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

POLICY NUMBER

L.5.01.545

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 as new information is released 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.

Direct Virus Testing

SARS-CoV-2 reverse transcription polymerase chain reaction (RT-PCR) testing detects the COVID-19 virus directly from nasopharyngeal, oropharyngeal, or nares swabs. A positive RT-PCR test for SARS-CoV-2 can be accepted as a true positive as the testing is very specific.

For initial diagnostic testing for SARS-CoV-2, the CDC recommends collecting and testing an upper respiratory specimen. Nasopharyngeal specimen is the preferred choice for swab-based SARS-CoV-2 testing. When collection of a nasopharyngeal swab is not possible, the following are acceptable alternatives:

• An oropharyngeal specimen collected by a healthcare professional, or

• A nasal mid-turbinate swab collected by a healthcare professional or by onsite self-collection (using a flocked tapered swab), or

• An anterior nares (nasal swab) specimen collected by a healthcare professional or by onsite self-collection (using a flocked or spun polyester swab)

• Nasopharyngeal wash/aspirate or nasal aspirate specimen collected by a healthcare professional

Throughout the course of the pandemic, multiple SARS-CoV-2 RT-PCR 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 SARS-CoV-2 RT-PCR diagnostic tests that have been authorized by the FDA through traditional premarket review pathways. For a list of all SARS-CoV-2 RT-PCR diagnostic tests that have been cleared or granted de novo classification, see devices with product codes QOF and QQX in the FDA’s medical devices databases for 510(k) and De Novo.

• 510(k) Premarket Database

• De Novo Premarket Database

  Related medical policy –

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

POLICY

I.  Testing of Individuals With Signs and Symptoms Compatible with COVID-19

The use of FDA-approved COVID-19 RT-PCR diagnostic testing using an upper respiratory specimen is medically appropriate for individuals with signs and symptoms compatible with COVID-19 without an alternative explanatory diagnosis (e.g., influenza). 

II.  Testing of Asymptomatic Individuals with Direct Exposure to COVID-19

The use of FDA-approved COVID-19 RT-PCR diagnostic testing using an upper respiratory specimen is medically appropriate for asymptomatic individuals with known or suspected recent exposure to COVID-19 if determined to be medically appropriate by the individual’s healthcare provider based on an individualized clinical assessment in accordance with accepted standards of medical practice. 

III.  COVID-19 Testing Prior to Elective Surgeries and Procedures

The use of FDA-approved COVID-19 RT-PCR diagnostic testing using an upper respiratory specimen is considered medically appropriate prior to elective surgeries and procedures involving the mouth, nose, oropharynx, nasopharynx, respiratory tract, gastrointestinal tract or requiring general anesthesia or monitored anesthesia care (MAC). Refer to the Mississippi State Department of Health Alert “COVID-19 Outpatient Medical Services and Elective Surgery” issued on April 24, 2020. The testing is covered as part of the Member’s preoperative evaluation and is an integral part of the surgical service.

IV.  Not Medically Necessary COVID-19 Testing

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

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

• other than stated in Section II above, 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

• screenings performed prior to elective surgeries and procedures not involving the mouth, nose, oropharynx, nasopharynx, respiratory tract, GI tract or not requiring general anesthesia or MAC.

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 RT-PCR diagnostic testing 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

03/24/2020: New policy added. Effective 02/04/2020.

04/07/2020: Code Reference section updated to add HCPCS codes G2023 and G2024, effective 03/01/2020.

05/08/2020: Policy title changed from "Coronavirus Disease 2019 (COVID-19) Testing" to "Coronavirus Disease 2019 (COVID-19) Reverse Transcription-Polymerase Chain Reaction (RT-PCR) Testing." Policy description updated regarding COVID-19 symptoms and direct virus testing. First medically necessary statement revised to state that the use of COVID-19 RT-PCR diagnostic testing using an upper respiratory specimen is considered medically necessary for individuals with signs and symptoms compatible with COVID-19 without an alternative explanatory diagnosis if one or more of the criteria are met. Added medically necessary statement regarding COVID-19 testing prior to elective surgeries and procedures. Revised policy statement to list other COVID-19 testing that is considered not medically necessary. Added statement that the use of COVID-19 RT-PCR tests not approved or validated by the FDA is considered investigational. Policy Guidelines updated regarding requirements for COVID-19 diagnostic tests per the FDA. Sources updated. Code Reference section updated to add ICD-10 diagnosis codes Z01.810, Z01.811, Z01.812, and Z01.818.

05/14/2020: Policy Exceptions updated for Federal Employee Program (FEP) members to state that COVID-19 RT-PCR diagnostic testing is covered at no member cost share when required for outpatient elective surgeries and procedures.

06/19/2020: Policy Exceptions updated for Federal Employee Program (FEP) members to state that all COVID-19 RT-PCR diagnostic testing is covered at no member cost share.

06/26/2020: Policy description updated regarding COVID-19 symptoms. First policy statement regarding testing individuals with signs and symptoms of COVID-19 revised to remove listed criteria. Added policy statement for testing asymptomatic individuals with direct exposure to COVID-19. Policy Guidelines updated regarding requirements for approved or validated COVID-19 diagnostic tests. Sources updated. Code Reference section updated to remove the Not Medically Necessary Codes table.

12/23/2020: Code Reference section updated to add new ICD-10 diagnosis codes Z11.52 and Z20.822 and new HCPCS code U0005, effective 01/01/2021. Also added testing procedure codes 87636, 87637, C9803, 0202U, 0223U, 0225U, 0240U, 0241U, U0003, and U0004.

03/18/2022: Code Reference section updated to remove CPT codes 0202U, 0223U, and 0225U.

10/13/2022: Policy reviewed. Policy statements unchanged. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity."

03/30/2023: Code Reference section updated to make note of deleted CPT codes.

05/01/2023: Policy updated regarding expiration of the COVID-19 public health emergency on May 11, 2023. Policy statement updated to state that only FDA-approved COVID-19 RT-PCR 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 updated for FEP members. Sources updated. Removed HCPCS codes G2023, G2024, U0003, U0004, and U0005. Effective 05/12/2023.

10/18/2023: Policy reviewed; no changes.

12/31/2023: Updated related medical policies.

11/07/2024: Policy reviewed; no changes.

07/18/2025: Code Reference section updated to remove deleted HCPCS code C9803.

SOURCE(S)

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

2. Mississippi State Department of Health

   https://msdh.ms.gov/msdhsite/index.cfm/14,0,420,html

3. World Health Organization https://www.who.int/emergencies/diseases/novel-coronavirus-2019

4. Policy for Diagnostic Tests for Coronavirus Disease-1029 During the Public Health Emergency. Federal Drug Administration.  https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-coronavirus-disease-2019-tests-during-public-health-emergency-revised

5. Testing Blueprint: Opening Up America Again. The White House, CDC, and FDA. https://www.whitehouse.gov/wp-content/uploads/2020/04/Testing-Blueprint.pdf

6. FAQs About Families First Coronavirus Response Act and Coronavirus Aid, Relief, and Economic Security Act Implementation Part 43 (June 23, 2020).

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

8. 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 covered if the procedure is performed according to the "Policy" section of this document.

Covered Codes

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