COVID-19 Laboratory Testing Guidance - New Procedure Codes
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Guidance for Simply Healthcare Plans' Medicaid and Florida Healthy Kids coverage of COVID-19 laboratory testing procedure codes, including newly listed codes and coverage requirements for testing and antibody tests.
New procedure codes for COVID-19 laboratory testing (molecular, antigen, and antibody tests) are listed and categorized by test type and detection method.
Antibody tests must be FDA-authorized (including EUA) and performed by CLIA-certified or waived laboratories to be reimbursed.
Coverage Criteria for COVID-19 Testing
Coverage criteria for COVID-19 laboratory testing
Simply will cover medically necessary services required to facilitate testing and treatment of COVID-19. Specific coverage and reimbursement criteria include:
ALL of the following
ALL of the following
- Use procedure codes listed in the provider bulletin for the corresponding test type and detection method.
ALL of the following
- Antibody tests will be reimbursed only if they are authorized by the U.S. Food and Drug Administration (including Emergency Use Authorization) at the time of service.
ALL of the following
- Antibody tests must be performed by a laboratory that has CLIA certification or a certificate of waiver to be reimbursed.
ALL of the following
- Providers may NOT use codes U0001–U0004 or 87635 for antibody testing.
ALL of the following
- Per FDA guidance, serological (antibody) tests detect antibodies to SARS-CoV-2 and are intended for use in diagnosing current or past infection but should not be used as the sole basis for diagnosis of COVID-19.
ALL of the following
- This guidance and listed codes apply to Simply Healthcare Plans, Inc. Medicaid, Clear Health Alliance (Simply) Medicaid, and Florida Healthy Kids for Simply Healthcare Plans, Inc.; per-code effective dates are provided in the provider bulletin table and should be consulted by providers.
Informational
- Providers must check FDA EUA status as the FDA may add or revoke EUAs; ensure each antibody test has EUA approval prior to rendering to a Medicaid recipient.
- Consult the provider bulletin table for new and previously covered COVID-19 laboratory testing procedure codes categorized by test type and detection method.
ALL of the following
- Providers must use the appropriate procedure code from the bulletin corresponding to the test performed; antibody testing reimbursement is subject to FDA authorization and CLIA/certificate of waiver requirements; providers cannot bill antibody testing using U0001–U0004 or 87635.
COVID-19 Laboratory Testing Codes and Requirements
| U0001 | CDC 2019 novel coronavirus real-time RT-PCR diagnostic panel |
| U0002 | 2019-nCoV/2019 novel coronavirus non-CDC laboratory tests |
| U0003 | 2019-nCoV specimen testing for high throughput |
| U0004 | 2019-nCoV non-CDC high throughput testing |
| 87635 | Infectious agent detection by nucleic acid (DNA or RNA) |
| 87636 | COVID-19 and influenza A and B multiplex amplified probe |
| 87637 | COVID-19, influenza A and B, and RSV multiplex amplified probe |
| 87426 | Infectious agent antigen detection by immunoassay technique (SARS-CoV-2) |
| 87428 | SARS-CoV-2 and influenza A/B antigen detection |
| 87811 | Infectious agent antigen detection by immunoassay with direct optical observation (antibody test) |
Provider Billing and Reimbursement Actions
Provider billing and reimbursement actions for COVID-19 tests
Use only the procedure codes listed in the provider bulletin for the corresponding COVID-19 test type when submitting claims. Antibody testing will be reimbursed only if the test is FDA-authorized (including EUA) at the time of service and performed by a CLIA‑certified laboratory or one with a certificate of waiver. Do not bill antibody testing using codes U0001–U0004 or 87635.
- Bill molecular, antigen, and antibody tests with the exact CPT/HCPCS codes provided in the bulletin.
- Verify the antibody test is FDA-authorized (including EUA) at time of service; consult FDA EUA listings because authorizations can be revoked or added.
- Ensure the laboratory performing antibody tests holds CLIA certification or a certificate of waiver before billing for reimbursement.
- Do not use codes U0001–U0004 or 87635 for antibody testing claims.
Definitions
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