Antigen Testing for Rapid Detection of Coronavirus Disease 2019 (COVID-19)

POLICY NUMBER

L.2.04.446

DESCRIPTION

In late 2019, a novel coronavirus, now designated SARS-CoV-2, was identified as the cause of an outbreak of acute respiratory illness in Wuhan, China. The World Health Organization (WHO) designated the disease COVID-19 (coronavirus disease 2019). In January 2020, the WHO declared a public health emergency as epidemics grew in many countries all over the world. The public health emergency declaration for COVID-19 is scheduled to expire on May 11, 2023.

Healthcare providers receive guidance on identifying, testing, and treating patients from the Centers for Disease Control and Prevention (CDC) and local health departments. COVID-19 should be considered primarily in patients with fever and/or symptoms of acute respiratory illness (e.g. cough, difficulty breathing) who have had recent close contact with a confirmed or suspected case of COVID-19. People with COVID-19 present with a wide range of symptoms that may appear 2-14 days after exposure to the virus. The median incubation time is estimated to be 5.1 days with symptoms expected to be present within 12 days of infections. Symptoms are as follows:

• Fever

• 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 or vomiting

• Diarrhea.

Clinicians are strongly encouraged to test for other causes of respiratory illness, including influenza.

Antigen Diagnostic Testing

COVID-19 antigen diagnostic tests quickly detect fragments of proteins found on or within the virus by testing samples collected from the nasal cavity using swabs. The antigen test is designed for rapid detection of the virus that causes COVID-19. One of the main advantages of an antigen test is the speed of the test, which can provide results in minutes. However, antigen tests may not detect all active infections, as they do not work the same way as a polymerase chain reaction (PCR) test. Antigen tests are very specific for the virus, but are not as sensitive as molecular PCR tests. This means that positive results from antigen tests are highly accurate, but there is a higher chance of false negatives, so negative results do not rule out infection. With this in mind, negative results from an antigen test may need to be confirmed with a PCR test prior to making treatment decisions or to prevent the possible spread of the virus due to a false negative.

Throughout the course of the pandemic, multiple COVID-19 antigen diagnostic tests were developed and granted emergency use authorization (EUA) by the U.S. Food and Drug Administration (FDA). An EUA is a mechanism to facilitate the availability and use of medical countermeasures during public health emergencies, such as the current COVID-19 pandemic. Under an EUA, the FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life- threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives.

There are COVID-19 antigen diagnostic tests that have been authorized by the FDA through traditional premarket review pathways. For a list of all COVID-19 antigen diagnostic tests that have been cleared or granted de novo classification, see devices with product code QVF in the FDA’s medical devices databases for 510(k) and De Novo.

• 510(k) Premarket Database

• De Novo Premarket Database

Related medical policy –

• Coronavirus Disease 2019 (COVID-19) Reverse Transcription-Polymerase Chain Reaction (RT-PCR) Testing

POLICY

The use of FDA-approved COVID-19 antigen diagnostic testing using a nasopharyngeal or nasal swab specimen is medically appropriatewithin the first five days of the onset of symptoms for individuals suspected of COVID-19 by their healthcare provider based on an individualized clinical assessment in accordance with accepted standards of medical practice.

The use of COVID-19 antigen diagnostic testing not approved by the FDA is considered investigational, including any test authorized under an EUA.

The use of FDA-approved COVID-19 antigen diagnostic testing is considered not medically necessary for individuals suspected of COVID-19 if greater than five days after the onset of symptoms.

ALL other FDA-approved COVID-19 antigen diagnostic testing performed for screening purposes in asymptomatic individuals is considered not medically necessary, including but not limited to:

• individuals without symptoms identified for testing by health departments or clinicians, for any reason, including but not limited to: public health monitoring, sentinel surveillance, or screening of other asymptomatic individuals according to state and local plans

• testing performed to rule out COVID-19 infection

• testing for immunity

• screenings performed to return to work

• screenings performed to resume traveling

Any COVID-19 diagnostic tests paid for and dispersed by the Federal Government are not eligible for reimbursement.

POLICY EXCEPTIONS

Federal Employee Program (FEP) Members: All COVID-19 antigen diagnostic laboratory tests will pay at regular medical benefits.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Refer to the Blue Cross & Blue Shield of Mississippi Novel Coronavirus (COVID-19) Coding and Claims Submission Policy .

Signs, symptoms, and exposure history must be clearly documented in the medical records and available for review upon request.

Medical appropriateness is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

1. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

2. appropriate with regard to standards of good medical practice; and

3. not solely for the convenience of the Member, his or her Provider; and

4. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

08/03/2020: New policy added.

09/30/2020: Code Reference section updated to add new ICD-10 diagnosis code R51.9, effective 10/01/2020.

10/13/2020: Code Reference section updated to revise the code description for CPT code 87426, effective 10/06/2020.

12/23/2020: Code Reference section updated to add new procedure code D0604, effective 01/01/2021. Also added testing procedure codes 87811 and 87428.

10/01/2021: Code Reference section updated to add new ICD-10 diagnosis codes R05.1, R05.8, and R05.9 effective 10/01/2021.

05/01/2023: Policy updated regarding expiration of the COVID-19 public health emergency on 05/11/2023. Policy statement updated to state that only FDA-approved COVID-19 antigen diagnostic testing will be considered medically necessary, and testing not approved by the FDA will be considered investigational, including any test authorized under an EUA. Policy Exception added for FEP members. Sources updated. Code Reference section updated to remove deleted ICD-10 diagnosis codes R05 and R51. Effective 05/12/2023.

07/12/2024: Policy description revised to update related medical policies. Policy statements unchanged. Sources updated.

01/01/2026: Code Reference section updated to add new CPT code 87812.

SOURCE(S)

1. https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/testing.html

2. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2

3. FAQs About Families First Coronavirus Response Act and Coronavirus Aid, Relief, and Economic Security Act Implementation Part 43 (2020).

4. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-coronavirus-disease-2019-tests-during-public-health-emergency-revised

5. Policy for Diagnostic Tests for Coronavirus Disease-1029 During the Public Health Emergency. Federal Drug Administration.

6. Testing Blueprint: Opening Up America Again. The White House, CDC, and FDA.

7. Notice on the Continuation of the National Emergency Concerning the Coronavirus Disease 2019 (COVID-19) Pandemic. https://www.whitehouse.gov/briefing-room/presidential-actions/2023/02/10/notice-on-the-continuation-of-the-national-emergency-concerning-the-coronavirus-disease-2019-covid-19-pandemic-3/

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Medically Necessary Codes

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