CurrentAetnaPolicy 0542

HIV Testing

Clinical policy describing medical necessity, allowable tests, coding, and limitations for HIV screening and diagnostic testing; applies to Aetna-covered members and laboratories performing HIV tests.

Policy Summary

PayerAetna

PolicyHIV Testing

Policy CodePolicy 0542

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionBegin HIV testing with an FDA-approved antigen/antibody combination immunoassay and follow with differentiation immunoassay and HIV-1 NAT as indicated.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

13-64CDC screening age range

>=1%High-prevalence threshold

99.6%OraQuick sensitivity

233OFOQ false-negatives

70%Hands-on time reduction

Coverage and Medical Necessity Criteria

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Medical Necessity Criteria

Aetna considers HIV testing medically necessary when ANY of the following conditions are met or when testing follows the CDC/USPSTF algorithm:

Medical necessity screening indications: 1. Screening per USPSTF and CDC recommendations (routine screening of persons as recommended).

Refer to USPSTF/CDC guidance for population-specific recommendations.

Initial laboratory screening test: 2. Initial testing with an FDA-approved antigen/antibody combination immunoassay that detects HIV-1 and HIV-2 antibodies and HIV-1 p24 antigen; no further testing required for specimens nonreactive on the initial immunoassay.

Use serum or plasma specimens for laboratory immunoassays.

Reflex differentiation testing: 3. For specimens with a reactive (or repeatedly reactive, per manufacturer/regulatory guidance) antigen/antibody combination immunoassay result, perform an FDA-approved HIV-1/HIV-2 antibody differentiation immunoassay to distinguish HIV-1 from HIV-2 antibodies; interpret concurrent reactive results as positive for HIV-1, HIV-2, or undifferentiated HIV antibodies.

Laboratories should follow manufacturer and regulatory repeat-testing recommendations as applicable.

Nucleic acid testing (NAT) after discordant differentiation: 4. If initial antigen/antibody combination immunoassay is reactive and the HIV-1/HIV-2 antibody differentiation immunoassay is nonreactive or indeterminate, perform an FDA-approved HIV-1 nucleic acid test (NAT) with the following interpretive rules: (a) reactive NAT + nonreactive differentiation = laboratory evidence of acute HIV-1 infection; (b) reactive NAT + indeterminate differentiation = HIV-1 infection confirmed by NAT; (c) negative NAT + nonreactive or indeterminate differentiation = false-positive initial immunoassay.

Follow the CDC-recommended algorithm for sequencing immunoassays and NAT.

Acceptable alternative point-of-care/oral tests: 5. The Orasure oral HIV test kit (OraSure) and the OraQuick Rapid HIV-1/2 antibody point-of-care test are acceptable alternatives for the same medically necessary indications as standard laboratory HIV testing.

Specimens submitted to laboratories after a reactive rapid test should be tested beginning with an antigen/antibody combination immunoassay.

Aetna does not cover home HIV test kits that do not require a physician's prescription under any plans. Examples of non-covered kits include the Confide Home HIV Test (Johnson & Johnson) and the Home Access HIV Test System.

Studies of the OraQuick oral fluid rapid test (OFOQ) identified a substantial number of false-negative results in longitudinal cohorts. In these analyses there were 233 false-negative OFOQ results among seroconverting participants and delays in oral-fluid conversion with a median of 98.5 days. Because OFOQ failures were frequent and multifactorial, the policy recommends that negative oral fluid rapid test results in longitudinal trials be confirmed by blood testing (e.g., NAAT or enzyme immunoassay).

Billing and Code Sets

Covered CPT codesCPTCovered

86689	HTLV or HIV antibody, confirmatory test (e.g., Western Blot)
86701	Qualitative or semiquantitative immunoassay performed by multiple step methods for the detection of antibodies to infectious agents; HIV-1
86702	Qualitative or semiquantitative immunoassay performed by multiple step methods for the detection of antibodies to infectious agents; HIV-2
86703	Antibody; HIV-1 and HIV-2, single result
87389	Infectious agent antigen detection by immunoassay technique (eg, EIA, ELISA, IMCA) qualitative or semiquantitative, multiple-step method; HIV-1 antigen(s), with HIV-1 and HIV-2 antibodies, single result
87390	HIV-1
87391	HIV-2
87534	Infectious agent detection by nucleic acid (DNA or RNA); HIV-1, direct probe technique
87535	HIV-1, amplified probe technique, includes reverse transcription when performed
87536	HIV-1, quantification, includes reverse transcription when performed

1–10 of 11

1/2

Covered HCPCS codesHCPCSCovered

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

Covered ICD-10 codesICD-10Covered

B20	Human immunodeficiency virus [HIV] disease
Z11.4	Encounter for screening for human immunodeficiency virus [HIV]
Z20.6	Contact with and (suspected) exposure to human immunodeficiency virus [HIV]
Z20.828	Contact with and (suspected) exposure to other viral communicable diseases
Z21	Asymptomatic human immunodeficiency virus [HIV] infection status

High-prevalence definition

High-prevalence definitionSettings with 1% or greater prevalence of HIV infection in the patient population served.

Source guidanceDefinition provided by the Centers for Disease Control and Prevention (CDC) as referenced in policy background.

Use in screening strategyClinicians should consider local prevalence when determining appropriate screening approaches in high-prevalence settings.

Provider Actions, Billing Guidance, and Laboratory Algorithm

Billing Rule

Billing codes listed — bill with listed codes when criteria met

CPT, HCPCS, and ICD-10 codes listed in this policy are covered when the clinical and testing-algorithm criteria in the policy are met. Providers should bill using the codes shown in the policy for the corresponding tests.

Covered CPT/HCPCS/ICD-10 codes are listed in the policy (see CPT codes such as 86689, 86701-86703, 87389-87391, 87534-87536, 87806; HCPCS codes such as G0432, G0433, G0435, G0475, S3645; ICD-10 codes such as B20, Z11.4, Z20.6, Z20.828, Z21).

Prior Authorization

Prior authorization

No prior authorization requirements are specified in the policy excerpts for these HIV testing services.

Note

Testing algorithm and laboratory actions

Laboratories and providers must follow the CDC-recommended testing algorithm beginning with an FDA-approved antigen/antibody (Ag/Ab) combination immunoassay for initial screening. Specimens nonreactive on the initial Ag/Ab test require no further testing. Reactive (preliminary positive) initial Ag/Ab results should be followed by an FDA-approved HIV-1/HIV-2 antibody differentiation immunoassay. If the differentiation immunoassay is nonreactive or indeterminate after a reactive initial Ag/Ab result, an FDA-approved HIV-1 nucleic acid test (NAT) should be performed to resolve acute infection versus false positive.

Initial test: FDA-approved Ag/Ab combination immunoassay (HIV-1/HIV-2 antibodies and HIV-1 p24 antigen).
If initial Ag/Ab is nonreactive: no further testing required.
If initial Ag/Ab is reactive: perform FDA-approved HIV-1/HIV-2 antibody differentiation immunoassay.
If differentiation immunoassay is nonreactive or indeterminate after reactive initial Ag/Ab: perform an FDA-approved HIV-1 NAT to distinguish acute infection from false-positive results.

Note

Algorithm sequencing

Algorithm sequencing must be followed as specified: start with the Ag/Ab combination immunoassay; follow reactive results with the HIV-1/HIV-2 antibody differentiation immunoassay; if differentiation is nonreactive or indeterminate, perform an HIV-1 NAT. This sequencing determines interpretation (established infection, acute infection, or false-positive initial result).

Step Therapy

Step therapy

No step therapy requirements are described in the provided policy excerpts for HIV testing.

Documentation Required

Provider and documentation requirements

No additional provider-specific requirements or explicit documentation requirements are specified in these chunks beyond following the testing algorithm and using the listed billing codes when criteria are met.

Denial Risk

Non-covered home HIV test kits

Aetna does not cover over-the-counter home HIV test kits that do not require a physician prescription (examples listed in the policy include the Confide Home HIV Test and the Home Access HIV Test System).

Non-covered examples: Confide Home HIV Test; Home Access HIV Test System.

Background and Scope

HIV testing is indicated for persons with risk factors and for routine screening consistent with USPSTF and CDC recommendations. CDC guidance supports routine, opt-out screening in healthcare settings for most adolescents and adults, and the USPSTF has issued Grade A recommendations for screening in specified age ranges.

Screening in pregnancy is included in these recommendations; all pregnant women should be screened for HIV as part of routine prenatal care.

Laboratories and clinicians are advised to follow the CDC-recommended testing algorithm, beginning with an FDA-approved antigen/antibody combination (fourth-generation) immunoassay to improve detection of acute infection, with reflex differentiation immunoassays and nucleic acid testing (NAT) as indicated.

Definitions and Key Terms

Opt-out screening

DefinitionOpt-out screening: routine HIV screening performed after the patient is notified that testing will be performed unless the patient declines.

CDC-recommended age rangePatients aged 13 to 64 years (CDC recommendation for routine opt-out screening).

Pregnancy recommendationCDC recommends opt-out screening for pregnant women as part of routine prenatal screening.

Fourth‑generation HIV test

DefinitionFourth-generation HIV test: an FDA-approved antigen/antibody combination immunoassay that detects HIV-1 and HIV-2 antibodies and the HIV-1 p24 antigen.

PurposeImproves detection of acute HIV-1 infection and screens for established HIV-1 or HIV-2 infection; laboratories should begin testing algorithms with an Ag/Ab combination immunoassay.

Test examplesLaboratory immunoassays such as the ARCHITECT HIV Ag/Ab Combo and lateral-flow Ag/Ab combo tests (e.g., Determine HIV 1/2 Ag/Ab Combo) are implementations of this approach.

HIV self‑testing

DefinitionHIV self-testing (home-based testing): use of an FDA-approved rapid test kit by individuals to perform HIV screening at home, with or without assistance from community health workers.

FDA-approved exampleOraQuick In-Home HIV Test is the only oral HIV self-test kit currently FDA-approved and available for retail sale (as noted in the policy).

Potential benefitsMay increase convenience, privacy, and uptake of testing in some populations; research on implementation strategies is ongoing.

OFOQ false‑negative (oral fluid OraQuick) definition

DefinitionOFOQ false‑negative: an oral fluid OraQuick rapid test result that is negative for HIV antibodies while contemporaneous NAAT and/or enzyme immunoassay indicate HIV infection (i.e., failure to detect infection).

Observed frequency and delayIn longitudinal analyses, 233 false‑negative OFOQ results occurred among seroconverting individuals; estimated conversion delay ranged from 14.5 to 547.5 days (median 98.5 days).

Contributing factorsFalse negatives were associated with test operator/site, pre-exposure prophylaxis, low plasma viral load, and time to kit expiration; age, gender, and HIV subtype were not associated.

Recommended actionNegative oral fluid results in longitudinal trials should be confirmed by testing blood samples due to frequent and multifactorial failures of oral fluid tests.