There is currently an outbreak of respiratory disease caused by a novel coronavirus, which has 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 THE FDA for COVID-19 Diagnostic Testing (RT-PCR and Antigen Testing) and Antibody Testing
Diagnostic testing for SARS-CoV-2 is intended to identify occurrence at the individual level and is performed when there is a reason to suspect that an individual may be infected, such as having symptoms or suspected recent exposure, or to determine resolution of infection.
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, the 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.
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, the 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). The 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, the FDA requires a minimum overall 90.0% PPA/sensitivity and overall 95.0% NPA/specificity. The 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)
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 DiagnosisBecause 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:
For suspected cases, ruling out other common respiratory pathogens may be necessary. PUBLIC HEALTH SURVIELLANCE AND SCREENING FOR COVID-19 Public Health Surveillance Surveillance for SARS-CoV-2 includes ongoing systematic activities, including collection, analysis, and interpretation of health-related data that are essential to planning, implementing, and evaluating public health practice. Surveillance testing is generally used to monitor for a community- or population-level occurrence, such as an infectious disease outbreak, or to characterize the occurrence once detected, such as looking at the incidence and prevalence of the occurrence. Surveillance testing is used to gain information at a population level, rather than an individual level, and results of surveillance testing can be returned in aggregate to the requesting institution. Surveillance testing may sample a certain percentage of a specific population to monitor for increasing or decreasing prevalence and to determine the population effect from community interventions, such as social distancing. An example of surveillance testing is a plan developed by a state public health department to randomly select and sample a percentage of all individuals in a city on a rolling basis to assess local infection rates and trends. Screening Screening tests for SARS-CoV-2 are intended to identify occurrence at the individual level even if there is no reason to suspect infection—e.g., there is no known exposure. This includes, but is not limited to, screening of non-symptomatic individuals without known exposure with the intent of making decisions based on the test results. Screening tests are intended to identify infected individuals without, or prior to development of, symptoms who may be contagious so that measures can be taken to prevent further transmission. Examples of screening include testing plans developed by a workplace to test its employees, and testing plans developed by a school to test its students, faculty, and staff. In both examples, the intent is to use the screening testing results to determine who may return and the protective measures that will be taken.
- Human metapneumovirus (HmPV)
- Respiratory syncytial virus (RSV)
- Rhinovirus (common cold)
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
Diagnostic COVID-19 Testing (RT-PCR or Antigen Tests)
The Company will cover (i) certain diagnostic COVID-19 tests (diagnostic RT-PCR and antigen 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 the Company if such lab is an authorized and/or contracted lab and if they have the ability to perform such testing. Diagnostic COVID-19 testing will be covered for:
- Individuals with signs or symptoms consistent with COVID-19
- Asymptomatic individuals with recent known or suspected exposure to SARS-CoV-2 to control transmission
When ordered by a healthcare provider, the Company will cover medically necessary diagnostic pooled testing only for testing that is associated with Company members' samples.
Antibody COVID-19 Testing
The Company will cover (i) certain antibody COVID-19 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 the Company if such lab is an authorized and/or contracted lab and if they have the ability to perform such testing. Currently, antibody testing for COVID-19 has clinical support in these scenarios, and will be covered when:
- Antibody tests are used to support the clinical assessment of COVID-19 illness for individuals who are being tested 9 to 14 days after illness onset, in addition to recommended virus detection methods such as PCR. This may maximize sensitivity as the sensitivity of nucleic acid detection is decreasing and serologic testing is increasing during this time period.
- Antibody testing is being used to help establish a clinical picture when individuals have late complications of COVID-19 illness, such as multisystem inflammatory syndrome in children.
- Neutralizing antibody screening and titer testing, and surrogate viral neutralization testing are used exclusively for the purpose of convalescent plasma administration during a hospital admission at the decision of the individual's medical providers.
Antibody test results should not be used to diagnose someone with an active infection.
REQUIREMENTS REGARDING FDA AUTHORIZATIONS FOR COVID-19 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.
*The 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 the 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, U0005, G2023, G2024, and CPT codes 0202U, 0223U, 0224U, 0225U, 0226U, 0240U, 0241U, 86328, 86408, 86409, 86413, 87428 , 86769, 87246, 87635, 87636, 87637, and 87811.
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 DiagnosisThe 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:
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. SPECIMEN COLLECTED BY AN AUTHORIZED WORKER FROM HOME HEALTH AGENCIES To help reduce potential exposure of COVID-19, the Company is waiving the requirement that a member be homebound for the purpose of laboratory specimen collection for diagnostic COVID-19 testing in their home. In response to the COVID-19 outbreak, home specimen collection for diagnostic COVID-19 and related diagnostic respiratory pathogens' testing is considered medically necessary and, therefore, covered when all of the following criteria are met:
- Human metapneumovirus (HmPV)
- Respiratory syncytial virus (RSV)
- Rhinovirus (common cold)
- The specimen is collected by a nurse from a home health agency or by a trained laboratory technician.
- The requirement that a member must be homebound (as defined in the medical policy) is waived, in order to receive a nurse visit from a home health agency for the purpose of laboratory specimen collection for COVID-19 testing in their home.
- The specimen collection is medically necessary for the individual's condition and has been ordered by an eligible professional provider.
- The specimen will be delivered to the appropriate Company participating laboratory to perform the test and send the results to the prescribing professional provider.
SPECIMENS COLLECTED BY A MEMBER:
Testing of Samples Self-Collected by Members
The Company will cover testing of samples self-collected by members a when the testing is 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. 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. Testing of Nursing Home Residents and Patients
Based on the evolving recommendations from the CDC for Testing Guidelines for Nursing Homes, (https://www.cdc.gov/coronavirus/2019-ncovs/hcp/nursing-homes-testing.html), Centers for Medicare & Medicaid Services (CMS) has issued communications for COVID-19 testing for nursing home residents and patients.
Reimbursement of routine COVID-19 testing in these contexts is reimbursed as part of the per diem payment to the facility and is not eligible for separate reimbursement for members admitted to skilled nursing facilities for short-term medical or rehabilitation purposes.
PUBLIC HEALTH SURVELLIANCE AND SCREENING
The Company does not cover COVID-19 testing when the primary purpose of this testing is for public health surveillance and/or screening. This includes tests using pooling methodologies or any others with a current FDA EUA.
The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.
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. This also includes review of any tests whose EUA has been revoked by the FDA.
All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.
Eligible professional providers performing diagnostic pooled SARS-CoV-2 (COVID-19) laboratory testing must report the most appropriate procedure code to represent the method of testing used and only one unit of service for each of the Company's members tested.
DIAGNOSTIC TESTING FOR COVID-19 (e.g., through RT-PCR)
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
HCPCS code U0005 for SARS-CoV-2 (COVID-19) laboratory testing using high throughput technologies, completed within 2 calendar days from date of specimen collection, is effective and must be used for dates of service as of January 01, 2021 and after.
- U0005: 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, cdc or non-cdc, making use of high throughput technologies, completed within 2 calendar days from date of specimen collection (list separately in addition to either hcpcs code U0003 or U0004) as described by CMS-2020-01-R2
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.
CPT code 0202U for BioFire® Respiratory Panel 2.1 (RP2.1) testing manufactured by BioFire® Diagnostics, LLC is effective and must be used for dates of service as of May 20, 2020 and after.
CPT codes 0223U for QIAstat-Dx Respiratory SARS CoV-2 Panel testing manufactured by QIAGEN Sciences is effective and must be used for dates of service as of June 25, 2020 and after.
CPT code 0225U for ePlex® Respiratory Pathogen Panel 2 developed by GenMark Diagnostics, Inc. is effective and must be used for dates of service as of August 10, 2020 and after.
CPT codes 0240U, 0241U, 87636, and 87637 for SARS-CoV-2 (COVID-19) and other respiratory pathogens' nucleic acid testing are effective and must be used for dates of service as of October 06, 2020 and after.
DIAGNOSTIC ANTIGEN TESTING FOR COVID-19
CPT code 87426 for infectious agent antigen detection by immunoassay technique of SARS-CoV and/or SARS-CoV-2 is effective and must be used for dates of service as of June 25, 2020 and after.
CPT code 87811 for SARS-CoV-2 (COVID-19) antigen testing by immunoassay with direct optical observation is effective and must be used for dates of service as of October 06, 2020 and after.
CPT code 87428 for SARS-CoV-2 (COVID-19) and other respiratory pathogens' antigen testing through an immunoassay technique is effective and must be used for dates of service as of November 09, 2020 and after.
ANTIBODY TESTING FOR COVID-19
CPT codes 86328 and 86769 for SARS-CoV-2 (COVID-19) qualitative or semiquantitative antibody testing are effective and must be used for dates of service as of April 10, 2020 and after.
CPT code 0224U for SARS-CoV-2 (COVID-19) antibody testing developed by Mt. Sinai Laboratory is effective and must be used for dates of service as of June 25, 2020 and after.
CPT codes 86408 and 86409 for SARS-CoV-2 (COVID-19) neutralizing antibody screening and titer testing respectively are effective and must be used for dates of service as of August 10, 2020 and after.
CPT code 0226U for Tru-Immune, a serological test that measures and also quantifies the neutralizing capacity of antibodies against the SARS-CoV-2, by Ethos Laboratories and GenScript® USA Inc. is effective and must be used for dates of service as of August 10, 2020 and after.
CPT code 86413 for SARS-CoV-2 (COVID-19) quantitative antibody testing is effective and must be used for dates of service as of September 08, 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
Revenue code 0551 may be used by Home Health Agencies performing specimen collection for SARS-CoV-2 (COVID-19) and related respiratory pathogens' laboratory testing:
- 0551: Skilled Nursing – Visit Charge
LABORATORY TESTING FOR COVID-19 DIFFERENTIAL DIAGNOSIS
SPECIMEN COLLECTION FOR COVID-19 DIFFERENTIAL DIAGNOSIS LABORATORY TESTING