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    v1.0.28
    OpenPayerPolicy UpdatesInfectious DiseaseHealthfirst HIV testing Coverage Update | OpenPaye…
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    ModifiedHealthfirstPolicy PO-RE-019v6

    Human Immunodeficiency Virus (HIV) testing and resistance evaluation

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    Defines coverage criteria for HIV screening, confirmatory testing, nucleic acid testing, viral load monitoring, and genotypic/phenotypic resistance testing for members, including indications, limitations, and testing frequency considerations.

    Policy Summary
    PayerHealthfirst
    PolicyHuman Immunodeficiency Virus (HIV) testing and resistance evaluation
    Policy CodePolicy PO-RE-019v6
    Change TypeMaterial revisions (coverage criteria and testing intervals)
    Effective DateFeb 1, 2026
    Last ReviewDec 15, 2025
    Next Review DateN/A
    Key ActionFor repeat testing, document prior antibody/antigen and nucleic acid test dates and adhere to minimum intervals (antibody/antigen ≥90 days; NAAT ≥1 month).
    SourceLink
    POLICY UPDATE CHANGES

    New coverage criteria CC3, CC4, and CC9 were added clarifying coverage for PrEP-related screening, HIV-1/HIV-2 differentiation assay after a positive screen, and that standalone antigen testing does not meet coverage.

    Frequency limits for antibody/antigen and nucleic acid testing were added and moved into Note 1: antibody/antigen testing no more often than every 90 days; NAAT no more often than once per month.

    CC1 and CC2 updated to include antigen/antibody combination assay for initial and repeat screening for ages 11 to 65.

    11-65age range for routine screening
    90 daysmin interval: antibody/antigen
    1 monthmin interval: NAAT
    200 cp/mLvirological-failure ref
    ≥1000 cp/mLcesarean threshold
    CC3, CC4, CC9new criteria added

    Coverage Criteria for HIV Testing and Resistance Evaluation

    Covered Indications

    Covered when the specific indications below are met

    Screening (initial): 1. For individuals 11 to 65 years of age, initial screening for HIV infection with an antigen/antibody combination assay MEETS COVERAGE CRITERIA.age 11-65

    See Note 1 for frequency limits

    Screening (repeat): 2. For individuals 11 to 65 years of age, repeat antigen/antibody screening for HIV infection MEETS COVERAGE CRITERIA.repeat interval per Note 1

    See Note 1 for testing intervals

    PrEP or elevated risk screening: 3. For individuals who will begin pre‑exposure prophylaxis (PrEP), for individuals receiving PrEP, or for individuals with elevated risk factors for an HIV infection, screening with an antigen/antibody combination assay or with a rapid antibody test MEETS COVERAGE CRITERIA.
    Policy Summary
    PayerHealthfirst
    PolicyHuman Immunodeficiency Virus (HIV) testing and resistance evaluation
    Policy CodePolicy PO-RE-019v6
    Change TypeMaterial revisions (coverage criteria and testing intervals)
    Effective DateFeb 1, 2026
    Last ReviewDec 15, 2025
    Next Review DateN/A
    Key ActionFor repeat testing, document prior antibody/antigen and nucleic acid test dates and adhere to minimum intervals (antibody/antigen ≥90 days; NAAT ≥1 month).
    SourceLink
    On This Page
    Coverage Criteria for HIV Testing and Resistance EvaluationApplicable Codes and Testing IntervalsProvider Guidance, Documentation, and Billing ActionsDefinitions and Test TypesClinical BackgroundPolicy Revision History
    per Note 2 risk factors

    See Note 2 for list of risk factors

    Confirmatory testing: 4. For individuals for whom initial screening was positive for an HIV infection, the HIV‑1/HIV‑2 antibody differentiation assay MEETS COVERAGE CRITERIA.positive initial screening

    See Note 1 for timing

    Nucleic acid testing (diagnostic/confirmatory): 5. Nucleic acid testing (qualitative or quantitative) for HIV‑1 and HIV‑2 MEETS COVERAGE CRITERIA for: a) individuals with a positive initial screening; b) individuals with an indeterminate initial screening; and c) individuals with suspected or recent exposure.see Note 1 for repeat interval

    See Note 1 and Note 2

    Genotype/Phenotype testing indications: 6. HIV genotyping or phenotyping MEETS COVERAGE CRITERIA for listed clinical situations, including prior to initiating doravirine (required), failed antiviral therapy, suboptimal viral load reduction, documented noncompliance, to guide decisions in acute/recent infection (within 6 months), for antiretroviral‑naïve individuals entering treatment, and for pregnant individuals before initiation of ART or with detectable HIV RNA.as clinically indicated

    Genotyping and phenotyping required prior to doravirine therapy

    Phenotyping for multidrug resistance: 7. For treatment‑experienced individuals on failing regimens suspected to have multidrug resistance, HIV phenotyping MEETS COVERAGE CRITERIA.failing regimens with suspected multidrug resistance
    Viral load monitoring: 8. Plasma quantification of HIV‑1 RNA or HIV‑2 RNA MEETS COVERAGE CRITERIA for monitoring disease progression, monitoring response to antiretroviral therapy, for infants younger than 18 months born to HIV‑positive mothers, and for predicting maternal‑fetal transmission.use same assay platform for serial measurements per Note 3

    See Note 3 for assay consistency

    Not Covered / Not Medically Necessary

    Not covered tests: 9. HIV antigen testing independent of antigen/antibody testing DOES NOT MEET COVERAGE CRITERIA. 10. Routine combined genotyping and phenotyping DOES NOT MEET COVERAGE CRITERIA. 11. Drug susceptibility phenotype prediction using genotypic comparison to known genotypic/phenotypic databases DOES NOT MEET COVERAGE CRITERIA.

    Medical necessity criteria for HIV RNA testing and resistance testing

    Covered when meeting DHHS recommended clinical scenarios and timing

    Viral load monitoring cadence: Measure plasma viral load before ART initiation and within 4–8 weeks after starting ART; repeat at 4–8 week intervals until below assay detection. For stable, suppressed patients monitor every 3–4 months and may extend to every 6 months if suppressed >1 year with stable adherence and clinical status.timing-based (4–8 weeks; 3–4 months; possible 6 months)

    DHHS/IDSA guidance

    Resistance testing - indications: Genotypic resistance testing is recommended at entry into care to guide initial ART, in acute/recent infection, in pregnant people before ART initiation, and in persons with virologic failure or suboptimal response; include integrase gene testing if INSTI resistance is suspected or prior CAB‑LA/INSTI exposure.viral load and clinical context (see next node for thresholds)

    DHHS guidance; integrase testing may need separate order

    Resistance testing timing: Perform resistance testing while the patient remains on ARV regimen or within 4 weeks after stopping non‑long‑acting agents; for long‑acting agents (e.g., CAB‑LA) perform testing regardless of time since discontinuation.timing-based

    DHHS AII/AIII guidance

    Confirmatory testing for acute/discordant results: When Ag/Ab is reactive and antibody differentiation is negative/indeterminate, obtain quantitative or qualitative HIV RNA and repeat RNA on a new specimen to confirm low‑positive results; in PrEP users with very low RNA (<200 copies/mL), obtain confirmatory antibody and repeat RNA before initiating ART unless RNA ≥200 copies/mL while on PrEP (then start ART while confirming).viral load‑based (e.g., <200 vs ≥200 copies/mL)

    DHHS recommendations

    Medical necessity criteria

    Covered when clinical and guideline-based indications are met as follows:

    Screening recommendations: Screening for HIV is recommended per USPSTF and CDC guidance, including routine screening of adolescents and adults and universal screening in pregnancy; use FDA‑approved antigen/antibody immunoassays with supplemental differentiation for reactive results.

    Refer to USPSTF/CDC guidance

    Baseline and monitoring viral load: Obtain quantitative HIV RNA at diagnosis/baseline and to monitor ART response; examples: measure within 4–8 weeks of ART start, then every 3 months until suppressed, then every 3–6 months per IDSA/BHIVA guidance.

    See IDSA, BHIVA guidance

    Pregnancy-specific actions: Screen all pregnant women; if viral load >1,000 copies/mL near delivery consider scheduled cesarean delivery at 38 0/7 weeks to reduce mother‑to‑child transmission; measure viral load in third trimester for delivery planning.>1000 copies/mL

    ACOG/SMFM guidance

    Screening, Diagnostic NAAT, Differentiation, and Quantification

    Covered when specified criteria below are met

    CC1: For individuals 11 to 65 years of age, initial screening for HIV infection with an antigen/antibody combination assay MEETS COVERAGE CRITERIA.

    See Note 1 for frequency limits

    CC2: For individuals 11 to 65 years of age, repeat antigen/antibody screening for HIV infection (no more than one test every 90 days) MEETS COVERAGE CRITERIA.No more often than every 90 days

    Note 1

    CC3: Nucleic acid testing (qualitative or quantitative) for HIV‑1 and HIV‑2 (no more than one test every month) MEETS COVERAGE CRITERIA in any of the following situations: a) initial screening positive; b) initial screening indeterminate; c) recent exposure suspected or reported; and for individuals who will begin or are receiving PrEP or have elevated risk factors.No more often than once per month

    See Note 1 and Note 2 for risk factors

    CC4: For individuals for whom initial screening was positive for an HIV infection, the HIV‑1/HIV‑2 antibody differentiation assay MEETS COVERAGE CRITERIA.
    CC6: Plasma quantification of HIV‑1 RNA or HIV‑2 RNA MEETS COVERAGE CRITERIA (no more than one test every month) for specified clinical situations including monitoring disease progression, monitoring response to ART, infants <18 months born to HIV‑positive mothers, and predicting maternal‑fetal transmission.No more often than once per month

    Note 1

    The policy excludes certain tests from coverage because there is insufficient published evidence showing these add clinical benefit. Specifically, HIV antigen testing performed alone (without an antigen/antibody combination assay) does not meet coverage criteria. Additionally, routine concurrent use of genotyping and phenotyping for all patients is not covered, and drug‑susceptibility phenotype prediction derived solely from genotypic comparison to databases is not covered.

    Providers should note that commonly used HIV-1 RNA assays do not detect HIV‑2. HIV‑1 RNA testing is unreliable for HIV‑2 detection and the FDA has not approved HIV‑2 RNA or DNA tests. When HIV‑2 infection is suspected or differentiation is required, use of DNA testing for HIV‑2 or other recommended confirmatory methods is appropriate.

    Routine proviral DNA resistance testing is not required before switching to two‑drug regimens unless there is documented or suspected treatment failure. The policy follows guideline statements that proviral resistance testing is unnecessary for switches when there is no history of treatment failure, and that genotypic testing should be performed when virologic failure is confirmed, preferably while the patient remains on the failing regimen.

    The policy explicitly states that HIV antigen testing performed independently of an antigen/antibody combination assay DOES NOT MEET COVERAGE CRITERIA (CC9). Antigen testing should be performed only as part of an approved antigen/antibody combination screening strategy or per other covered indications.

    Because evidence does not support routine benefit, the policy considers routine combined genotyping and phenotyping and antigen testing alone to be not medically necessary. Genotyping and phenotyping are covered only for specific, documented clinical indications described elsewhere in the policy.

    The policy clarifies that proviral DNA genotyping is not routinely recommended for virologically suppressed persons when used solely to guide regimen switches; results may have uncertain utility in this context. Resistance testing is recommended when virologic failure is present or other specific clinical indications exist.

    Standalone antigen testing (that is, antigen testing performed without an antigen/antibody combination assay) is explicitly listed as not meeting coverage criteria. The policy reiterates that initial screening should use an antigen/antibody combination assay and that antigen‑only assays are excluded from coverage.

    Applicable Codes and Testing Intervals

    Applicable HIV test CPT codesCPT
    86689Antibody; HTLV or HIV antibody, confirmatory test (eg, Western Blot).
    86701Antibody; HIV-1.
    86702Antibody; HIV-2.
    86703Antibody; HIV-1 and HIV-2, single result.
    87389Infectious agent antigen detection by immunoassay technique; HIV-1 antigen(s), with HIV-1 and HIV-2 antibodies, single result.
    87390Infectious agent antigen detection by immunoassay technique; HIV-1.
    87391Infectious agent antigen detection by immunoassay technique; HIV-2.
    87534Infectious agent detection by nucleic acid (DNA or RNA); HIV-1, direct probe technique.
    87535Infectious agent detection by nucleic acid (DNA or RNA); HIV-1, amplified probe technique, includes reverse transcription when performed.
    87536Infectious agent detection by nucleic acid (DNA or RNA); HIV-1, quantification, includes reverse transcription when performed.
    1–10 of 14
    1/2
    Common HIV antibody/antigen and NAAT CPT codesCPTCovered
    86689Antibody; HTLV or HIV antibody, confirmatory test (eg, Western Blot).
    86701Antibody; HIV-1.
    86702Antibody; HIV-2.
    86703Antibody; HIV-1 and HIV-2, single result.
    87389Infectious agent antigen detection by immunoassay technique; HIV-1 antigen(s), with HIV-1 and HIV-2 antibodies, single result.
    87390Infectious agent antigen detection by immunoassay technique; HIV-1.
    87391Infectious agent antigen detection by immunoassay technique; HIV-2.
    87534Infectious agent detection by nucleic acid (DNA or RNA); HIV-1, direct probe technique.
    87535Infectious agent detection by nucleic acid (DNA or RNA); HIV-1, amplified probe technique, includes reverse transcription when performed.
    87536Infectious agent detection by nucleic acid (DNA or RNA); HIV-1, quantification, includes reverse transcription when performed.
    Genotype/phenotype and additional NAAT codesCPTCovered
    87537Infectious agent detection by nucleic acid (DNA or RNA); HIV-2, direct probe technique.
    87538Infectious agent detection by nucleic acid (DNA or RNA); HIV-2, amplified probe technique, includes reverse transcription when performed.
    87539Infectious agent detection by nucleic acid (DNA or RNA); HIV-2, quantification, includes reverse transcription when performed.
    87806Infectious agent antigen detection by immunoassay with direct optical (ie, visual) observation; HIV-1 antigen(s), with HIV-1 and ...
    87900Infectious agent drug susceptibility phenotype prediction using regularly updated genotypic bioinformatics.
    87901Infectious agent genotype analysis by nucleic acid (DNA or RNA); HIV-1, reverse transcriptase and protease regions.
    87903Infectious agent phenotype analysis by nucleic acid with drug resistance tissue culture analysis, HIV-1; first through 10 drugs tested.
    87904Each additional drug tested (List separately in addition to code for primary procedure).
    87906Infectious agent genotype analysis by nucleic acid; HIV-1, other region (eg, integrase, fusion).
    Proprietary/PLA codeCPTCovered
    0219UTargeted viral next-generation sequence analysis (protease, RT, integrase), algorithm reported as prediction of antiviral drug susceptibility (Proprietary: Sentosa® SQ HIV-1 Genotyping Assay).
    HCPCS/G codes and other screening codesHCPCSCovered
    G0432Infectious agent antibody detection by enzyme immunoassay (EIA) technique, HIV-1 and/or HIV-2, screening.
    G0433Infectious agent antibody detection by enzyme-linked immunosorbent assay (ELISA) technique, HIV-1 and/or HIV-2, screening.
    G0435Infectious agent antibody detection by rapid antibody test, HIV-1 and/or HIV-2, screening.
    G0475HIV antigen/antibody, combination assay, screening.
    S3645HIV-1 antibody testing of oral mucosal transudate.
    Relevant viral load thresholds
    Limit of quantitation50 copies/mL
    Assay agreement / virological failure reference200 copies/mL
    Minimal biologically relevant change0.5 log10 change (threefold)
    Typical increase transient return timeframeTransient rises usually return to baseline within one month
    Resistance testing HIV RNA threshold
    Standard genotypic testing threshold (general guidance)>500 to 1,000 copies/mL
    Consider testing at lower levels>200 copies/mL may be considered though testing may be unsuccessful
    Pregnancy-specific notePerform resistance testing in pregnant people with HIV RNA >500 to 1,000 copies/mL; consider even if >500 but <1,000 copies/mL (may be unsuccessful)
    Resistance/clinical action thresholds
    Pregnancy — delivery planningViral load ≥1000 copies/mL at or near delivery → consider scheduled prelabor cesarean at 38 0/7 weeks
    BHIVA HIV-2 resistance testingPerform resistance testing for HIV-2 if viral load ≥500 copies/mL
    EACS availability thresholdGenotypic testing routinely available for HIV‑VL >200–500 copies/mL (specialized labs may test lower)
    Phenotypic testing indicationPhenotypic testing indicated for treatment‑experienced persons on failing regimens with suspected multidrug resistance
    Repeat antibody/antigen testing interval
    Minimum repeat intervalNo more often than once every 90 days
    PurposeApplies to repeat antibody/antigen (Ag/Ab) testing per Note 1
    Documentation expectationDocument dates of prior Ag/Ab tests to demonstrate adherence to the 90‑day interval
    Repeat nucleic acid testing (NAAT) interval
    Minimum repeat intervalNo more often than once every month
    Applies toNucleic acid testing (qualitative or quantitative) including plasma HIV-1/HIV-2 RNA quantification
    Documentation expectationDocument dates of prior NAATs to demonstrate adherence to the monthly interval

    Provider Guidance, Documentation, and Billing Actions

    Prior Authorization

    Molecular HIV Test Coding — Check Prior Authorization

    Prior Authorization: Certain molecular HIV tests and resistance assays may require prior authorization (PA) from Healthfirst. Providers should verify PA requirements with the payer prior to ordering molecular assays (NAAT/RT‑PCR) and resistance testing to avoid claim denials or delays.

    • Verify prior authorization requirements with Healthfirst before ordering molecular HIV tests (e.g., quantitative/qualitative NAAT, RT‑PCR) or specialized resistance assays.
    • If unsure, contact Healthfirst provider services or use the payer portal to confirm PA rules and submission steps.
    Billing Rule

    Referenced Procedure Codes

    Use the applicable procedure codes when ordering and billing HIV diagnostic and resistance assays. Reference the codes below when submitting prior authorization requests and claims to ensure accurate adjudication.

    • Include the specific CPT/HCPCS code on the PA request and on the claim (see code list).
    • If multiple assays are performed, list each test with the appropriate code and specimen date to support medical necessity.
    Documentation Required

    Confirmation Before Initiating ART

    Do not initiate antiretroviral therapy (ART) solely on a single reactive Ag/Ab or RNA result from the original specimen without confirmation from a new specimen unless guidelines explicitly permit immediate treatment (e.g., select PrEP-to-treatment transitions). Collect a new specimen for confirmatory testing prior to ART initiation when diagnostic results are inconclusive.

    • Collect and document a new blood specimen to verify HIV diagnosis before initiating ART when initial Ag/Ab or RNA results are positive but not yet confirmed.
    • Exceptions: follow current DHHS guidance for specific scenarios (e.g., persons with HIV RNA ≥200 copies/mL on PrEP where immediate ART may be started while awaiting confirmation).
    Billing Rule

    Code Adherence and Claim Submission Requirements

    Claims for HIV antibody, antigen, and nucleic acid tests must include the correct CPT/HCPCS codes, appropriate modifiers when required, and supporting documentation (laboratory report, specimen dates, and clinical indication). Missing or incorrect coding may result in denials or recoupment.

    • Submit the specific CPT/HCPCS code that corresponds to the performed assay (see 'Applicable Codes' section).
    • Use modifiers according to NCCI and payer guidance when bundling or when multiple procedures are performed on the same date.
    • Attach laboratory reports and specimen collection dates to substantiate the claim and medical necessity.
    Documentation Required

    Document Confirmatory Testing

    Document confirmatory testing promptly when an initial Ag/Ab assay is reactive. Documentation should show follow‑up with an HIV‑1/HIV‑2 antibody differentiation assay and, if differentiation is negative or indeterminate (or acute infection is suspected), quantitative or qualitative HIV RNA testing. If RNA is undetectable in this context, document that the initial result was likely a false positive.

    • Record the date and result of the initial Ag/Ab assay, the type and date of the differentiation assay (e.g., Geenius), and any subsequent HIV RNA test results.
    • If confirmatory testing was not performed, document the clinical rationale and any barriers to obtaining a new specimen.
    Documentation Required

    Assay Type, Indication, and Supplemental Test Documentation

    When ordering or documenting HIV testing, specify the assay type, the indication for testing, and any supplemental tests performed or planned. This documentation supports medical necessity for coverage of repeat or specialized assays.

    • Specify assay type (e.g., 4th‑generation Ag/Ab immunoassay, Geenius differentiation assay, NAAT/RT‑PCR quantitative viral load, genotypic resistance assay, phenotypic resistance assay).
    • State the clinical indication (e.g., initial screening, symptomatic/acute exposure, monitoring ART response, suspected treatment failure, pregnancy, PrEP evaluation).
    • Document supplemental testing performed when indicated (e.g., differentiation assay after reactive Ag/Ab; RNA testing if differentiation is indeterminate or acute infection suspected).
    • For resistance testing, document whether integrase sequencing was ordered in addition to reverse transcriptase/protease regions when clinically indicated (e.g., prior CAB‑LA exposure or suspected INSTI resistance).
    Billing Rule

    Coding and Billing Documentation Expectations

    Providers must follow applicable coding, billing, and reimbursement guidelines (CPT, HCPCS, ICD‑10, NCCI, NCD/LCD, and appropriate modifier usage). Failure to adhere to these standards can lead to claim denials or recoupment. Maintain and submit clinical documentation to support medical necessity and to respond to potential audit requests.

    • Follow national and state payer coding rules, including NCCI edits and any Healthfirst‑specific edits.
    • Retain and provide clinical records (laboratory results, dates, clinician notes) to support the billed services.
    • Ensure claims are consistent with the patient's evidence of coverage and applicable state/federal mandates.
    Note

    Unspecified Provider Actions / Case‑by‑Case Guidance

    Provider Actions: Not otherwise specified in this section. If additional payer‑specific or benefit‑specific instructions apply, providers should consult Healthfirst policy resources or contact provider services for clarification.

    • If a scenario is not clearly addressed here, obtain prior authorization or written confirmation from Healthfirst before proceeding with non‑routine testing.
    • Use the payer portal or call Healthfirst provider services for case‑specific guidance.

    Definitions and Test Types

    Antigen/antibody combination assay
    DefinitionA screening immunoassay that detects HIV‑1 p24 antigen and antibodies to HIV‑1/HIV‑2 used for initial and repeat screening
    RoleRecommended as the initial laboratory HIV testing method to enhance early (acute) infection detection
    Follow-upReactive Ag/Ab assays require supplemental HIV‑1/HIV‑2 antibody differentiation testing and possible RNA testing if differentiation is negative/indeterminate
    Viral load (plasma HIV RNA) testing
    DefinitionQualitative or quantitative NAAT (RT‑PCR) assays that detect and/or quantify HIV‑1 RNA in plasma used diagnostically in select scenarios and for monitoring ART response
    Platforms / approvalsFDA‑approved platforms include COBAS, RealTime/Alinity m, and Aptima (Aptima approved for diagnostic and quantitation in 2020)
    LimitationsQuantitative assays are routinely used for monitoring; some quantitative tests are not FDA‑approved for diagnosis; HIV‑1 RNA tests do not detect HIV‑2
    Genotypic testing
    DefinitionAssays that detect specific drug‑resistance mutations in HIV genes (protease, reverse transcriptase, integrase) to infer resistance and guide therapy
    Use casesRecommended at diagnosis, prior to treatment initiation, and at virologic failure; integrase testing recommended when INSTI resistance suspected
    LimitationsLess sensitive for low‑level minority variants and may require interpretation via genotypic interpretation systems or databases
    Phenotypic testing
    DefinitionAssays that measure drug inhibition of viral replication (phenotypic), often reporting fold‑change in susceptibility
    IndicationUseful for complex or multidrug resistance patterns in treatment‑experienced failing patients
    LimitationsLonger turnaround time, higher cost, and biologic cut‑offs above achievable drug levels; limited sensitivity for minority variants
    Nucleic acid test (NAT)
    DefinitionA test that detects viral RNA (NAT/NAAT) and can detect infection earlier than antigen/antibody tests; used for acute infection diagnosis and viral load quantification
    Window periodTypical detection range: ~10–33 days after exposure (NAT)
    Diagnostic roleQualitative NAAT is FDA‑approved for diagnosis of acute infection in antibody‑negative persons; quantitative NAATs commonly used for monitoring
    Ag/Ab assay (fourth-generation)
    DefinitionA fourth‑generation immunoassay that detects HIV‑1/HIV‑2 antibodies plus HIV‑1 p24 antigen for earlier detection of infection
    RecommendationRecommended as the initial laboratory HIV testing method; included in policy for initial and repeat screening ages 11–65
    Follow-upReactive results require supplemental differentiation testing; repeat interval governed by Note 1 (≥90 days)
    Fourth-generation antigen/antibody assay
    DefinitionFourth‑generation antigen/antibody assay detects HIV‑1 and HIV‑2 antibodies plus HIV‑1 p24 antigen and is recommended for screening
    Action after reactive resultReactive assays require supplemental HIV‑1/HIV‑2 antibody differentiation; if differentiation is negative/indeterminate, obtain HIV RNA testing
    Policy inclusionPolicy updated to include antigen/antibody combination assays for initial and repeat screening (CC1 and CC2)
    NAAT / RT-PCR HIV-1 viral load assay
    DefinitionNucleic acid amplification tests (RT‑PCR) for quantifying HIV‑1 RNA used to stage disease and monitor ART response
    FDA‑approved platformsExamples include COBAS AmpliPrep/TaqMan, Aptima (Panther), and Alinity m
    Quantitation range (example)Aptima quantitation range cited: 30–10,000,000 copies/mL
    Definitions
    Definitions sectionSee individual assay definitions above for Ag/Ab, NAAT, genotypic and phenotypic testing
    NotePolicy includes multiple specific definitions drawn from CDC, FDA, and guideline sources
    Empty entryNo additional standalone definition provided in this slot

    Clinical Background

    Human immunodeficiency virus (HIV) is an RNA retrovirus that infects CD4+ immune cells and, if untreated, can progress to acquired immunodeficiency syndrome (AIDS). HIV‑1 is the predominant subtype worldwide; HIV‑2 is less common and has different virologic characteristics and diagnostic considerations. Viral load (plasma HIV RNA) testing is used for diagnosis in select situations and routinely to monitor response to antiretroviral therapy; genotypic and phenotypic resistance assays guide management when resistance or treatment failure is suspected.

    Policy Revision History

    2026-02-01Policy effective dateLatest

    Policy PO-RE-019v6 became effective with updated coverage criteria including CC1-CC4 and CC6, frequency limits for antibody/antigen and NAAT testing, and expanded screening modalities.

    2025-12-15Last review/approval

    Policy last reviewed and approved; background, guidelines, and evidence-based scientific references updated.

    2025-09-04Revision

    Reviewed and updated background, guidelines, and evidence-based scientific references.

    2025-??-??Revision note (documented change logs)

    Notes added clarifying testing intervals: antibody/antigen testing no more often than every 90 days and NAAT no more often than once per month; CC6 updated to include monthly NAAT frequency limits.

    This policy was updated to add new and renumbered coverage criteria and to operationalize frequency limits. Material changes include new coverage items (CC3, CC4, CC9) clarifying PrEP‑related screening and confirmatory differentiation testing, and an explicit statement that antigen‑only testing does not meet coverage criteria. The update also established frequency limits: antibody/antigen testing no more often than every 90 days and nucleic acid testing no more often than once per month.