CurrentsimplyhealthcarePolicy N/A

COVID-19 laboratory testing guidance — coverage criteria

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Guidance on Medicaid and Florida Healthy Kids coverage for COVID-19 laboratory tests provided by Simply Healthcare Plans, Inc. and Clear Health Alliance; describes which test types and codes are covered and ordering and lab requirements for reimbursement.

Policy Summary

Payersimplyhealthcare

PolicyCOVID-19 laboratory testing guidance — coverage criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionOrder antibody tests only if FDA-authorized and ensure they are ordered by a Florida licensed physician and performed in a CLIA-certified laboratory.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

U0001,U0002,87635,86769procedure codes listed as covered for COVID-19 testing

U0001-U0004/87635 not for antibodiesantibody testing coding restriction

FDA-authorizedFDA authorization required

Florida MD orderOrdering requirement

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CurrentsimplyhealthcarePolicy N/A

COVID-19 laboratory testing guidance — coverage criteria

Customize your policy alerts

Sign up for all simplyhealthcare policy alerts

Know when simplyhealthcare releases new policies or updates existing guidance.

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Policy Summary

Payersimplyhealthcare

PolicyCOVID-19 laboratory testing guidance — coverage criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionOrder antibody tests only if FDA-authorized and ensure they are ordered by a Florida licensed physician and performed in a CLIA-certified laboratory.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

U0001,U0002,87635,86769procedure codes listed as covered for COVID-19 testing

U0001-U0004/87635 not for antibodiesantibody testing coding restriction

FDA-authorizedFDA authorization required

Florida MD orderOrdering requirement

COVID-19 Testing Coverage Criteria

Antibody testing — reimbursement conditions

Covered when ALL of the following are met

Antibody testing reimbursement conditions: (1) The antibody test is authorized by the Food and Drug Administration (including Emergency Use Authorization, EUA); (2) The test is ordered by a Florida licensed physician; (3) The test is performed by a laboratory that has CLIA certification or a certificate of waiver.

These conditions apply specifically to antibody (serological) tests as stated in the document.

General COVID-19 testing coverage

Covered

General COVID-19 testing coverage: Simply will cover all medically necessary services required to facilitate testing and treatment of COVID-19, including testing consistent with national guidelines and the specific test categories and procedure codes listed (e.g. U0001, U0002, 87635, 86769) effective on the dates provided.

Applies broadly to the listed test categories and codes.

Providers may NOT bill codes U0001–U0004 or 87635 for serological (antibody) testing. This restriction is explicit: these molecular/diagnostic codes are not acceptable for antibody testing and will not meet the coverage criteria for serological tests.

Covered Codes and Effective Dates

CDC testingCPTCovered

U0001

CDC testing — Real-Time RT-PCR diagnostic panel

Non-CDC testingCPTCovered

U0002

Non-CDC testing — Any technique

Rapid testingCPTCovered

87635

Rapid testing — Infectious agent detection by nucleic acid (DNA or RNA)

Antibody testingCPTCovered

86769

Antibody testing

Effective dates

U0001 (CDC testing)Effective 02/04/2020

U0002 (Non-CDC testing)Effective 02/04/2020

87635 (Rapid nucleic acid detection)Effective 03/13/2020

86769 (Antibody testing)Effective 04/10/2020

Medically Necessary Indications

Medically necessary testing to facilitate testing and treatment of COVID-19 consistent with national guidelines.

Covered when consistent with national guidelines

Medically necessary testing to facilitate testing and treatment of COVID-19 consistent with national guidelines.: Testing is covered when it is medically necessary to facilitate testing and treatment of COVID-19 and is performed in accordance with national guidance; covered test categories include CDC Real‑Time RT‑PCR (U0001), non‑CDC molecular testing (U0002), rapid nucleic acid detection (87635), and antibody (serological) testing (86769) with their respective effective dates.

Laboratory, ordering, and authorization requirements for specific test types (e.g., antibody tests) are detailed elsewhere in the policy.

Provider Requirements and Billing Actions

Prior Authorization

Prior authorization not required in this guidance

The policy does not require prior authorization for COVID-19 testing; it lists covered test codes (U0001, U0002, 87635, 86769) and effective dates but includes no statement that prior authorization is required.

Covered procedure codes listed: U0001, U0002, 87635, 86769
Effective dates provided in the coverage table (see coding section)

Billing Rule

Billing rule: Use antibody-specific code (86769) — do not use U0001-U0004 or 87635

Do not bill using CDC molecular codes or rapid nucleic acid codes for antibody testing; antibody testing must be billed with the antibody-specific code (86769) and only when reimbursement conditions are met.

Ordering and Laboratory Requirements

Step Therapy

Ordering requirement — Florida licensed physician

Antibody (serological) tests must be ordered by a Florida licensed physician in order to meet coverage conditions for reimbursement.

Ensure the ordering practitioner holds a Florida medical license documented on the order.

Non-Covered Uses

Not covered: use of U0001–U0004 or 87635 to report antibody (serological) testing is not allowed and will be denied for reimbursement.

Key Definitions

Serological (antibody) test — definition and intended use

TermSerological (antibody) test

DefinitionSerological tests for COVID-19 detect antibodies against the SARS-CoV-2 virus and are intended for use in the diagnosis of current or past COVID-19 infection, but should not be used as the sole basis for diagnosis.

Intended useAid in diagnosis of current or past infection; supportive evidence only (per FDA guidance).

Related guidanceSee FDA guidance referenced in provider bulletin for limitations on using serological tests as sole diagnostic basis.

Background and Clinical Context

Serological (antibody) tests detect antibodies to SARS‑CoV‑2 and can indicate current or past infection, but antibody tests have specific reimbursement requirements. To be reimbursed for antibody testing the test must be authorized by the FDA (including EUA), must be ordered by a Florida licensed physician, and must be performed by a laboratory with CLIA certification or a certificate of waiver. Additionally, providers must not use molecular testing codes U0001–U0004 or 87635 when reporting antibody testing.