medical mutual - ohio HIV Testing Coverage Update

Coverage Criteria and Limitations

inv-01: Covered Testing and Indications

Covered when listed clinical conditions are met

HIV screening (ages 11-65): Initial antigen/antibody combination assay is covered for individuals 11-65 years of age; repeat antigen/antibody screening is covered (but not more often than every 90 days).ages 11-65; repeat interval >=90 days

See Note 1 for repetition intervals.

Screening for high-risk / PrEP individuals: For individuals initiating or receiving PrEP, or with elevated risk factors, screening with antigen/antibody combination assay or rapid antibody test meets coverage criteria.per Note 2 risk factors

Risk factors include MSM, partner with HIV, multiple partners, injection drug use, exchange sex, prior/concurrent STI/hepatitis/TB.

Confirmatory/diagnostic after reactive or indeterminate screen: HIV-1/HIV-2 antibody differentiation assay meets coverage for initial positive screening; nucleic acid testing (qualitative or quantitative) meets coverage for positive or indeterminate initial screening or suspected recent exposure.positive or indeterminate screen or recent exposure

NAAT should not be repeated more often than once monthly (Note 1).

Genotyping/phenotyping coverage: HIV genotyping or phenotyping meets coverage for: prior to doravirine therapy (required), failed antiviral therapy, suboptimal viral load reduction, noncompliance, to guide treatment in acute/recent infection (within 6 months), antiretroviral-naïve individuals entering treatment, and for pregnant individuals before initiation of ART or if detectable RNA.situations a-g listed in policy

Phenotyping meets coverage for treatment-experienced individuals on failing regimens when multidrug resistance is suspected.

Viral load (plasma HIV RNA) coverage: Plasma quantification of HIV-1 or HIV-2 RNA meets coverage for monitoring disease progression, monitoring response to therapy, infants <18 months born to HIV-positive mothers, and predicting maternal-fetal transmission.as clinically indicated

Measure on same analytical method when possible due to assay variability (Note 3).

inv-02: Not Covered

Tests explicitly not meeting coverage

Not covered tests: HIV antigen testing alone does not meet coverage criteria; routine combined genotyping and phenotyping does not meet coverage; drug susceptibility phenotype prediction using genotypic comparison to known databases does not meet coverage.N/A

These are excluded due to insufficient published evidence.

inv-03: Coverage criteria for resistance and viral testing

Covered when meeting DHHS-recommended clinical indications

Initial treatment and entry into care: Genotypic drug-resistance testing is recommended at entry into care to guide selection of initial ART (AII). For ARV-naïve persons, test reverse transcriptase and protease; include integrase if transmitted INSTI resistance is suspected or prior CAB-LA PrEP use.

Do not delay ART for results; modify regimen when available.

Virologic failure and suboptimal response: Drug-resistance testing for persons with virologic failure: generally recommended for HIV-RNA >200 copies/mL (AI for >1,000; AIII for 501-1,000; CIII for 201-500). Perform genotypic testing while on ART or within 4 weeks of stopping non-long-acting agents.>200 copies/mL

Consider integrase testing specifically when failing INSTI-based regimens or prior INSTI exposure.

Pregnancy-specific: Genotypic resistance testing should be performed before initiating ART in pregnant people (AIII) and for those entering pregnancy with detectable HIV-RNA while on therapy (AI). ART should be started promptly and modified if resistance results warrant.

inv-04: Resistance testing and viral load monitoring

Recommendations for resistance testing and viral load monitoring

Baseline resistance testing: Genotypic resistance testing is recommended at the time of HIV diagnosis and prior to initiation of therapy in ART-naïve patients.

Genotype preferred; do not delay ART initiation awaiting results per guidelines.

Phenotypic testing indication: Phenotypic resistance testing should be considered (usually in addition to genotypic testing) for patients with known or suspected complex drug resistance mutation patterns, typically after multiple virologic failures.

Phenotype is reserved for complex cases.

Viral load monitoring after ART initiation: Obtain HIV RNA at baseline and then 2-4 weeks after initiating ART (no later than 8 weeks), then every 4-8 weeks until suppression; once suppressed, monitor every 3 months, and after 1 year of stable suppression may extend to every 6 months.

Frequency varies slightly across societies but captures common intervals.

inv-05: Diagnostic testing and screening intervals

Diagnostic testing workflow and window periods

Initial diagnostic test: Use a fourth-generation HIV antigen/antibody assay for initial diagnostic testing; if reactive follow with HIV-1/HIV-2 antibody differentiation assay.

If indeterminate or high suspicion with negative/indeterminate results, obtain an HIV-1 NAT.

Window periods: antibody tests 23-90 days; finger-stick antigen/antibody 18-90 days; venous antigen/antibody 18-45 days; NAT 10-33 days after exposure.

If test is negative post-exposure, repeat after appropriate window period.

Testing frequency for at-risk populations: CDC: routine testing at least once for ages 13-64; individuals with ongoing risk should be screened at least annually; sexually active MSM may benefit from testing every 3-6 months.

For patients on PrEP, repeat Ag/Ab and HIV-1 RNA at least every 3 months.

inv-06: Pregnancy and HIV-2 monitoring

Pregnancy and HIV-2 specific recommendations

Pregnancy — delivery planning: For HIV-positive pregnant women with viral load >1000 copies/mL near delivery (or unknown viral load), offer scheduled prelabor cesarean at 38 0/7 weeks to reduce mother-to-child transmission.viral load >1000 copies/mL

SMFM recommends measuring viral load at 34-36 weeks and scheduling cesarean at 38 weeks if >=1000 at 37-38 weeks.

HIV-2 viral load monitoring: If pre-treatment HIV-2 viral load detectable: measure at 1, 3 and 6 months after starting/changing ART, then every 3-6 months; if undetectable pre-treatment: measure at 1 month and then every 6 months.

Repeat testing and resistance testing if viral load becomes detectable after maximal suppression.

HIV-2 resistance testing threshold: Perform resistance testing in those on ART when HIV-2 viral load has been maximally suppressed and then becomes repeatedly detectable; perform resistance testing at diagnosis/prior to treatment and at virological failure if viral load >=500 copies/mL.

inv-07: New and revised coverage criteria

Coverage criteria added or clarified during the 09/04/2025 review include the following specific conditions:

CC3 - Screening for PrEP and high-risk individuals: For individuals who will begin pre-exposure prophylaxis (PrEP), for individuals receiving PrEP, or for individuals with elevated risk factors for an HIV infection (see Note 2), screening for an HIV infection with an antigen/antibody combination assay or with a rapid antibody test meets coverage criteria.

See Note 2 for list of risk factors.

CC4 - Follow-up differentiation assay: For individuals for whom initial screening was positive for an HIV infection, the HIV-1/HIV-2 antibody differentiation assay meets coverage criteria.

Referenced as Note 1 in the policy for differentiation following positive screen.

CC9 - Antigen-only testing exclusion: HIV antigen testing independent of antigen/antibody testing does not meet coverage criteria.

Ordering antigen testing alone may not be covered.

inv-08: Testing frequency limits

Testing frequency guidance (moved into Note 1):

Frequency limits: Antibody and antibody/antigen testing should not be repeated more often than once every 90 days. Nucleic acid testing (qualitative or quantitative) should not be repeated more often than once every month.Antibody/Ag: >=90 days; NAAT: >=1 month

These frequency rules were consolidated into Note 1.

The policy lists specific testing modalities that do not meet coverage criteria due to insufficient published evidence. Notably, HIV antigen testing performed independent of an antigen/antibody combination assay is excluded. Additionally, the policy states that the routine use of combined genotyping and phenotyping and drug susceptibility phenotype prediction using genotypic comparison to reference databases do not meet coverage and therefore may be denied if billed as covered services.

The revision history reinforces that ordering an antigen test alone is specifically excluded from coverage. The update (09/04/2025) operationalized this exclusion as CC9: HIV antigen testing independent of antigen/antibody testing DOES NOT MEET COVERAGE CRITERIA. Providers should therefore order antigen testing only as part of a covered antigen/antibody algorithm or follow the policy's approved diagnostic pathways.

The European AIDS Clinical Society guidance cited in the policy notes that proviral DNA genotyping may be useful in select situations (e.g., multiple prior virologic failures, unavailable resistance history, or low-level viremia) but cautions that proviral DNA can miss prior resistance mutations or detect clinically irrelevant variants. Consequently, the policy states that routine proviral DNA genotyping is not recommended for virologically suppressed persons who are switching therapy.

The policy explicitly excludes HIV antigen testing performed independent of an antigen/antibody testing algorithm from meeting coverage criteria. This exclusion was restated during the 09/04/2025 revision and is intended to prevent use of standalone antigen assays outside of the recommended screening/diagnostic sequence.

The policy identifies that routine combined genotyping and phenotyping does not meet coverage criteria and that certain predictive phenotype-from-genotype methods (e.g., algorithmic phenotype prediction based solely on genotypic database comparisons) are not covered. The EACS review cited in the policy further clarifies that genotypic testing is generally preferred and that phenotypic testing is reserved for complex, treatment-experienced cases — supporting the policy stance that routine combined testing is not routinely covered.

A cost-effectiveness analysis referenced in the policy modeled point-of-care viral load testing to guide mode of delivery in pregnant women and found that, in that theoretical cohort, point-of-care viral load measurement produced more neonatal infections and higher costs compared with routine cesarean delivery for all. The authors concluded that using point-of-care viral load to guide delivery was less effective and more costly in many scenarios, supporting the policy's cautious position on routine point-of-care viral load use for delivery decision-making.

The policy consolidates testing frequency guidance into Note 1 and restates it as firm limits: antibody or antigen/antibody testing should not be repeated more often than once every 90 days, and nucleic acid testing (qualitative or quantitative) should not be repeated more often than once per month. Tests repeated more frequently than these intervals are outside the routine coverage rules and may be considered not medically necessary unless clearly justified.

Applicable Procedure and Test Codes

Applicable CPT/HCPCS procedure codesmixed

No codes listed

HIV antibody confirmatory and antibody codesCPTCovered

86689	Antibody; HTLV or HIV antibody, confirmatory test (e.g., Western Blot).
86701	Antibody; HIV-1.
86702	Antibody; HIV-2.
86703	Antibody; HIV-1 and HIV-2, single result.

HIV antigen/NAAT/antigen immunoassay codesCPTCovered

87389	Infectious agent antigen detection by immunoassay technique, qualitative or semiquantitative; HIV-1 antigen(s), with HIV-1 and HIV-2 antibodies, single result.
87390	Infectious agent antigen detection by immunoassay technique, qualitative or semiquantitative; HIV-1.
87391	Infectious agent antigen detection by immunoassay technique, qualitative or semiquantitative; HIV-2.
87534	Infectious agent detection by nucleic acid (DNA or RNA); HIV-1, direct probe technique.
87535	Infectious agent detection by nucleic acid (DNA or RNA); HIV-1, amplified probe technique, includes reverse transcription when performed.
87536	Infectious agent detection by nucleic acid (DNA or RNA); HIV-1, quantification, includes reverse transcription when performed.
87537	Infectious agent detection by nucleic acid (DNA or RNA); HIV-2, direct probe technique.
87538	Infectious agent detection by nucleic acid (DNA or RNA); HIV-2, amplified probe technique, includes reverse transcription when performed.
87539	Infectious agent detection by nucleic acid (DNA or RNA); HIV-2, quantification, includes reverse transcription when performed.
87806	Infectious agent antigen detection by immunoassay with direct optical observation; HIV-1 antigen(s), with HIV-1 and HIV-2 antibodies.

Genotype/phenotype and NGS resistance testing codesCPT | ProprietaryCovered

87900	Infectious agent drug susceptibility phenotype prediction using regularly updated genotypic bioinformatics.
87901	Infectious agent genotype analysis by nucleic acid (DNA or RNA); HIV-1, reverse transcriptase and protease regions.
87903	Infectious agent phenotype analysis by nucleic acid with drug resistance tissue culture analysis, HIV-1; first through 10 drugs tested.
87904	Infectious agent phenotype analysis by nucleic acid with drug resistance tissue culture analysis, HIV-1; each additional drug tested.
87906	Infectious agent genotype analysis by nucleic acid (DNA or RNA); HIV-1, other region (e.g., integrase, fusion).
0219U	Targeted viral next-generation sequence analysis (PR, RT, INT), algorithm reported as prediction of antiviral drug susceptibility (Sentosa SQ HIV-1 Genotyping Assay).

Screening HCPCS/G codes and S codeHCPCS | G-code | S-codeCovered

G0432	Infectious agent antibody detection by enzyme immunoassay (EIA) technique, HIV-1 and/or HIV-2, screening.
G0433	Infectious agent antibody detection by enzyme-linked immunosorbent assay (ELISA) technique, HIV-1 and/or HIV-2, screening.
G0435	Infectious agent antibody detection by rapid antibody test, HIV-1 and/or HIV-2, screening.
G0475	HIV antigen/antibody, combination assay, screening.
S3645	HIV-1 antibody testing of oral mucosal transudate.

Assay detectability / virologic thresholds — detectability and decision points

Lower limit of detectabilitySome RT-PCR assays report detectability around 20–40 copies/mL

Clinical decision points referencedHigh agreement near ~50 copies/mL (1.7 log10) and 200 copies/mL (2.0 log10) across assays

Interpretation caution at low VLVariation and error increase at lower limits of quantitation; interpret low-level results cautiously

Viral load thresholds for testing/resistance

>200 copies/mL (DHHS)Genotypic resistance testing generally recommended for virologic failure at HIV‑1 RNA >200 copies/mL; higher strength recommendations for >1,000 copies/mL

Provider Documentation, Prior Authorization, and Operational Notes

Documentation Required

Prior authorization and documentation: Providers should document the clinical indication for HIV testing or resistance assays when ordering to support approval. Orders lacking an explicit clinical indication (e.g., screening context, suspected acute infection, treatment initiation/modification, pregnancy, virologic failure, or suspected multidrug resistance) may be subject to denial or additional review.

Document the clinical indication on the order (screening, confirmatory, acute exposure, monitoring, resistance testing for treatment change, pregnancy-related testing, virologic failure, suspected multidrug resistance).
Repeat testing frequency limits: antibody/antigen testing not more often than every 90 days; NAAT (qualitative/quantitative) not more often than once monthly (Note 1).
When ordering quantitative HIV-RNA for clinical monitoring, note that results should ideally be measured by the same analytical method; assay changes may require re-establishing a baseline.

Prior Authorization

Prior Authorization Required

Clinical Background and Rationale

Human immunodeficiency virus (HIV) is an RNA retrovirus that primarily infects CD4+ lymphocytes, leading to progressive immune dysfunction and, without treatment, acquired immunodeficiency syndrome (AIDS). HIV-1 is the predominant and globally widespread subtype, and most quantitative RNA assays and monitoring strategies are developed for HIV-1. HIV-2 is less common, tends to have a milder clinical course, and may be intrinsically resistant to some drug classes; commercial quantitative assays are more limited for HIV-2. Understanding these subtype differences underpins the policy's recommendations for assay selection, viral load interpretation, and resistance testing.

Definitions and Test Descriptions

HIV-1 definition and context

DefinitionHuman immunodeficiency virus type 1 (HIV‑1): the dominant, globally widespread subtype of HIV that is the primary target of quantitative RNA assays

Clinical roleHIV‑1 RNA (viral load) testing is used for diagnosis in specific settings and for monitoring response to therapy

Assay considerationsMonitoring should be performed on the same technology platform due to inter-assay variability

HIV-2 definition and context

DefinitionHuman immunodeficiency virus type 2 (HIV‑2): less common subtype, often milder clinically with lower plasma viremia and limited commercial quantitative assays

Diagnostic limitationsHIV‑1 assays typically do not reliably detect or quantify HIV‑2; some assays may cross‑react and cause misclassification

Policy Revision History

2025-09-04policy_revisionLatest

Reviewed and updated references, background, and evidence; added new coverage criteria CC3 (screening for PrEP/high-risk individuals) and CC4 (HIV-1/HIV-2 antibody differentiation assay after a positive screen), and CC9 (explicit exclusion of antigen-only testing); consolidated testing frequency limits into a new Note 1 and added Note 2 enumerating risk factors.

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Human Immunodeficiency Virus (HIV)