Read the Emergency Use Authorization for LUCIRA® by Pfizer COVID-19 & Flu Test
FAQs
Frequently asked questions
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What can a molecular test detect?
Does LUCIRA® by Pfizer COVID-19 & Flu Test monitor for new SARS-CoV-2 variants and flu strains?
How many times can I use the test?
What is the shelf life of the test?
What if there is an invalid result for any of the viruses?
Is LUCIRA® by Pfizer COVID-19 & Flu Test covered by insurance?
LUCIRA® by Pfizer COVID-19 & Flu Test is reimbursable. As a molecular, multiplex respiratory diagnostic test, LUCIRA® by Pfizer falls under CPT code 87636, as defined by the American Medical Association:
87636: Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]) and influenza virus types A and B, multiplex amplified probe technique.4,6-9
QW modifier must be used when billing for tests performed in facilities with a CLIA certificate of waiver.
The QW modifier must be added to 87636 to denote that the LUCIRA® by Pfizer COVID-19 & Flu Test diagnostic test is being conducted in your office setting and not in a traditional lab setting. Please ensure that when billing for LUCIRA® by Pfizer COVID-19 & Flu Test, the code 87636QW is used.
Have questions about LUCIRA® by Pfizer COVID-19 & Flu Test?
CLIA, Clinical Laboratory Improvement Amendments of 1988.
*The LUCIRA® by Pfizer COVID-19 & Flu Test provides a level of accuracy comparable to highly sensitive lab-based polymerase chain reaction (PCR) tests. Negative results do not preclude SARS-CoV-2, influenza A, and/or influenza B infection and should not be used as the sole basis for patient management decisions.4
References: 1. COVID-19 test basics. US Food and Drug Administration. Accessed April 16, 2024. https://www.fda.gov/consumers/consumer-updates/covid-19-test-basics#:~:text=Molecular 2. Hayden MK, Hanson KE, Englund JA, et al. The Infectious Diseases Society of America guidelines on the diagnosis of COVID-19: antigen testing. Clin Infect Dis. Published online January 26, 2023. doi:10.1093/cid/ciad032 3. LUCIRA® by Pfizer COVID-19 & Flu Test. Package Insert. Pfizer Inc; 2023. 4. LUCIRA® by Pfizer COVID-19 & Flu Test. Instructions for Use. Pfizer Inc; 2023. 5. LUCIRA® by Pfizer COVID-19 & Flu Test letter of authorization. US Food and Drug Administration. Published June 15, 2023. Accessed September 14, 2023. https://www.fda.gov/media/163455/download 6. New CPT codes for multi-virus tests detect COVID-19 and flu. American Medical Association. Published October 7, 2020. Accessed February 28, 2024. https://www.ama-assn.org/press-center/press-releases/new-cpt-codes-multi-virus-tests-detect-covid-19-and-flu 7. Diagnostic laboratory tests. Medicare.gov. Accessed October 9, 2023. https://www.medicare.gov/coverage/diagnostic-laboratory-tests 8. Reimbursement policy: diagnostic testing of influenza - lab benefit program. EmblemHealth ConnectiCare. https://www.emblemhealth.com/content/dam/global/pdfs/provider/reimbursement-policies/influenza.pdf 9. Coronavirus (COVID-19) coverage and benefits. EmblemHealth. https://www.emblemhealth.com/covid19