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    v1.0.30
    OpenPayerPolicy UpdatesLaboratory/PathologyProvidence Respiratory Panels Policy Update | Open…
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    CurrentProvidence Health PlanPolicy 255

    Respiratory Viral Panels

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    This Medicare medical policy governs coverage and medical necessity for molecular syndromic respiratory viral panels and related respiratory pathogen tests billed to Providence Medicare Advantage members. Coverage depends on the applicable CMS regional LCD or Medicare guideline, FDA-cleared or approved use, supporting diagnosis coding, applicable place-of-service requirements, and member benefit provisions.

    Policy Summary
    PayerProvidence Health Plan
    PolicyRespiratory Viral Panels
    Policy CodePolicy 255
    Change TypeCoding update
    Effective DateOct 1, 2026
    Last ReviewSep 1, 2026
    Next Review DateJul 1, 2027
    Key ActionSubmit the applicable ICD-10 diagnosis code or codes supporting medical necessity with the respiratory testing claim.
    SourceLink
    POLICY UPDATE CHANGES

    The October 2026 revision includes Q4 2026 code updates to the respiratory viral panel coding information.

    13States with regional CMS LCD applicability

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    3Regional CMS LCD groupings
    11Group 6 potentially medically necessary codes
    4Group 1 potentially medically necessary codes
    RequiredFDA clearance or approval
    NonePolicy cross references

    Covered Respiratory Testing

    Medical Necessity and Coverage Requirements

    General Respiratory Panel Medical Necessity

    Respiratory panel testing is potentially medically necessary only when all applicable requirements are met.

    General medical necessity requirements

    • The service is a respiratory viral or respiratory pathogen panel addressed by this policy.
    • The applicable Medicare guideline or regional CMS LCD supports the service.
    • The test has FDA clearance or approval and is performed consistently with its intended-use labeling.
    • The claim includes an ICD-10 diagnosis code supporting medical necessity under LCA A58720.

    • Applicable regional CMS coverage reference

      • For testing performed in AK, ID, OR, WA, UT, AZ, MT, ND, SD, WY, CA, HI, or NV, apply LCD L39001.
      • For testing performed in VA, WV, NC, SC, GA, TN, or AL, apply LCD L38988.
      • For testing performed in IL, MN, WI, CT, NY, ME, MA, NH, RI, VT, apply LCD L39027.

    Group 1 Code Criteria

    For Group 1 codes, both requirements must be met.

    Group 1 requirements

    • Bill CPT 87631, 87636, 87637, or 87812.
    • Bill the code with an ICD-10 diagnosis code supporting medical necessity as listed in Group 1 of LCA A58720.

    Group 6 Code Criteria

    For Group 6 codes, both the code-specific diagnosis requirement and the additional Group 6 condition must be met.

    Group 6 requirements

    • Bill CPT 87632, 87633, 0115U, 0202U, 0223U, 0225U, 0528U, 0563U, or 0564U.
    • Bill the code with an ICD-10 diagnosis code supporting medical necessity as listed in Group 6 of LCA A58720.

    • Additional Group 6 condition

      • Use diagnosis codes from two different diagnosis code lists within LCA A58720.
      • Use a place of service that warrants the medical need for the test.

    Services or items that are direct exclusions under Medicare or the member’s Evidence of Coverage are not covered, even when they may appear medically indicated for an individual. Examples include services that are cosmetic, not medical in nature, or not medically reasonable and necessary under section 1862(a)(1)(A) of the Social Security Act.

    Testing without an FDA-cleared or approved indicated use, or FDA-approved testing performed inconsistently with its intended-use labeling, may require MolDX registration and a Technical Assessment. The service may not qualify for Medicare coverage unless the applicable requirements are satisfied.

    The respiratory testing codes addressed by this policy are not potentially medically necessary when billed without an ICD-10 diagnosis code supporting medical necessity under the applicable diagnosis list in LCA A58720. For Group 6 codes, the claim must also include diagnosis codes from two different LCA diagnosis lists or a place of service that warrants the medical need for the test.

    Covered and Applicable Codes

    Group 1 potentially medically necessary codesCPTCovered
    87631Respiratory virus nucleic acid detection, 3-5 targets
    87636SARS-CoV-2 and influenza virus types A and B, multiplex amplified probe technique
    87637SARS-CoV-2, influenza virus types A and B, and respiratory syncytial virus, multiplex amplified probe technique
    87812SARS-CoV-2 and influenza virus types A and B antigen detection by immunoassay with direct optical observation
    Group 6 potentially medically necessary codesCPTCovered
    87632Respiratory virus nucleic acid detection, 6-11 targets
    87633Respiratory virus nucleic acid detection, 12-25 targets
    0115URespiratory infectious agent detection by nucleic acid, 18 viral types and subtypes and 2 bacterial targets, multiplex reverse transcription for RNA targets
    0202UInfectious disease bacterial or viral respiratory tract infection pathogen-specific nucleic acid, 22 targets including SARS-CoV-2, qualitative RT-PCR, nasopharyngeal swab
    0223UInfectious disease bacterial or viral respiratory tract infection pathogen-specific nucleic acid, 22 targets including SARS-CoV-2, qualitative RT-PCR, nasopharyngeal swab
    0225UInfectious disease bacterial or viral respiratory tract infection pathogen-specific DNA and RNA, 21 targets including SARS-CoV-2, amplified probe technique
    0528UInfectious disease bacterial and viral respiratory tract infection pathogen-specific nucleic acid, 21 targets including 11 viral and 4 bacterial targets, qualitative RT-PCR, upper respiratory specimen
    0563UInfectious disease bacterial or viral respiratory tract infection pathogen-specific DNA and RNA, 12 targets, nasopharyngeal or oropharyngeal swab
    0564UInfectious disease bacterial and/or viral respiratory tract infection pathogen-specific nucleic acid, 11 viral targets and 4 bacterial targets, qualitative RT-PCR, upper respiratory specimen
    Proprietary respiratory tests and associated PLA codesCPT
    0115UePlex Respiratory Pathogen Panel
    0202UBioFire FilmArray Respiratory Panel 2.1
    0223UQIAstat-Dx Respiratory SARS-CoV-2 Panel
    0225UePlex Respiratory Pathogen Panel 2
    0528UBIOFIRE FILMARRAY Pneumonia Panel and BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel when selected from the Respiratory Menu
    0564UBIOFIRE SPOTFIRE Respiratory/Sore Throat Panel
    Unlisted code handlingmixed
    Unlisted codesUnlisted codes submitted for services addressed by this policy
    Respiratory Virus Panel Target Counts
    87631Respiratory virus nucleic acid detection, 3-5 targets
    87632Respiratory virus nucleic acid detection, 6-11 targets
    87633Respiratory virus nucleic acid detection, 12-25 targets

    Billing and Documentation Requirements

    Prior Authorization

    Prior Authorization Recommended for Unlisted Codes

    For an unlisted code representing a potentially covered service addressed by this policy, prior authorization is recommended to help avoid a post-service processing delay or denial. All unlisted codes are reviewed at the claim level for medical necessity, correct coding, and pricing.

    Documentation Required

    Submit Supporting Diagnosis and Place of Service

    Submit supporting ICD-10 diagnosis coding for the billed respiratory viral panel. For specified services, also submit the applicable place-of-service information or diagnosis coding required by the applicable local coverage article.

    • CPT 87631, 87636, 87637, and 87812 require an ICD-10 code supporting medical necessity under LCA A58720, Group 1.
    • CPT 87632, 87633, 0115U, 0202U, 0223U, 0225U, 0528U, 0563U, and 0564U require an ICD-10 code supporting medical necessity under LCA A58720, Group 6.
    • Group 6 services require diagnosis codes from two different diagnosis-code lists in the LCA, or a place of service that warrants the medical need for the test.

    Coverage Reference Terms

    Regional CMS LCD
    DefinitionA CMS local coverage determination addressing molecular syndromic panels for infectious disease pathogen identification testing.
    AK, ID, OR, WA, UT, AZ, MT, ND, SD, WY, CA, HI, NVApply LCD L39001: MolDX: Molecular Syndromic Panels for Infectious Disease Pathogen Identification Testing.
    VA, WV, NC, SC, GA, TN, ALApply LCD L38988: MolDX: Molecular Syndromic Panels for Infectious Disease Pathogen Identification Testing.
    IL, MN, WI, CT, NY, ME, MA, NH, RI, VTApply LCD L39027: Respiratory Pathogen Panel Testing.
    ApplicabilityThe policy applies these regional references to respiratory conditions and panels only; CMS guidance governs if it conflicts with the Providence medical policy.
    MolDX Technical Assessment

    Policy Scope and Testing Context

    This policy addresses molecular syndromic respiratory viral panels and related nucleic-acid or antigen detection testing for respiratory pathogens. Coverage is specific to respiratory conditions and depends on the applicable Medicare guideline or regional CMS LCD, FDA-cleared or approved intended use, supporting diagnosis coding, and other applicable Medicare and member benefit requirements.

    Excluded Services

    Tests or services excluded by Medicare or the member’s Evidence of Coverage are not covered. This includes services that are cosmetic, not medical in nature, or not medically reasonable and necessary under section 1862(a)(1)(A) of the Social Security Act.

    Policy Summary
    PayerProvidence Health Plan
    PolicyRespiratory Viral Panels
    Policy CodePolicy 255
    Change TypeCoding update
    Effective DateOct 1, 2026
    Last ReviewSep 1, 2026
    Next Review DateJul 1, 2027
    Key ActionSubmit the applicable ICD-10 diagnosis code or codes supporting medical necessity with the respiratory testing claim.
    SourceLink
    On This Page
    Covered Respiratory TestingMedical Necessity and Coverage RequirementsCovered and Applicable CodesBilling and Documentation RequirementsCoverage Reference TermsPolicy Scope and Testing ContextExcluded Services
    Documentation Required

    Document FDA Clearance, Approval, and Intended Use

    Document that the test has FDA clearance or approval for the billed use and is performed consistently with its FDA intended-use labeling. FDA clearance is a prerequisite for Medicare coverage; services without an FDA-cleared or approved indicated use, or performed inconsistently with intended-use labeling, require MolDX registration and a Technical Assessment to demonstrate compliance with the policy.

    • Maintain documentation identifying the applicable FDA clearance or approval and indicated use.
    • For applicable services, document compliance with the FDA intended-use labeling directions.
    • Refer to the applicable Medicare MolDX LCD and current MolDX requirements.
    Denial Risk

    Unsupported Diagnosis or Place of Service May Result in Denial

    Claims may be denied when the required diagnosis coding does not support medical necessity or when the applicable place-of-service requirements are not met. Use the diagnosis-code lists and POS requirements in the applicable local coverage article when submitting these services.

    • Confirm that the billed service is paired with the required supporting ICD-10 diagnosis code.
    • For Group 6 services, confirm the required diagnosis-code-list combination or qualifying place of service.
    Denial Risk

    Verify Regulatory, Benefit, and Medical-Necessity Requirements

    Coverage is subject to FDA status and intended-use requirements, an applicable Medicare benefit category, statutory requirements, coding and pricing guidelines, applicable national and local coverage determinations, clinical evidence, and member benefit limitations. FDA clearance alone does not establish medical necessity or guarantee payment.

    • Services lacking an FDA-cleared or approved indicated use, or performed inconsistently with intended-use labeling, may require MolDX registration and a Technical Assessment.
    • A service may be denied when it is excluded from the member's benefits, does not meet medical-necessity requirements, or otherwise fails applicable coverage criteria.
    • The code list is not all-inclusive; code inclusion or omission does not imply or guarantee reimbursement or coverage.
    Denial Risk

    Unlisted Code for Non-Covered Service

    If an unlisted code represents a non-covered service addressed by this policy, the claim will be denied as not covered. Unlisted codes remain subject to claim-level review for medical necessity, correct coding, and pricing.

    • Review the Company's current non-covered and prior authorization lists for additional requirements.
    • Payment amounts or the issuance of a CPT or HCPCS code do not by themselves establish Medicare coverage.
    When requiredMolDX registration and a Technical Assessment may be required for services without FDA-cleared or approved indicated uses.
    FDA-approved testsA Technical Assessment may also be required when an FDA-approved test is performed in a way that is inconsistent with its intended-use labeling directions.
    PurposeThe Technical Assessment demonstrates compliance of the service with the applicable Medicare policy.