Humana Severe Acute Respiratory Syndrome Coronavirus 2 Viral Testing Form

Description

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) is the virus that leads to COVID-19 infection. Testing is available that can assess for current or past infection. The US Food & Drug Administration (FDA) has granted emergency use authorization (EUA) for the following 2 types of viral diagnostic testing that can be utilized to determine if there is a current infection:

• Antigen testing – Immunoassay that is performed on a nasal or nasopharyngeal swab specimen. The current FDA-authorized antigen tests include laboratory-based, point-of-care and self-tests (Refer to Coverage Limitations section) and are applicable to an individual of any age. Most antigen tests return results in 15 to 30 minutes. Antigen testing is generally less sensitive than nucleic acid amplification tests (NAATs) in detecting the presence of viral nucleic acid. It may be necessary to confirm an antigen test result with a laboratory based NAAT, especially if the result of the antigen test is inconsistent with the clinical presentation.
• Breathalyzer testing – Rapid gas chromatography-mass spectrometry (GC-MS) is a technique that has been purported to detect volatile organic compounds (VOCs) associated with SARS-CoV-2 infection from an individual’s breath which can provide results within a few minutes. Positive test results from a breath test should be interpreted as presumptive and be confirmed by NAAT.6 (Refer to Coverage Limitations section)
• Genotype testing – Next-generation sequencing (NGS) for the identification and differentiation of SARS-CoV-2 Phylogenetic Assignment of Named Global Outbreak (PANGO) lineages and/or for the identification of specific SARS-CoV-2 variants. These tests are not intended to be utilized in making a primary SARS-CoV-2 infection diagnosis, confirming the presence of infection or identifying specific SARS-CoV-2 genomic variants. (Refer to Coverage Limitations section)
• Molecular, also known as nucleic acid amplification testing (NAAT) – Specimen is collected from either the upper or lower respiratory tract and testing identifies the ribonucleic acid (RNA) sequences that comprise the genetic material of the virus. Reverse transcription polymerase chain reaction (RT-PCR) is one of the most common methods NAATs utilize to amplify nucleic acids and detect the virus. The current FDA-authorized NAATs include laboratory-based, point-of-care and self-tests (Refer to Coverage Limitations section) and are applicable to an individual of any age. The gold standard for clinical diagnostic detection of SARS-CoV-2 is laboratory based (moderate- and high-complexity) NAATs. Some NAATs are considered rapid tests that are performed at or near the place where the specimen is collected and can provide the result within minutes, whereas the time to complete laboratory based NAATs ranges from less than an hour to greater than a day.

A serologic test (also known as an antibody test) may be utilized to determine a past COVID-19 infection. Antibody tests should not be used to diagnose a current infection.

For information regarding serologic (antibody) testing for SARS-CoV-2, please refer to Severe Acute Respiratory Syndrome Coronavirus 2 Serologic (Antibody) Testing Medical Coverage Policy.

A Tiger Tech COVID Plus Monitor consists of an armband with embedded optical sensors and a processor.

During use, the armband is wrapped around the individual’s left arm above the elbow. The sensors acquire biosignals from the outer bicep over a period of 3 to 5 minutes. The processor first extracts a series of biomarkers from the pulsatile signals, which have been correlated with biomarkers of certain conditions, such as hypercoagulation that may be associated with SARS-CoV-2 infection. The processor then predicts whether the recipient is showing certain signals, such as hypercoagulation in blood. The prediction requires roughly two minutes of motionless data. It is not intended to diagnose or exclude SARS-CoV-2 infection. (Refer to Coverage Limitations section)

For information regarding multiplex pathogen testing panels, please refer to Multiplex Pathogen Testing and Next-Generation Sequencing for Infectious Disease Medical Coverage Policy.

Coverage Determination

Any federal or state mandates for SARS-CoV-2 viral testing take precedence over this medical coverage policy.

Laboratory Based Testing

Humana members may be eligible under the Plan for laboratory based SARS-CoV-2 viral (antigen or molecular) testing when the following criteria are met:

• Ordered by a physician or other licensed healthcare professional; AND
• Test has received FDA approval or EUA (Antigen Diagnostic Tests [eg, 0408U]; Molecular Diagnostic Tests)

AND any of the following:

1. Individual has symptoms of COVID-19 (eg, cough, difficulty breathing, fatigue, fever, headache, nasal congestion, new loss of sense of taste or smell, sore throat)
2. Individual is asymptomatic with a known exposure to another individual with suspected or confirmed COVID-19 and has not tested positive within the past 3 months

Coverage Limitations

Humana members may NOT be eligible under the Plan for SARS-CoV-2 viral testing for any indications other than those listed above including, but may not be limited to, the following:

• Employment (eg, pre-employment, return to work) or school purposes (eg, return to school); OR
• Entertainment purposes (eg, prior to a concert or sporting event); OR
• General population or public health screening; OR
• Over-the counter (OTC) testing (generally excluded by certificate) (eg, K1034, K1035); OR
• Physicals (executive or routine); OR
• Screening in a congregate setting; OR
• Sports participation; OR
• Travel purposes

This is considered not medically necessary as defined in the member’s individual certificate.

Please refer to the member’s individual certificate for the specific definition.

Humana members may NOT be eligible under the Plan for the following SARS-CoV-2 viral testing methods for any indications including, but may not be limited to:

• Breathalyzer testing; OR
• Genotype testing (eg, 87913); OR
• Tiger Tech COVID Plus monitoring

These are considered experimental/investigational as it is not identified as widely used and generally accepted for any other proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language.

Additional Information about SARS-CoV-2

Additional information about SARS-CoV-2 may be found from the following websites:

• Centers for Disease Control and Prevention
• National Library of Medicine
• US Food & Drug Administration

Medical Alternatives

Physician consultation is advised to make an informed decision based on an individual’s health needs.

Humana may offer a disease management program for this condition. The member may call the number on his/her identification card to ask about our programs to help manage his/her care.

Any CPT, HCPCS or ICD codes listed on this medical coverage policy are for informational purposes only. Do not rely on the accuracy and inclusion of specific codes. Inclusion of a code does not guarantee coverage and or reimbursement for a service or procedure.