TESTING FOR SEVERE ACUTE RESPIRATORY SYNDROME CORONAVIRUS 2 (SARS-COV-2)

V.64





V.64 TESTING FOR SEVERE ACUTE RESPIRATORY SYNDROME CORONAVIRUS 2 (SARS-COV-2)


Policy

I.  Diagnostic testing for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) to determine current COVID-19 infection using viral direct detection methods such as nucleic acid amplification or antigen detection (U0001, U0002, U0003, U0004, 87635) may be considered medically appropriate when performed for the diagnosis and/or treatment of acute infection in symptomatic patients or in patients with a reasonable suspicion of exposure.

A.  Diagnostic testing pre-operatively is medically appropriate.

II.  Routine diagnostic testing for SARS-CoV-2 with viral direct detection methods in asymptomatic individuals solely for epidemiologic, public health, and employment purposes (e.g. routine screening, return to work screening) is considered not medically appropriate. 

Section 6001 of the FFCRA requires coverage of items and services only for diagnostic purposes as outlined in this guidance.  Clinical decisions about testing are made by the individual's attending health care provider and may include testing of individuals with signs or symptoms compatible with COVID-19, as well as asymptomatic individuals with known or suspected recent exposure to SARS-CoV-2, that is determined to be medically appropriate by the individual's health care provider, consulting CDC guidelines as appropriate.  Howevr, testing conducted to screen for general workplace health and safety (such as employee "return to work" programs), for public health surveillance for SARS-CoV-2, or for any other purpose not primarily intended for individualized diagnosis or treatment of COVID-19 or another health condition is beyond the scope of section 6001 of the FFCRA.

 

III.  Antibody testing (aka serology testing) for SARS-Cov-2 to determine antibody status (86328, 86769) maybe considered medically appropriate when:

A.  Antibody testing is necessary to guide the clinical management of the individual patient; AND

B.  At least one diagnostic test for SARS-Cov-2 using a viral direct detection method has been performed on the patient; AND

C.  The particular antibody test is FDA approved or FDA authorized (including Emergency Use Authorization (EUA)); AND

D.  The test has been ordered by a licensed health care provider

 

IV.  Antibody testing as the sole basis for diagnosing active COVID-19 infection is not considered medically appropriate. 

 

V.   Antibody testing performed solely to determine an individual's immunity to COVID-19 infection is considered investigational.  CPT codes 86408, 86409 for testing  to identify a person's eligibility for plasma donation are not necessary for diagnosis and/or treatment and will not be covered and considered investigational.

 

VI.  All other antibody testing for SARS-CoV-2, including testing for epidemiological public health, and employment purposes (e.g. routine screening, return to work screening) is considered not medically appropriate (See #II above). 

 



Dates

  • Original Effective
    11-01-2020
  • Last Review
    08-07-2024
  • Next Review
    08-11-2025

Description

Testing of respiratory tract specimens with methods using direct detection of the SARS-CoV-2 virus nucleic acids is the recommended method of diagnosing infection.  This direct detection viral nucleic acid testing is considered critical for accurate diagnosis and for patient care, hospital infection control, and appropriate public health measures.

Antibody tests (also known as serology tests) are blood tests that are designed to detect antibodies that a person has generated in response to an infection in the past.  Unlike viral direct detection diagnostic tests, antibody tests do not detect the presence of viral molecules.  There is a variable time lag between infection with SARS=CoV-2 and production of measurable quantities of antibodies to the virus.

In response to the COVID-19 pandemic, the U.S Food and Drug Administration (FDA) has used its Emergency Use Authorization (EUA) authority to allow the use of SARS-Cov-2 antibody tests that have not received traditional FDA approval.  EUA-authorized antibody tests must have been evaluated in an independent validation study performed at the National Institutes of Health (NIH) National Cancer Institute (NCI), or by another government agency designated by FDA.  A list of EUA-authorized antibody tests and their performance characteristics is available on the FDA website.

There are a number of clinical limitations to the use of SARS-CoV-2 antibody tests.  It is not currently known how long a person may generate antibodies following an infection, or to what extent the presence of antibodies to SARS-CoV-2 indicates that a person may be protected from future infection. Also, due to the lag between infection and antibody generatin, a person may have a negative antibody test while they are infected.  For this reason, as well as possible cross-reactivity of the tests to antibodies to corona viruses other than SARS-CoC-2, the FDA recommends that antibody tests should not be used to the immediate diagnosis of a patient where COVID-19 infection is suspected.  Similarly, the American Medical Association has cautioned that antibody tests should not be offered to individuals as a method of determining immune status.



Quick Code Search

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Procedure

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Diagnosis

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Codes

      
          Full Description
            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])
      
          Full Description
            Neutralizing antibody, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]); screen
      
          Full Description
            Neutralizing antibody, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]); titer
      
          Full Description
            Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]) antibody, quantitative
      
          Full Description
            Antibody; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19])
      
          Full Description
            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])
      
          Full Description
            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
      
          Full Description
            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
      
          Full Description
            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
      
          Full Description
            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
      
          Full Description
            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])
      
          Full Description
            Cdc 2019 novel coronavirus (2019-ncov) real-time rt-pcr diagnostic panel
      
          Full Description
            2019-ncov coronavirus, sars-cov-2/2019-ncov (covid-19), any technique, multiple types or subtypes (includes all targets), non-cdc
      
          Full Description
            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
      
          Full Description
            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
      
          Full Description
            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




References

2020

American Medical Association. Serological testing for SARS-CoV-2 antibodies.  (revised May 14, 2020. Available at: https://www.ama-assn.org/delivering-care/public-health/serological-testing-sars-cov-2-antibodies .

2020

Centers for Disease Control and Prevention.  Interim Guidelines for COVID-19 Antibody Testing (updated May 23, 2020).  Available at:  www.cdc.gov/coronavirus/2019-ncov/lab/resources/antibody-tests-guidelines.html
2020

Centers for Disease Control and Prevention. Serology Testing for COVID-19.  (revised May 23, 2020).  Available at: https://www.cdc.gov/coronavirus/2019-ncov/lab/serology-testing.html.

2020

Infectious Diseases Society of America. IDSA Covid-19 Antibody Testing Primer.  (revised May 4, 2020).  Available at: https://www.idsociety.org/globalassets/idsa/public-health/covid-19/idsa-covid-19-antibody-testing-primer.pdf .
2020

 

Infectious Diseases Society of America.  Infectious Diseases Society of America Guidelines on the Diagnosis of COVID-19.  (May 6, 2020).  Available at: https://www.idsociety.org/practice-guideline/covid-19-guideline-diagnostics/ .

 
2020

U.S. Food and Drug Administration. FAQs on Testing for SARS-CoV-2.  (reviewed May 29, 2020).  Available at: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-testing-sars-cov-2

 
2020

Centers for Disease Control and Prevention.  Evaluating and Testing Persons for Coronavirus Disease 2019 (COVID-19).  (Revised May 3, 2020).  Available at:  https://www.cdc.gov/coronavirus/2019-nCoV/hcp/clinical-criteria.html 

2020

Families First Coronavirus Response Act (FFCRA), Public Law 116-127 (2020).

Revisions

12-18-2020

Added:  diagnostic testing pre-operatively is medically appropriate