COVID-19 Testing - CAM 244

Description
Testing for the COVID-19 virus includes Polymerase Chain Reaction (PCR) testing and serology testing.

Policy

BlueCross BlueShield of South Carolina will cover PCR diagnostic testing for COVID-19, when ordered by a licensed, authorized health care provider for individuals who are symptomatic and are concerned about infection, for the purpose of identifying and treating active disease.
BlueCross BlueShield of South Carolina will cover antigen diagnostic testing for COVID-19, when ordered by a licensed, authorized health care provider for individuals who are symptomatic and will allow reflex to PCR testing if the antigen test is negative.
Serology (antibody) testing will be covered when medically appropriate for an individual, as determined and ordered by a individual's licensed, authorized health care provider, after an evaluation of the individual and in accordance with accepted standards of current medical practice.
Serology (antibody) testing is not to be used as a sole means of diagnosis of COVID-19 infection.
Host antibody serology testing to support a diagnosis of Multisystem Inflammatory Syndrome in Children (MIS-C) and adults meets coverage criteria.
Preoperative PCR testing with a licensed, authorized health care provider order
Serial PCR tests to determine when the infection has abated with licensed, authorized health care provider orders
The acquisition of the specimen is integral to the service and is not separately reimbursed.

Rationale
As of April 29, 2020, the Infectious Diseases Society of America (IDSA) noted several facts regarding COVID-19 (also known originally as SARS-CoV-2) testing. “The current antibody testing landscape is varied and clinically unverified, and these tests should not be used as the sole test for diagnostic decisions.” Most of the testing available has been approved by FDA with the Emergency Use Authorization (EUA) that does not require the same level of premarketing testing as would typically be required. The specificity and sensitivity of current tests is quite variable. The IDSA notes, “A ‘positive’ test is exceptionally difficult to interpret because the performance of these tests is not well known.

“Further, until more evidence about protective immunity is available, serology (antibody) results should not be used to make staffing decisions or decisions regarding the need for personal protective equipment.”

The current CDC recommendation notes, “If you test positive, it is unclear if those antibodies can provide protection (immunity) against getting infected again. This means that we do not know currently if antibodies make you immune to the virus. If you have symptoms and meet other guidelines for testing, you would need another type of test called a nucleic acid test. A serologic test alone cannot tell if you definitively have COVID-19. If you test negative, some people may take even longer to develop antibodies, and some people may not develop antibodies at all.”

As noted above, FDA has approved through EUA several antibody tests. It has not approved any direct-to-consumer testing and is concerned about the potential for inaccurate testing results from direct-to-consumer testing. Any testing a member considers should be prescribed with the knowledge and follow-up of a licensed, authorized healthcare provider .

Currently IDSA believes, “antibody tests will be most useful as surveillance tools to estimate (with surrounding confidence intervals) relative proportions of different populations that have been exposed to SARS-CoV-2. They will have less utility as diagnostic tools for individual patient assessment.”

“Unlike molecular tests for COVID-19 (e.g., PCR), antibody tests may be better suited for public health surveillance and vaccine development than for diagnosis.” Additionally, the IDSA believes antibody testing will be important in identifying convalescent plasma donors and potentially in verifying vaccine response once the appropriate antibody correlates are identified.

The World Health Organization, IDSA and CDC all concur that antibody testing currently has too many variables and unknown performance characteristics to be used as the sole method of either establishing a diagnosis of COVID-19 or confirming immunity. The true rate of cross-reactivity of antibodies from COVID-19 infections to those antibodies produced by other coronaviruses is unknown. There are several parts of a coronavirus that can produce antibodies. Which ones are most accurate for predicting recovery and immunity is currently unknown. It is not known what level of antibodies in a person’s bloodstream is needed to provide immunity, get rid of the virus, and prevent reinfection. This is important, as individuals who have had a mild case of COVID-19 and initially recover may not develop enough antibody to prevent a future COVID-19 infection. If antibodies prove to provide immunity, it is not currently known how long that immunity will last.

There are two types of antibody tests. One is identified as Rapid Detection Testing. It is a qualitative test and is very similar to a pregnancy test. The result is either positive, negative or inconclusive, but there is no information in the result about how much antibody a person may have. The second testing type is Enzyme-Linked Immunosorbent Assay (ELISA). This is a quantitative test. The patient’s antibodies to COVID-19 are mixed with a colored substrate that binds to the antibodies. The result is read with a special instrument that can identify very minor variations in color. The more intense the color the more COVID-19 antibody is present. Only this second test can identify the level of antibody a person has but as noted above, it is not currently known what level of antibody is needed protect the person from getting infected again by COVID-19.

At this time, CDC is not recommending testing for return to work, except use of SARS-CoV-2 RNA testing (NOT antibody testing) as part of an optional test-based strategy for health care workers who are confirmed or suspected of previously having COVID-19. The CDC criteria for laboratory testing notes that the decision for testing should be made by a clinician on a patient-by-patient basis and that testing should be performed on symptomatic patients. It notes, however, that "persons without symptoms in certain situations" might be considered for testing. The Federal Department of Labor OSHA guidance for preparing workplaces for COVID-19 does NOT include antibody or antigen testing in its guidance for the workplace.

The CDC notes that with a positive antibody test for COVID-19, "it’s unclear if those antibodies can provide protection (immunity) against getting infected again." A negative antibody test could mean you have a current infection and could still spread the virus and CDC specifically notes: "these test results alone do not confirm if you are able to spread the virus that causes COVID-19." As such, we do not feel that it is in the best interest of the workforce or public health to promote and perform these tests except on a case-by-case basis with decisions made by a clinician actively caring for the patient.

References

FDA. Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency. 2020; https://www.fda.gov/media/135659/download. Accessed 4/21/2020.
Infectious Diseases Society of America. IDSA COVID-19 Antibody Testing Primer, updated April 29, 2020.
CDC. Coronoavirus Disease 2019 (COVID-19); https://www.cdc.gov/coronavirus/2019-ncov/faq.html. Accessed 5/4/2020.

Coding Section

Code	Number	Description
CPT	86328	severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease (COVID-19))
	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
	86769	Antibody; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease (COVID-19))
	87426	Infectious agent antigen detection by immunoassay technique, (eg, enzyme immunoassay [EIA], enzyme-linked immunosorbent assay [ELISA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative, multiple-step method; severe acute respiratory syndrome coronavirus (eg, SARS-CoV, SARS-CoV-2 (COVID-19)).
	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.
	87631	Infectious agent detection by nucleic acid (DNA or RNA); respiratory virus (eg, adenovirus, influenza virus, coronavirus, metapneumovirus, parainfluenza virus, respiratory syncytial virus, rhinovirus), includes multiplex reverse transcription, when performed, and multiplex amplified probe technique, multiple types of subtypes, 3-5 targets
	87632	Infectious agent detection by nucleic acid (DNA or RNA); respiratory virus (eg, adenovirus, influenza virus, coronavirus, metapneumovirus, parainfluenza virus, respiratory syncytial virus, rhinovirus), includes multiplex reverse transcription, when performed, and multiplex amplified probe technique, multiple types of subtypes, 6-11 targets
	87633	Infectious agent detection by nucleic acid (DNA or RNA); respiratory virus (eg, adenovirus, influenza virus, coronavirus, metapneumovirus, parainfluenza virus, respiratory syncytial virus, rhinovirus), includes multiplex reverse transcription, when performed, and multiplex amplified probe technique, multiple types of subtypes, 12-25 targets
	87635	Infectious agent detection by nucleic acid (DNA or RNA); severe acute respirator syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease (COVID-19), amplified probe technique
	87636	Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease (COVID-19)) and influenza virus types A and B, multiplex amplified probe technique
	87637	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
	87811	Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease (COVID-19))
	0098U (Deleting Code effective 01/01/2022)	Respiratory pathogen, multiplex reverse transcription and multiplex amplified probe technique, multiple types or subtypes, 14 targets (adenovirus, coronavirus, human metapneumovirus, influenza A, influenza A subtype H1, influenza A subtype H3, influenza A subtype H1-2009, influenza B, parainfluenza virus, human rhinovirus/enterovirus, respiratory syncytial virus, Bordetella pertussis, Chlamydophila pneumoniae, Mycoplasma pneumoniae)
	0099U (Deleting Code effective 01/01/2022)	Respiratory pathogen, multiplex reverse transcription and multiplex amplified probe technique, multiple types or subtypes, 20 targets (adenovirus, coronavirus 229E, coronavirus HKU1, coronavirus, coronavirus OC43, human metapneumovirus, influenza A, influenza A subtype, influenza A subtype H3, influenza A subtype H1-2009, influenza, parainfluenza virus, parainfluenza virus 2, parainfluenza virus 3, parainfluenza virus 4, human rhinovirus/enterovirus, respiratory syncytial virus, Bordetella pertussis, Chlamydophila pneumonia, Mycoplasma pneumoniae)
	0100U (Deleting Code effective 01/01/2022)	Respiratory pathogen, multiplex reverse transcription and multiplex amplified probe technique, multiple types or subtypes, 20 targets (adenovirus, coronavirus 229E, coronavirus HKU1, coronavirus NL63, coronavirus OC43, human metapneumovirus, human rhinovirus/enterovirus, influenza A, including subtypes H1, H1-2009, and H3, influenza B, parainfluenza virus 1, parainfluenza virus 2, parainfluenza virus 3, parainfluenza virus 4, respiratory syncytial virus, Bordetella parapertussis [IS1001], Bordetella pertussis [ptxP], Chlamydia pneumoniae, Mycoplasma pneumoniae)
	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
	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
	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
	0241U	Infectious disease (viral respiratory tract infection), pathogen-specific RNA, 4 targets (severe acute respiratory syndrome coronavirus (SARS-CoV-2), influenza A, influenza B, respiratory syncytial virus (RSV)), upper respiratory specimen, each pathogen reported as detected or not detected
	0224U	Antibody, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease (COVID-19), includes titer(s), when performed (Do not report 0224U in conjunction with 86769)
HCPCS	U0001	CDC 2019 NOVEL CORONAVIRUS (2019-NCOV) REAL-TIME RT-PCR DIAGNOSTIC PANEL
	U0002	2019-ncov coronavirus, sars-cov-2/2019-ncov (covid-19), any technique, multiple types or subtypes (includes all targets), non-cdc
	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
	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
ICD-10 CM	J12.82	Pneumonia due to coronavirus disease 2019
	M35.81	Multisystem inflammatory syndrome
	M35.89	Other specified systemic involvement of connective tissue
	Z03.818	Encounter for observation for suspected exposure to other biological agents rulled out.
	Z20.828	CONTACT WITH AND (SUSPECTED) EXPOSURE TO OTHER VIRAL COMMUNICABLE DISEASES
	Z11.52	Encounter for screening for COVID-19
	Z11.59	Encounter for screening for other viral diseases
	Z20.822	Contact with and (suspected) exposure to COVID19
	Z86.16	Personal history of COVID-19
	B9729	Other coronavirus as the cause of diseases classified elsewhere
	U071	COVID-19

CODING NOTE:
Prior to Jan. 1, 2021, codes Z11.59,Z03.818 and Z20.828 would have been appropriately used to indicate COVID-19 contact or exposure. After Jan. 1, 2021, code Z20.822 would be the appropriate code to indicate contact with and suspected exposure to COVID-19.

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross Blue Shield Association technology assessment program (TEC) and other non-affiliated technology evaluation centers, reference to federal regulations, other plan medical policies, and accredited national guidelines.

History From 2019 Forward

05/02/2022	Annual review, no change to policy intent.
11/29/2021	Updating policy with 2022 coding. DELETING code 0098U, 0099U and 0100U effective 01/01/2022
05/05/2021	Annual review, no change to policy intent.
03/17/2021	Interim review, removing verbiage related to asymptomatic PCR testing.
03/12/2021	Interim review to update : “attending healthcare provider” to “licensed, authorized healthcare provider". No other changes.
02/09/2021	Interim review adding coding note: Prior to 01012021, codes Z11.59,Z03.818 and Z20.828 would have been appropriately used to indicate COVID contact or exposure. After 01012021 code Z20.822 would be the appropriate code to indicate contact with and suspected exposure to COVID.
02/02/2021	Correcting Coding. Code 87428 was listed twice. No other Changes made.
01/27/2021	Adding Codes U0001, U0002, U0003 and U0004 to coding section. No other changes.
12/15/2020	Correction made to code "0244U."
12/11/2020	Updating coding to include: 86408, 86409, 87428, J12.82, M35.81, M35.89, Z11.52, Z20.822, and Z86.16
10/23/2020	Interim review, adding policy verbiage for adult coverage of testing for Multisystem Inflammatory Syndrome.
10/09/2020	Update coding. Adding codes 87636, 87637, 87811, 0240U, 0241U. No other changes made.
09/14/2020	Update coding. Adding code 86413 to coding section. No other changes made.
08/25/2020	Interim review, updating verbiage regarding PCR testing, adding verbiage regarding antigen testing, adding verbiage regarding specimen acquisition, and removing G2023 and G2024 from coding.
07/01/2020	Interim review to add new coding to coding grid: 87426, 0223U and 0224U.
06/18/2020	Interim review to add coverage for PCR testing in the following individuals: asymptomatic members exposed to persons with known COVID-19, preoperative testing and serial testing to determine when the infection has abated.
06/11/2020	Interim review to add: Host antibody serology testing to support a diagnosis of Multisystem Inflammatory Syndrome in Children (MIS-C) meets coverage criteria. No other changes made.
06/09/2020	Corrected typo in last paragraph. No other changes.
05/28/2020	Adding code 0202U to the coding section. No other changes made.
05/15/2020	Updated coding
05/06/2020	New Policy

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COVID-19 Testing - CAM 244