Testing for SARS-CoV-2 (Coronavirus Disease 2019 (COVID-19)) for Independence Commercial Members - Updated May 13, 2020




    Purpose

    The purpose of this News Article is to provide advance notice regarding information and procedure and diagnosis codes related to testing for SARS-CoV-2 (Coronavirus Disease 2019 (COVID-19)).

    This News Article addressing Testing for SARS-CoV-2 (Coronavirus Disease 2019 (COVID-19)) is effective from March 6, 2020 through December 31, 2020, or the duration of the public health emergency.

    Note: Information related to SARS-CoV-2 (Coronavirus Disease 2019 (COVID-19)) is continuously evolving. The Company is closely monitoring the outbreak caused by the novel coronavirus, and will update our communications accordingly.



    Background

    There is currently an outbreak of respiratory disease caused by a novel coronavirus, which has now been detected both nationally and internationally. The virus has been named “SARS-CoV-2” and the disease it causes has been named “Coronavirus Disease 2019” (COVID-19). To effectively respond to the COVID-19 outbreak, rapid detection of cases and contacts, appropriate clinical management and infection control, and implementation of community mitigation efforts are critical.


    Centers for Disease Control and Prevention COVID-19 Testing

    The Centers for Disease Control and Prevention (CDC) has developed a new laboratory test kit for use in testing patient specimens for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19. The test kit is called the Centers for Disease Control and Prevention (CDC) 2019-Novel Coronavirus (2019-nCoV) Real-Time Reverse Transcriptase (RT)-PCR Diagnostic Panel. CDC’s test kit is intended for use by laboratories designated by CDC as qualified, and, in the United States, certified under the Clinical Laboratory Improvement Amendments (CLIA) to perform high-complexity tests. This test is approved through the Emergency Use Authorization (EUA) processes of the U.S. Food and Drug Administration (FDA).


    Emergency Use Authorizations (EUA) by FDA for COVID-19 Diagnostic Testing (RT-PCR and Antigen Testing) and Antibody Testing

    Diagnostic Tests

    RT-PCR

    Recognizing the emergent circumstances related to this virus, the FDA has issued guidance to provide a policy for COVID-19 molecular diagnostics tests (e.g., RT-PCR) developed by laboratories certified to perform high-complexity testing under CLIA prior to issuance of Emergency Use Authorizations (EUA) for such tests. For a reasonable period of time after validation, and while they are preparing their EUA requests, the FDA does not intend to object to the use of these tests for specimen testing. This FDA EUA Process for COVID-19 testing includes certain diagnostic lab tests that use high-throughput technologies to rapidly diagnose large numbers of 2019 Novel Coronavirus (COVID-19) cases. Among several other technical, analytic, and clinical COVID-19 diagnostic RT-PCR test performance requirements, FDA requires high levels of positive percent agreement (PPA)/sensitivity and negative percent agreement (NPA)/specificity. These parameters, generally, do not have a lower range below percentages in the nineties.

    Antigen Tests

    There is FDA EUA issuance for COVID-19 antigen testing, which is a category of diagnostic tests to detect fragments of proteins found on or within the virus. Among several other technical, analytic, and clinical COVID-19 diagnostic antigen test performance requirements, FDA requires antigen tests should demonstrate a minimum sensitivity of ≥ 80% for all sample types submitted.

    Serology Tests (Antibody Tests)

    These EUAs by the FDA also include serology testing to determine COVID-19 status from antibodies in blood samples (e.g., immunoglobulin G/immunoglobulin M (IgG/IgM), and includes rapid testing to detect antibodies against SARS-CoV-2 in serum, plasma, or venipuncture whole blood). FDA details several requirements for the clinical agreement studies, for COVID-19 serological tests, which are intended to establish the performance characteristics for this antibody testing. Among several other technical, analytic, and clinical COVID-19 antibody test performance requirements, FDA requires a minimum overall 90.0% PPA/sensitivity and overall 95.0% NPA/specificity. FDA specifies other required values for each antibody type and combined parameters as well.


    CDC Recommendations for Specimen Collection for Diagnostic COVID-19 Testing

    For initial diagnostic testing for COVID-19, CDC recommends collecting and testing an upper respiratory nasopharyngeal swab (NP). Collection of oropharyngeal swabs (OP) is a lower priority and, if collected, should be combined in the same tube as the NP. Collection of only OP swab is acceptable if other swabs are not available. Collection of sputum should only be done for those patients with productive coughs. Induction of sputum is not recommended. CDC also recommends testing lower respiratory tract specimens, if available. For individuals who develop a productive cough, sputum should be collected and tested for SARS-CoV-2. For individuals for whom it is clinically indicated (e.g., those receiving invasive mechanical ventilation), a lower respiratory tract aspirate or bronchoalveolar lavage sample should be collected and tested as a lower respiratory tract specimen. Specimens should be collected as soon as possible once an individual under investigation is identified, regardless of the time of symptom onset. Note that individual commercial lab tests may require collection of only one specimen type for initial diagnostic testing (nasopharyngeal OR oropharyngeal). For updated information go to: https://www.cdc.gov/coronavirus/2019-ncov/lab/guidelines-clinical-specimens.html.


    At-Home Self-Sample Collection for COVID-19 Diagnostic Test

    The FDA has begun authorizing diagnostic testing with a home specimen self-sample collection option for COVID-19. These self-collected samples must be tested and processed at approved laboratories for COVID-19 testing that is being performed within the FDA EUA guidance. As an example, the FDA re-issued the emergency use authorization (EUA) for the Laboratory Corporation of America (LabCorp) COVID-19 RT-PCR Test to permit testing of nasal swab samples self-collected by patients at home using LabCorp’s Pixel by LabCorp COVID-19 Test home collection kit.

    There is FDA EUA issuance that permits testing of saliva samples self-collected by patients at home using the FDA authorized COVID-19 diagnostic testing, which uses saliva samples to test for this virus in a healthcare setting.

    The FDA’s position is at-home processing tests cannot be utilized without an EUA for regulatory reasons outside of the scope of the Coronavirus Aid, Relief, and Economic Security (CARES) Act.


    Home Test Kits (Rapid or Instant Tests)

    The FDA has not approved any COVID-19 test to be completely collected and processed at home (e.g., rapid or instant tests). Any COVID-19 test intended for complete at-home testing requires an FDA-authorized EUA and cannot be performed prior to receiving this authorization.


    Differential Diagnosis

    Because the signs and symptoms of the early stages of the COVID-19 disease are nonspecific, the differential diagnosis of COVID-19 infection may include the possibility of a range of common respiratory disorders, including:
    • Adenovirus
    • Influenza
    • Human metapneumovirus (HmPV)
    • Parainfluenza
    • Respiratory syncytial virus (RSV)
    • Rhinovirus (common cold)

    For suspected cases, ruling out other common respiratory pathogens may be necessary.



    Indications

    N/A



    Coverage Statement

    The Company follows federal, state and local regulatory guidance related to COVID-19 testing. COVID-19 tests will only be covered when ordered by a healthcare professional licensed and/or authorized to do so under state law.


    SPECIMENS COLLECTED BY A HEALTHCARE PROFESSIONAL:


    COVID-19 Testing (Diagnostic RT-PCR and Antigen Tests and Antibody Tests)

    The Company will cover (i) certain COVID-19 tests (diagnostic RT-PCR and antigen tests, and antibody tests), including COVID-19 tests that have been approved, cleared, or authorized by the FDA or for which the developer has requested, or intends to request, Emergency Use Authorization (EUA) for the COVID-19 pandemic; and (ii) the administration of such tests, when ordered by a licensed health care provider and performed at an approved healthcare setting. (This includes drive through testing). Such testing will only be covered if medically appropriate as determined by the member’s health care provider in accordance with accepted standards of current medical practice. We recommend that health care providers confirm with Company if such lab is an authorized and/or contracted lab and if they have the ability to perform such testing.

    A developer’s COVID-19 diagnostic or antibody test kit will be considered non-covered unless (i) the FDA approves the test for use; (ii) the developer has submitted an Emergency Use Authorization application (EUA) to the FDA for approval during the time of the public health emergency (or intends to do so within a reasonable period of time, which is currently 15 days for RT-PCR and antigen tests and 10 days for serology (antibody tests)*; or (iii) the test was developed in and authorized by a State that has notified the Secretary of Health and Human Services of its intention to review tests intended to diagnose COVID-19.

    *FDA expects commercial manufacturers to submit Emergency Use Authorization (EUA) requests, including their validation data, within 10 days of publication of the updated policy or the date they notify FDA of their test validation, whichever is later.

    If the FDA denies an EUA application for a COVID-19 diagnostic or antibody test or the test’s developer fails to timely submit the EUA to the FDA for approval, the test will no longer be covered.

    A diagnostic or antibody COVID-19 test will not be covered if does not meet the requirements, including technical, analytic, and clinical performance measures, detailed by the FDA in the most recent version of Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency -- Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff.

    Authorized labs must notify local public health authorities before initiating testing with a COVID-19 diagnostic or antibody test kit, follow the terms and conditions described in the applicable EUA for an approved at-home diagnostic or antibody test kit, and administer the test in accordance with the applicable test procedures referenced therein.

    Lab specimens for members enrolled in HMO and HMO-POS products may need to be sent to a different in-network approved laboratory, which is not the member's designated capitated laboratory site, when the designated capitated laboratory site does not have the ability to perform the COVID-19 test.

    Referral and out of capitation authorization requirements have been waived for COVID-19 Laboratory Testing HCPCS codes U0001, U0002, U0003, U0004, G2023, G2024, and CPT codes 86328, 86769, and 87635.

    Laboratory Corporation of America® Holdings (LabCorp), the national outpatient laboratory provider for the Company, is equipped to process diagnostic (RT-PCR) and antibody (IgG) COVID-19 specimen testing for our members. Details are available on the LabCorp website available at


    Laboratory Testing for COVID-19 Differential Diagnosis

    The Company will cover testing of other clinically relevant respiratory pathogens, for the differential diagnosis of COVID-19. These tests include testing of the following pathogens through any clinically established method:
    • Adenovirus
    • Influenza
    • Human metapneumovirus (HmPV)
    • Parainfluenza
    • Respiratory syncytial virus (RSV)
    • Rhinovirus (common cold)

    Referral and out of capitation authorization requirements have also been waived for COVID-19 Differential Diagnosis Laboratory Testing procedure codes when performed in conjunction with COVID-19 Laboratory Testing.


    SPECIMENS COLLECTED BY A MEMBER:

    Testing of Samples Self-Collected by Members at Home

    The Company will cover testing of samples self-collected by members at home when the testing will be processed at an approved laboratory following FDA EUA Guidance, and self-collection materials (including kits) have received specific FDA EUA approval.
    • For example, the FDA re-issued the Emergency Use Authorization (EUA) for the Laboratory Corporation of America (LabCorp) COVID-19 RT-PCR Test to permit testing of samples self-collected by members at home using LabCorp’s Pixel by LabCorp COVID-19 Test home collection kit.


    Home Tests (Rapid or Instant Tests)

    At the present time the FDA has not approved any COVID-19 test to be completely used and processed at home (i.e., rapid or instant tests) to detect and diagnose COVID-19. Until such time that the FDA has granted approval the Company does not cover COVID-19 home tests.


    ROUTINE COVID-19 TESTING IN ADVANCE OF PROCEDURES

    Reimbursement for routine COVID-19 laboratory testing, for asymptomatic and/or nonexposed individuals, (e.g., preadmission testing; screening prior to procedures as part of an institutional protocol) is reimbursed as part of the procedural or surgical payment and is not eligible for separate reimbursement.



    Dosing and Administration

    N/A



    Black Box Warnings and/or Contraindications

    N/A



    Coding


    DIAGNOSTIC TESTING FOR COVID-19

    HCPCS codes U0001 and U0002, representing CDC and non-CDC testing, respectively, for SARS-CoV-2 (COVID-19) are effective and must be used for dates of service as of February 4, 2020 and after.

    • 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

      Note: HCPCS code U0002 applies to all types of COVID-19 laboratory testing (e.g., RT-PCR).


    HCPCS codes U0003 and U0004, for SARS-CoV-2 (COVID-19) laboratory testing using high throughput technologies, are effective and must be used for dates of service as of April 14, 2020 and after.

    • 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


    CPT code 87635 for SARS-CoV-2 (COVID-19) nucleic acid testing is effective and must be used for dates of service as of March 13, 2020 and after.


    ANTIBODY TESTING FOR COVID-19

    CPT codes 86328 and 86769 for SARS-CoV-2 (COVID-19) antibody testing are effective and must be used for dates of service as of April 10, 2020 and after.


    SPECIMEN COLLECTION BY A HEALTHCARE PROFESSIONAL FOR COVID-19

    HCPCS codes C9803, G2023 and G2024 for collection of SARS-CoV-2 (COVID-19) specimens, including nasopharyngeal swab (NP), oropharyngeal swabs (OP), serum, plasma, or venipuncture whole blood, are effective and must be used for dates of service as of March 1, 2020 and after.

    • C9803: Hospital outpatient clinic visit specimen collection for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]), any specimen source

    • G2023: Specimen collection for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), any specimen source

    • G2024: Specimen collection for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), from an individual in a skilled nursing facility or by an approved laboratory on behalf of a home health agency, any specimen source


    LABORATORY TESTING FOR COVID-19 DIFFERENTIAL DIAGNOSIS

    • 86603, 86710, 86756, 87260, 87275, 87276, 87279, 87280, 87301, 87400, 87420, 87501, 87502, 87503, 87631, 87632, 87633, 87634, 87804, 87807, 87809


    SPECIMEN COLLECTION FOR COVID-19 DIFFERENTIAL DIAGNOSIS LABORATORY TESTING

    • S9529, 36400, 36405, 36406, 36410, 36415, 36425, 36420


    ICD-10 DIAGNOSIS CODING FOR COVID-19

    Effective April 1, 2020, claims for members diagnosed with an illness confirmed as due to the 2019 novel coronavirus SARS-CoV-2 (COVID-19) should be reported with the following diagnosis code:

    • U07.1: 2019-nCoV acute respiratory disease

      Note: Presumptive positive COVID-19 test results should be coded as confirmed.


    For claims prior to April 1, 2020, for members diagnosed with an illness confirmed as due to the 2019 novel coronavirus SARS-CoV-2 (COVID-19) should be reported with the following diagnosis code:

    • B97.29: Other coronavirus as the cause of diseases classified elsewhere


    Claims for members who have a possible or known exposure to someone confirmed with having COVID-19 should be reported with the following diagnosis codes:

    • Z03.818, Encounter for observation for suspected exposure to other biological agents ruled out

    • Z20.828: Contact with and (suspected) exposure to other viral communicable diseases


    Claims for members who are asymptomatic and had no known exposure to the COVID-19 virus, and for whom test results are either unknown or negative, should be reported with the following diagnosis code:

    • Z11.59: Encounter for screening for other viral disease


    Claims for members who present with signs or symptoms but have not been confirmed as having COVID-19 and have no known exposure to COVID-19 should be reported with the appropriate sign or symptom diagnosis code. For example:

    • R05: Cough
    • R06.02: Shortness of breath
    • R50.9: Fever, unspecified
    • R68.89: Other general symptoms and signs


    The Company may conduct reviews and audits of services to our members regardless of the participation status of the provider. Medical record documentation must be maintained on file to reflect the medical necessity of the care and services provided. This includes verification that laboratory or home test kits have been approved, cleared, or authorized by the FDA and/or that the developer has adequately abided by the FDA guidance before and after formally requesting EUA for the COVID-19 testing, including – but not limited to – test validation standards, reporting requirements, clinical testing to establish acceptable performance characteristics, and timeline adherence.



    Issued on - 05/13/2020

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