COVID-19 Testing

Policy No: 137
Date of Origin: 05/18/2020
Section: Administrative
Last Reviewed: 05/01/2022
Last Revised: 05/01/2022
Approved: 05/12/2022
Effective: 06/01/2022

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

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)

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.

Direct-to-Consumer tests (DTC): Tests available without a prescription per FDA authorization or approval, where collection is self-performed, and results are interpreted by a laboratory

Over-the-Counter tests (OTC): Tests obtained without the involvement of a health care provider, do not require prescription or clinical review per FDA authorization or approval, where collection is self-performed, and the results are self-read

We cover COVID-19 viral (molecular and antigen) and antibody testing, subject to daily limitations, performed for the detection of SARS-CoV-2 or the diagnosis of the virus that causes COVID-19 and services furnished during the visit that resulted in the order for the test 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:

• Meets the requirements of the FDA authorization or approval (including but limited to age requirements)
• 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. Exception: 8 over-the-counter diagnostic tests for home use will be allowed without an order from a provider/RX per month per member for OTC tests authorized by the FDA for non-prescription in-home use.

• 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
• research purposes

• screening (e.g., travel, sports, school, camp, recreational, social requirement)

The AMA has released CPT 87913 for research-related testing. Any claim submitted with this code will be denied.

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.

Per CDC Guidelines I.C.1.g.1.f, diagnosis code Z11.52, Encounter for screening for COVID-19, is not appropriate during the COVID-19 pandemic. For encounters for COVID-19 testing, including preoperative testing, code as exposure to COVID-19 with diagnosis Z20.822 as indicated in ICD-10-CM guidelines I.C.1.g.1.e.

The following procedures may be covered as COVID-19 Diagnostic test or related service when billed with CS modifier or diagnosis Z20.822:

Over the Counter Test: K1034

COVID-19 Tests: 0202U, 0223U, 0224U, 0225U, 0240U, 0241U, 86328, 86413, 86769, 87426, 87428, 87449, 87635, 87636, 87637, 87811, U0001, U0002, U0003, U0004, U0005

Other tests: 0098U, 87275, 87276, 87279, 87280, 87400, 87420, 87501, 87502, 87503, 87631, 87632, 87633, 87634, 87804, 87807

Specimen Collection: C9803, G2023, G2024

Radiology: 71045, 71046, 71047, 71048

Other Services: 98966, 98967, 98968, 98970, 98971, 98972, 99202, 99203, 99204, 99205, 99211, 99212, 99213, 99214, 99215, 99217, 99218, 99219, 99220, 99221, 99222, 99223, 99224, 99225, 99226, 99231, 99232, 99233, 99238, 99239, 99281, 99282, 99283, 99284, 99285, 99291, 99292, 99304, 99305, 99306, 99307, 99308, 99309, 99310, 99315, 99316, 99318, 99324, 99325, 99326, 99327, 99328, 99334, 99335, 99336, 99337, 99341, 99342, 99343, 99344, 99345, 99347, 99348, 99349, 99350, 99354, 99355, 99356, 99357, 99358, 99359, 99406, 99407, 99421, 99422, 99423, 99441, 99442, 99443, 99446, 99447, 99448, 99449, 99451, 99452, 99460, 99461, 99462, 99463, 99464, 99465, 99466, 99467, 99468, 99469, 99471, 99472, 99473, 99474, 99475, 99476, 99477, 99478, 99479, 99480, 99483, 99484, 99487, 99489, 99490, 99491, 99492, 99493, 99494, 99495, 99496, 99497, 99498, 99499, G0245, G0246, G0248, G0249, G0250, G0296, G0372, G0378, G0379, G0406, G0407, G0408, G0420, G0421, G0425, G0426, G0427, G0438, G0439, G0508, G0509, G0513, G0514, G2010, G2012, G2025, G2250, G2251, G2252, G9156, Q3014

The following is required when submitting the claim:

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

Cares Act Section 3201

Family First Coronavirus Response Act section 6201 section 6001

FAQs about Families First Coronavirus Response Act and Coronavirus AID, Relief, and Economic Security Act Implementation Part 42

FAQs about Families First Coronavirus Response Act and Coronavirus AID, Relief, and Economic Security Act Implementation Part 43

FAQs About affordable Care Act Implementation Part 51, Families First Coronavirus Response Act and Coronavirus Aid, Relief, and Economic Security Act Implementation

FAQs about Families First Coronavirus Response Act and Coronavirus AID, Relief, and Economic Security Act Implementation Part 52

1. CDC Diagnostic Testing
2. CDC Overview of Testing for SARS-CoV-2
3. Claims submission for the COVID-19 test and related services
4. AMA Serological testing for SARS-CoV-2 antibodies
5. FDA Emergency Use Authorizations. In Vitro Diagnostic EUAs
6. FDA U.S. Food and Drug Administration; EUA Authorized Serology Test Performance
7. CPT Assistant April Update SARS-CoV-2 Serologic Laboratory Testing
8. ICD-10-CM Official Coding Guidelines – Supplement Coding encounters related to COVID-19 Coronavirus Outbreak, effective 2/20/2020
9. ICD-10-CM Official Coding and Reporting Guidelines, April 1, 2020 through September 30, 2020
10. CMS MLN Connects April 10, 2020
11. MLN Matters SE20011
12. U.S. Equal Employment Opportunity Commission
13. ICD-10-CM Official Coding and Reporting Guidelines October 1, 2020 through September 30, 2021
14. ICD-10-CM Official Coding and Reporting Guidelines January 1, 2021 through September 20, 2021
15. CMS MLN Matters Article Medicare Fee-For-Service Response to the Public Health Emergency on Coronavirus (COVID-19); Families First Coronavirus Response Act Waives Coinsurance and Deductibles for Additional COVID-19 Related Services
16. FDA.Gov Individual EUAs for Molecular Diagnostic Tests for SARS0CoV-2
17. FDA.Gov Individual EUAs for Antigen Diagnostic Tests for SARS0CoV-2
18. ICD-10-CM Official Coding and Reporting Guidelines April 1, 2022
19. CMS COVID OTC Tests

Correct Coding Guidelines
COVID-19 Testing, Medical Policy, LAB74
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