respiratory syndrome coronavirus (eg, SARS-CoV, SARS-CoV-2 COVID-19) and influenza virus types A and B; Effective 11/10/2020; Published 11/10/2020

87449

Infectious agent antigen detection by immunoassay technique, (eg, enzyme immunoassay - EIA, enzyme-linked immunosorbent assay - ELISA, fluorescence immunoassay (FIA), immunochemiluminometric assay - IMCA), qualitative or semiquantitative; multiple-step method, not otherwise specified, each organism; Effective 5/8/2020 when first Antigen Test was approved for FDA EUA

87811

Infectious agent antigen detection by immunoassay with direct optical (ie, visual) observation; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease COVID-19) ; Effective 10/6/2020; Published 10/6/2020

Procedure codes

Antibody

0224U

Antibody, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease COVID-19), includes titer(s), when performed; Mt Sinai, Mount Sinai Laboratory; Effective 6/25/2020; Published 6/25/2020

Current Procedural Terminology (CPT®) Proprietary Laboratory Analyses (PLA) code 0224U describes qualitative and quantitative detection of antibodies in serum and plasma. The test may aid in determining whether an individual suspected of significant exposure or prior infection with SARS-CoV-2 virus has a high titer of IgG antibodies against this virus when performed. (Do not report 0224U in conjunction with 86769)

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); Effective 4/10/2020; Published 4/10/2020

Current Procedural Terminology (CPT®) code 86328 was established to report antibody testing performed using single-step method immunoassay. The test is performed using a strip that contains all of the critical components for testing from a blood or serum sample; and should be reported once for each reagent strip assay.

86413

Severe acute repiratory syndrome coronavirus 2 (SARSCoV-2) (Coronavirus disease COVID-19) antibody, quantitative; Effective 9/8/2020; Published 9/8/2020

86769

Antibody; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease COVID-19) Multi-step method; Effective 4/10/2020; Published 4/10/2020

Current Procedural Terminology (CPT®) code 86769 describes antibody testing performed using a multiple-step method on a blood or serum sample and should be reported once for each separate assay that is performed. If two different assays are performed on different immunoglobulin classes (e.g., IgG and IgM), code would be reported twice with modifier 59 appended to the second assay.

Procedure codes

Neutralizing Antibody

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

0226U

Surrogate viral neutralization test (sVNT), severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease COVID-19), ELISA, plasma, serum; Tru-Immune™ Ethos Laboratories, GenScript; Effective 8/10/2020; Published 8/10/2020

Specimen collection

Specimen collection

C9803

Hospital outpatient clinic visit specimen collection for severe acute respiratory syndrome coronavirus 2 (sars-cov-2) (coronavirus disease covid-19), any specimen source; Effective 3/1/2020; Published 5/7/2020

G2023

Specimen collection for severe acute respiratory syndrome coronavirus 2 (sars-cov-2) (coronavirus disease covid-19), any specimen source; Effective 3/1/2020; Published 3/31/2020

G2024

Specimen collection for severe acute respiratory syndrome coronavirus 2 (sars-cov-2) (coronavirus disease covid-19) from an individual in a snf or by a laboratory on behalf of a hha, any specimen source; Effective 3/1/2020; Published 3/31/2020

Diagnosis codes

Diagnosis codes

U07.1

COVID-19; Effective 4/1/2020; Published 3/18/2020 to indicate confirmed COVID-19 infection

Z20.822

Contact with and (suspected) exposure to COVID-19; Effective 1/1/2021; Published 11/30/2020 to replace use Z20.828 to indicate appropriate COVID-19 testing

Modifier

Modifier

CS

Cost-sharing for specified covid-19 testing-related services that result in an order for or administration of a covid-19 test; Effective 3/18/2020; Published 4/7/2020

CR

Catastrophe/disaster related; Effective 3/1/2020; Published 3/20/2020

Cross References

None

Disclaimer

Your use of this Reimbursement Policy constitutes your agreement to be bound by and comply with the terms and conditions of the Reimbursement Policy Disclaimer.