Comprehensive Guide for HIV Testing in Youth in Florida Healthcare Settings

F/C AETC

Florida / Caribbean AIDS Education and Training Center

Disclaimer Development Team References About Us

The Comprehensive Guide for HIV Testing in Florida Adolescents is a web-based tool designed to provide support to clinicians on testing adolescents for HIV in a clinical setting.

Clinicians can easily access and download the tool to a mobile device and find quick answers to questions and procedures relating to routine HIV testing in adolescents. The tool features HIV testing resources, including CDC’s Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Healthcare Settings; Florida law as it relates to informed consent and pre- and post-test counseling; clinical scenarios; U.S. Preventive Services Task Force recommendations; and the American Academy of Pediatrics position on HIV Screening. The tool also includes important general information on routine HIV testing, insurance coverage plans, specific tests for HIV testing and a list of CPT® codes that may be used for reimbursement of testing products, administration, and services. Global and U.S. morbidity and mortality HIV/AIDS statistics are also provided.

Quick Answers

General Information

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Acute Phase and HIV Screening Expectations

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ABOUT F/C AETC

The Florida/Caribbean AIDS Education and Training Center's mission is to ensure that physicians, nurses, nurse practitioners, physician assistants, dentists, pharmacists, and other healthcare professionals in Florida, Puerto Rico, and the U.S. Virgin Islands receive state-of-the-art information, training, and consultation on the prevention and treatment of HIV and AIDS. Please visit our website at www.FCAETC.org for more information about our resources and training.

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Training, education, and resources are made possible by AETC grant award H4AHA00049 from the HIV/AIDS Bureau (HAB) of the Health Resources Services Administration (HRSA), U.S. Department of Health and Human Services (HHS). The University of South Florida Center for HIV Education and Research operates an AIDS Education and Training Center (AETC) that strengthens the capacity of healthcare professionals to care for people living with HIV/AIDS through training and technical assistance. The information presented is the consensus of HIV/AIDS specialists within the Florida/Caribbean AETC and does not necessarily represent the official views of HRSA/HAB.

References

Centers for Disease Control and Prevention. Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health Care Settings. MMWR 2006; 55(RR14);1-17. Available at http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5514a1.htm. Accessed.

Centers for Disease Control and Prevention. FDA-Approved Rapid HIV Antibody Screening Tests. Divisions of HIV Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention. February 15, 2008. Available at http://www.cdc.gov/hiv/topics/testing/rapid/rt-comparison.htm. Accessed.

Constantine, N. (2006, May). HIV Antibody Assays. HIV InSite Comprehensive,up-to-date information on HIV/AIDS treatment, prevention, and policy from the University of California San Francisco. Available at http://hivinsite.ucsf.edu/InSite?page=kb-02-02-01#S3X. Accessed.

Eaton, D.K., Kann, L., Kinchen, S., et al. Centers for Disease Control and Prevention. Youth Risk Behavior Surveillance: United States, 2009. MMWR Surveill Summ. 2010; 59 (SS-5): 1-142. Available at http://www.ncbi.nlm.nih.gov/pubmed/20520591. Accessed.

Emmanuel, P.J., Martinez, J., et al. Adolescents and HIV Infection: The Pediatrician’s Role in Promoting Routine Testing. Pediatrics, November 2011; 128 (5): 1023-1029. doi: 10.1542/peds.2011-1761 Available at: http://pediatrics.aappublications.org/content/128/5/1023.full. Accessed.

Florida Administrative Register & Florida Administrative Code. Rule: 64D-2.004. Florida Department of State. Available at https://www.flrules.org/gateway/RuleNo.asp?id=64D-2.004. Accessed August 5, 2014.

Florida Department of Health. Infectious Diseases. Bureau of Public Health Laboratories. Sept. 20, 2012. Available at http://www.doh.state.fl.us/lab/. Accessed.

Inungu, J., Lewis, A., Mustafa, Y., Wood, J., O’Brien, S., & Verdun, D. HIV Testing among Adolescents and Youth in the United States: Update from the 2009 Behavioral Risk Factor Surveillance System. The Open AIDS Journal, 2011; 5: 80-85 National HIV/AIDS Clinicians’ Consultation Center. (2011, April 18). Compendium of State HIV Testing Laws. Florida. Available at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3170929/. Accessed.

Laboratory Corporation of America. Test Menu. Available at https://www.labcorp.com/wps/portal/provider/testmenu. Accessed.

OraQuick. In-Home Oral HIV Test. Available at http://www.orasure.com/products-infectious/products-infectious-oraquick.asp. Accessed.

Quest Diagnostics. Test Center. HIV-1 infection: Laboratory tests for selecting antiretroviral therapy. June 2013. Available at http://www.questdiagnostics.com/testcenter/testguide.action?dc=TG_HIV_Antiretroviral_Therapy. Accessed.

United Nations Children’s Fund (UNICEF). (June 2011) Opportunity in Crisis: Preventing HIV from Early Adolescent to Young Adulthood. Available at http://www.unicef.org/search/search.php?q=Opportunity%20in%20Crisis&type=Main. Accessed.

U.S. Food and Drug Administration (FDA). Vaccines, Blood, & Biologics-Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays. Available at http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/BloodDonorScreening/InfectiousDisease/ucm080466.htm Accessed.

U.S. Preventive Services Task Force. Screening for HIV: Current Recommendations. April 2013. Available at http://www.uspreventiveservicestaskforce.org/uspstf/uspshivi.htm. Accessed.

World Health Organization & Joint United Nations Programme on HIV/AIDS (2010). Global Summary of the AIDS Epidemic. Available at http://www.who.int/hiv/data/2011_epi_core_en.png. Accessed.

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Disclaimer

This resource is made possible by AETC grant award H4AHA00049 from the HIV/AIDS Bureau (HAB) of the Health Resources Services Administration (HRSA), U.S. Department of Health and Human Services (HHS). The University of South Florida Center for HIV Education and Research operates an AIDS Education and Training Center (AETC) that strengthens the capacity of healthcare professionals to care for people living with HIV/AIDS through training and technical assistance. The information presented is the consensus of HIV/AIDS specialists within the Florida/Caribbean AETC and does not necessarily represent the official views of HRSA/HAB.

The information contained in this publication is intended for medical professionals, as a quick reference for HIV testing in adolescents. Recognizing the rapid changes that occur in this field, clinicians are encouraged to consult with their local experts or research the literature for the most up-to-date information regarding HIV testing in the adolescent population.

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HIV Testing in Adolescents Resource Development Team

Editor: Managing Editors: Layout: Special Thanks
To:
Jeffrey Beal, MD, AAHIVS
Clinical Director, Florida/Caribbean AETC

Robert M. Lawrence, MD
University of Florida, LPS, Principal Investigator Florida/Caribbean AETC

for their review and contributions
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HIV Screening Methods

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Routine HIV Testing

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American Academy of Pediatrics

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HIV Provider Guidance Tool Survey

Thank you for utilizing our new HIV Provider Guidance Tool. At this time, we would like to gather feedback from healthcare providers regarding their experiences using the tool. We would appreciate your honest responses to the survey questions. Information you provide will be kept confidential.

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Why Adolescents?

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American Academy of Pediatrics (AAP)

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CDC Revised Recommendations for HIV Testing and Florida Law

CDC Revised Recommendations

  • Routine, not risk based, voluntary HIV screening for all persons ages 13 to 64 in all healthcare settings
  • Annual or more frequent repeat HIV screening of persons with known risk.
  • Opt-out HIV screening with the opportunity to ask questions and the option to decline
  • Include HIV consent with general consent for care; separate written informed consent is not required
    • Florida has opt-in screening (except for pregnant woman), requiring documentation ( written or verbal) of consent in the patient's medical record.
  • Prevention counseling in conjunction with HIV screening in healthcare settings is not required unless state law or institutional policy states otherwise.

Screening is intended for all healthcare settings, including inpatient services, emergency departments, urgent care clinics, STD clinics, TB clinics, public health clinics, community clinics, substance abuse treatment centers, correctional health facilities, and primary care settings.

Communicate test results in same manner as other diagnostic/screening tests. Provide clinical HIV care indicated or prevention counseling and referral for services.

CDC Revised Recommendations

Routine HIV Testing

Screening that is performed on a routine basis during all healthcare encounters, irrespective of reasons for patient visit.

Opt-out HIV Screening

"Performing HIV screening upon notifying the patient that the test will be performed; patient may elect to decline or defer testing. Assent is inferred unless patient declines testing."

  • All patients must be informed of planned HIV testing
  • May be verbal or in writing
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Why routine HIV testing?

The need and rationale for following CDC guidance for HIV screening as a Standard of Care is based on the following criteria:

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CDC Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Healthcare Settings

Screening is intended for all healthcare settings, including inpatient services, emergency departments, urgent care clinics, STD clinics, TB clinics, public health clinics, community clinics, substance abuse treatment centers, correctional health facilities, and primary care settings.

Communicate test results in same manner as other diagnostic/screening tests. Provide clinical HIV care or connect to clinical and prevention services.

CDC Revised Recommendations
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Background Information

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Scenarios

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USPSTF policy

Release Date: April 2013
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Screening Intervals

  1. CDC recommends routine HIV screening, one time for adults and adolescents from ages 13-64, unless prevalence is documented to be < 0.1% in patient population.
  2. Persons likely to be at high risk include injection-drug users and their sex partners, persons who exchange sex for money or drugs, sex partners of HIV-infected persons, and MSM or heterosexual persons who themselves or whose sex partners have had more than one sex partner since their most recent HIV test. Women screened during a previous pregnancy should be rescreened in the third trimester and in succeeding pregnancies.
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Clinical Scenarios


Clinical Scenario
Recommended Test(s)
Routine screening/diagnosis of HIV infection
HIV Ab (lab-based or rapid HIV testing) followed by confirmatory WB if reactive or Ag/Ab combo screening IAs
Acute infection
More Information
HIV Ag/Ab combo screening IAs; HIV RNA or HIV proviral DNA NAAT (PCR)
Infant (<18 months of age) born to an HIV-infected mother
HIV RNA or HIV proviral DNA NAAT (PCR)
Indeterminate or negative HIV-1 Western blot following reactive Ab test
HIV RNA or HIV proviral DNA NAAT (PCR); repeat screening IAs and WB in 2 or 3 weeks; perform HIV-2 specific Ab screening IAs and WB
Response to HIV therapy
HIV RNA NAAT (PCR)

IAs: Immunoassays; WB: Western blot; Ag: antigen; Ab: antibody; NAAT: nucleic acid amplification test (or polymerase chain reaction [PCR])
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Coding Scenarios for Routine and Rapid HIV Testing in Health Care Facilities


Providers can bill for performing an HIV test with a rapid test kit by adding modifier "92" for Alternative Laboratory Platform Testing to the usual laboratory procedure code for HIV testing within the CPT® (Current Procedural Terminology) system. The CPT guidance for this modifier is as follows. "When laboratory testing is being performed using a kit or transportable instrument that wholly or in part consists of a single, disposable analytical chamber, the service may be identified by adding modifier "92" to the usual laboratory procedure code (HIV testing 86701-86703)."

Some coding scenario examples are provided below. For additional information regarding billing and coding, see the resource "A Provider's Guide to Sustainability and Reimbursement of HIV Testing in Florida Healthcare Facilities-July 2014" from the USF Center for HIV Education and Research available online at http://usfcenter.org/prevention/HIVTestingSustainabilityGuide.pdf

Example 1: Non-established Patient-Annual Exam
A private practice physician sees a 25-year-old male for his annual wellness exam. The patient, who is not an established patient, states that he has had multiple sexual partners, both male and female. The physician should perform a rapid HIV test.
To bill use:
ICD-10-CM Diagnosis Codes: Z00.00; Z11.59 or Z72.89; Z71.7; Z21; B20

CPT® Codes
Test Product: 86701 with modifier 92 or QW, or 86703 with modifier 92 or QW, or 87390 with modifier 92
Office service: 99385
Example 2: Established Patient
A 35-year-old married female with allergy complaints visits her primary care physician. She is an established patient; therefore, the physician can perform either the conventional or a rapid HIV test.
To bill use:
ICD-10-CM Diagnosis Codes: Z11.59; Z21 or B20; Z71.7
NOTE: These codes should be reported in addition to those codes appropriate to allergy complaints reported by the patient (either a confirmed diagnosis of allergy, or the specific signs or symptoms).

CPT® Codes
Test Product: 86701 with modifier 92 or QW;
Office Service: 99211- 99215
Example 3: Emergency Department visit
A 38-year-old male visits the Emergency Department with a prolonged cough and pain in the chest, and indicates sexual risk behavior. The attending physician can either perform a conventional HIV test or a rapid HIV test.
To bill use:
ICD-10-CM Diagnosis Codes: Z11.59 or Z72.89; Z71.7; Z21; B20;

CPT® Codes
Test product: 86701 with modifier 92, or 86703 with modifier 92, or 87390 with modifier 92
Office Service: 99281-99288

NOTE: Physician billing codes are for emergency department services provided to patient by both the patient's personal physician and/or ED physician.
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Specific Tests

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CPT Codes and Billing

For information regarding HIV testing billing and coding, see the resource "A Provider's Guide to Sustainability and Reimbursement of HIV Testing in Florida Healthcare Facilities" from the USF Center for HIV Education and Research available online at http://www.usfcenter.org/prevention/HIVTestingSustainabilityGuide.pdf
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Implementing HIV Screening in the Healthcare Setting

  1. Review pros and cons of rapid and conventional testing to identify the option that best serves the need of your practice
    1. Rapid testing
      • Test is quick and easy (finger-stick or oral swab)
      • Results are given when patient is meeting with provider
      • No appreciable time added to the patient's visit
      • If a result is non-reactive, the results are considered negative and can be used as an opportunity for HIV prevention
      • If a rapid test is positive, it is only considered "presumptively positive" and a confirmatory HIV test must be performed on a second specimen. Explain to the patient the possibility of a false-positive result and the need of confirmatory testing.
      • May miss acute or recent infections, if at risk behavior occurred in the past 2-3 weeks
      • Can be used in patients difficult to reach (homeless, migrant workers, no phone access)
    2. Conventional testing
      • May work better when providers are already drawing blood for other diagnostic or screening tests, and for patients that have an established relationship with the provider and can be easily located in the event of a positive result.
      • Confirmatory test is already built into the testing panel
  2. Address Patient's Misperceptions
    • Patients may not know the basic facts about HIV. Explain to the patient that they may never have been screened for HIV infection, even if other physicians have performed other blood tests.
    • Emphasize that HIV screening is routine.
  3. Emphasize that HIV screening is routine to your patients and your staff
    • Provide patient informational materials.
    • Discuss HIV testing and opt-out screening with staff and include it on wellness visits.
    • Clinicians and their staff should be able to disclose test results and link patients for ongoing care needs.
      • If negative, does not require direct personal contact. Discuss periodic retesting for persons at high risk and consider incorporating a reminder in your patient's medical record.
      • If positive, provide test results with direct patient contact and confidentially. Inform patient that confirmatory tests may be performed as there is always a possibility of a false-positive result. If true positive, early diagnosis has helped the patient and there is effective treatment. Ensure patient understands test result and connect to services.
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In-Home OraQuick® Test Kit

Test Name Use Specimen Type Sensitivity Specificity Manufacturer
OraQuick®In-Home HIV Test In-vitro diagnostic home-use test for HIV (HIV-1 and HIV-2) Oral Fluid 91.7% 99.9% Manufacturer: OraSure Technologies, Inc.
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Test Product

Test Code Description
86689 Antibody; HTLV or HIV antibody; confirmatory test (e.g., Western blot)
86701 Antibody; HIV-1
86703 Antibody; HIV-1 and HIV-2, single assay
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
87536 Infectious agent detection by nucleic acid (DNA or RNA); HIV-1, quantification
87390 Infectious agent antigen detection by enzyme immunoassay technique, qualitative or semi-qualitative, multiple-step method; HIV-1
87389 HIV-1 antigen(s), with HIV-1 and HIV-2 antibodies, single result (fourth-generation)
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Test Administration

Test Code Description
36415 Collection of venous blood by venipuncture
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Office Service

Test Code Description
99385 Initial comprehensive preventive medicine service evaluation and management 18-39 years of age (new pt.)
99386 Initial comprehensive preventive medicine service evaluation and management 40-64 years of age (new pt.)
99395 Periodic comprehensive preventive medicine reevaluation and management 18-39 years of age (established pt.)
99396 Periodic comprehensive preventive medicine reevaluation and management 40-64 years of age (established pt.)
99211-99215 Office or other outpatient visit for the evaluation and management of an established patient that may not require the presence of a physician
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Rapid HIV Screening Tests

Test Specimen Type CLIA Category Sensitivity** (95%CI) Specificity** (95%CI) Manufacturer
Alere Determine HIV 1/2 Ag/Ab Whole Blood (finger stick or venipuncture) Waived 96% 98.9% Alere, Inc Alere.com
Plasma Non Waived 96% 98.9%
OraQuick® ADVANCE Rapid HIV-1/2 Antibody Test Oral fluid Waived 99.3%
(98.4-99.7)
99.8%
(99.6-99.9)
OraSure Technologies, Inc.
www.orasure.com
Whole blood (finger stick or venipuncture) Waived 99.6%
(98.5-99.9)
100%
(99.7-100)
Plasma Moderate Complexity 99.6%
(98.9-99.8)
99.9%
(99.6-99.9)
Uni-Gold® Recombigen® HIV Whole blood (finger stick or venipuncture) Waived 100%
(99.5-100)
99.7%
(99.0-100)
Trinity Biotech
www.unigold.com
Serum & Plasma Moderate Complexity 100%
(99.5-100)
99.8%
(99.3-100)
Reveal® G3 Rapid HIV-1 Antibody Test Serum Moderate Complexity 99.8%
(99.2-100)
99.1%
(98.8-99.4)
MedMira, Inc. www.medmira.com
Plasma Moderate Complexity 99.8%
(99.0-100)
98.6%
(98.4-98.8)
MultiSpot HIV-1/HIV-2 Rapid Test Serum Moderate Complexity 100%
(99.94-100)
99.93%
(99.79-100)
BioRad Laboratories www.biorad.com
Plasma Moderate Complexity 100%
(99.94-100)
99.91
(99.77-100)
Clearview® HIV 1/2 STAT-PAK Whole blood (finger stick or venipuncture) Waived 99.7%
(98.9-100)
99.9%
(99.6-100)
Alere Inc.
www.alere.com
Serum & Plasma Non-waived 99.7%
(98.9-100)
99.9%
(99.6-100)
Clearview® COMPLETE HIV 1/2 Whole blood (finger stick or venipuncture) Waived 99.7%
(98.9-100)
99.9%
(99.6-100)
Alere Inc.
www.alere.com
Serum & Plasma Non-waived 99.7%
(98.9-100)
99.9%
(99.6-100)
In-Home Test Kit
OraQuick® In-Home HIV Test Oral Fluid Waived 91.7% 99.9% OraSure Technologies, Inc.
www.oraquick.com
Clinical Laboratory Improvement Amendments: CLIA regulations identify three categories of tests: waived, moderate complexity, or high complexity

** Sensitivity is the probability that the test result will be reactive if the specimen is a true positive; specificity is the probability that the test result will be nonreactive if the specimen is a true negative. Data are from the FDA summary basis of approval, for HIV-1 only. For HIV-2 information, see package inserts.
Trade names are for identification purposes only and do not imply endorsement. This information was compiled from package inserts and direct calls to manufacturers.
Content Source:
Divisions of HIV/AIDS Prevention
National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention
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Florida Individual Health Insurance Plans Preventive Services Coverage for HIV Testing

Health Insurance Company Cost Sharing Deductible Reimbursement
Aetna No member cost sharing for in-network service Covered at 100% In-network providers: Allowed amount based on fee schedule. Out-of-network: Recognized amount as defined by member’s plan; member cost-sharing may apply; balance billing allowed. Visit http://www.aetna.com/cpb/medical/data/500_599/0542.html to read the Clinical Policy Bulletin: HIV Testing in its entirety.
AvMed No member cost sharing for in-network service if the member has a new health insurance plan beginning on or after Sept. 23, 2010 Covered at 100% Visit http://www.avmed.org/providers/Tools/Guidelines%20and%20Standards/Preventive%20Services/index.aspx to read provider guidelines and standards.
Florida Blue® No member cost sharing for in-network service Covered at 100% of allowed amount Manual for Physicians and Providers: http://providermanual.bcbsfl.com/Pages/default.aspx
CIGNA® No member cost sharing for in-network service Covered at 100% of allowed amount Visit www.cignaforhcp.com to verify benefit and eligibility information, or call 1.800.882.4462. Some grandfathered plans may not offer screenings. For additional info visit: www.informedonreform.com
Humana® No member cost sharing for in-network service Covered at 100% For a list of covered preventive services under the law, please visit the following website, which is managed by the U.S. Department of Health and Human Services. For specific questions regarding member benefits and applicable cost-share, please call Humana (the number on the back of the member's ID card) prior to rendering services.
United Health Care No member cost sharing for in-network service Covered at 100% of allowed amount For a summary of preventive care services visit: http://www.uhc.com/united_for_reform_resource_center/health_reform_provisions/preventive_services.htm
Note: Preventive services are available to insured members as part of a routine annual wellness exam. Additional laboratory or procedural services may be subject to standard medical plan deductible, coinsurance or copay by the patient.
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Florida Bureau of Public Health Labs

Test Name
Test Number
CPT Code
When to Use Test
Clinical Significance of Test
Fourth-generation Abbott HIV-1/2 Ag/Ab screening immunoassay (Jacksonville & Miami Labs) 0500 87389 For routine blood screening to detect both acute and established HIV-1 infections as well as HIV-2 infections. Able to detect Fiebig stage II (15-17 day window) cases. Together with the supplemental test and the qualitative RNA test, results can differentiate acute from established HIV-1 infections. Acute HIV infections can be linked to increased HIV incidence.
Multispot HIV-1/2 Supplemental immunoassay (Jacksonville & Miami Labs) Included in 0500, if needed 86703 Supplemental test in the confirmatory process for the HIV 4th generation screening immunoassay. In addition it is able to differentiate between HIV-1 and HIV-2 antibody reactivity. Together with the supplemental test and the qualitative RNA test, results can differentiate acute from established HIV-1 infections. Acute HIV infections can be linked to increased HIV incidence. This test alone can differentiate HIV-1 from HIV-2 antibody reactivity.
APTIMA HIV-1 RNA Qualitative NAAT (Jacksonville Lab) 0530 83898 Used when 4th generation Abbott HIV-1/2 Ag/Ab screening immunoassay and Multispot HIV-1/2 Supplemental immunoassay are discordant, defines an acute HIV-1 infection or resolves false positive screening tests. Also a primary test with occupational exposure cases. An RNA test alone cannot discriminate an acute HIV infection from an established infection. However used in a 4th generation based algorithm, an RNA test is able to establish disease staging.
Avioq HIV-1 Ab EIA (oral fluid and dried blood spot use only) (Jacksonville & Miami Labs) 0500 86701 A 2nd generation HIV-1 antibody only screening test used exclusively with HIV OraSure Collection Devices or dried blood spots (DBS). Currently the only FDA approved HIV-1 antibody test for use with OraSure (oral fluid) Collection Devices and DBSs. These alternatives to blood specimen types are sometimes used in HIV outreach and surveillance activities.
OraSure® HIV-1 Western blot (oral fluid use only) (Jacksonville & Miami Labs) Included in 0500, if needed 86689 Supplemental test in the confirmatory process Avioq HIV-1 Ab EIA (oral fluid and dried blood spot use only) exclusively for HIV OraSure Collection Devices or DBSs. Currently the only FDA approved HIV-1 antibody supplemental test in the confirmatory process for OraSure specimens repeatedly reactive by Avioq HIV-1 Ab EIA (oral fluid and dried blood spot use only).
VERSANT® HIV-1 RNA 3.0 Assay (bDNA)(Jacksonville Lab) 0560 87536 This assay is used when an individual is diagnosed with HIV-1 and is linked and retained in care. Viral load testing detects and quantifies HIV-1 RNA level. HIV-1 genotyping determines if the HIV-1 virus is wild-type or indicates resistance to one or more antiretrovirals. CD4/CD8 absolute counts add to the viral load values in determining treatment This assays is vital in the clinical management of an HIV diagnosed individual. Treatment decisions are often based on CD4 and viral load level guidelines (DHHS & IAS). All 3 assays are now recommended for baseline clinical management care on newly diagnosed individuals.
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Quest Diagnostics®

Test Name
Test Number
CPT Code
When to Use Test
Clinical Significance of Test
HIV-1/2 Antigen and Antibodies, Fourth Generation, with Reflexes 91431 87389 To detect acute HIV infection 4 to 12 days earlier than third-generation assays. Together with supplemental tests and clinical information, this cascade can help decrease the spread of HIV infection.
HIV Antibody, HIV-1/2, EIA with Reflexes 19728 86703

86689: If HIV-1/HIV-2 EIA Antibody Screen is reactive, HIV-1 Antibody Western blot will be performed at an additional charge.>

86702: If HIV-1 antibody, Western blot is negative or indeterminate, HIV-2 Antibody EIA will be performed at additional charge>

86689: If HIV-2 Antibody EIA is reactive, HIV-2 Antibody Western blot will be performed at an additional charge.
HIV-1/2 EIA Antibody Screen includes testing for HIV-1 Group O. Combination of HIV-1/HIV-2 includes detection of subtypes of HIV-1 not included in HIV-1, EIA alone. Repeatedly positive results are confirmed by the highly specific Western blot.
HIV-1 RNA, Quantitative, Real-Time PCR 40085 87536 Can be used to assess patient prognosis by measuring the baseline HIV-1 RNA level or to monitor the effects of antiretroviral therapy by measuring changes in EDTA plasma HIV-1 RNA levels during the course of antiretroviral treatment. Not intended for use as a screening test for the presence of HIV-1 in blood or blood products or as a diagnostic test to confirm the presence of HIV-1 infection. Intended for use in conjunction with clinical presentation and other lab markers of disease progress for the clinical management of HIV-1 infected patients.
HIV-1 DNA, Qualitative, PCR 8401 87535 This test should not be used for diagnosis without confirmation by other medically established means. HIV-1 DNA PCR is a sensitive method for detection of pro-viral DNA. It has been used in the management of perinatal HIV infection. HIV-1 RNA has recently been confirmed equally as sensitive and specific for this purpose.
The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party.
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LabCorp

Test Name
Test Number
CPT Code
When to Use Test
Clinical Significance of Test
Human Immunodeficiency Virus 1/O/2 Antigen/Antibody (fourth-generation) Preliminary Test With Cascade Reflex to Supplementary Testing 083935 87389

If reflex testing is performed, additional charges/CPT codes may apply.
To detect acute HIV infection 4 to 12 days earlier than third-generation assays. Together with supplemental tests and clinical information, this cascade can help decrease the spread of HIV infection.
Human Immunodeficiency Virus 1/O/2 (HIV1/O/2) Antibodies, Preliminary Test With Confirmation 083824 86703 Uses recombinant antigen sources and detects antibodies by specific immune binding and subsequent chemiluminescent reaction (ICMA technology). Sera which are repeatedly reactive in two out of three tests are subject to confirmatory HIV-1 testing by the Western blot method. Some individuals may be initially reactive by the preliminary test and negative or indeterminate by Western blot. This may be caused by other viral antibodies or autoantibodies which cross react with the viral antigens, although extremely rarely
Human Immunodeficiency Virus 1 (HIV-1), DNA RT-PCR With HIV Antibodies, ICMA 162100 7535

This procedure may be considered by Medicare and other carriers as investigational and, therefore, may not be payable as a covered benefit for patients.
Detect HIV-1 proviral DNA; detect and confirm antibodies to HIV-1/O/2
Human Immunodeficiency Virus 1 (HIV-1) Quantitative, Real-time PCR (Nongraphical 550430 87536 Detect and quantitate HIV-1 in plasma
Human Immunodeficiency Virus 1 (HIV-1), RNA (bDNA) 162164 87536 Used for quantification of HIV-1 RNA in plasma of HIV-1 infected individuals. HIV-1 RNA results can be used to assess prognosis of disease progression and to monitor the efficacy of antiretroviral therapy by measuring changes in HIV-1 RNA levels during the course of therapy.
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Explanation of

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Information

Acute HIV Infection

A proportion of patients with acute HIV infection may present with the following symptoms suggestive of acute retroviral syndrome within 2-6 weeks post high-risk HIV exposure,

  1. Fever
  2. Lymphadenopathy
  3. Skin rash
  4. Myalgia/arthralgia
  5. Headache
  6. Diarrhea
  7. Oral Ulcers
  8. Leucopenia
  9. Thrombocytopenia
  10. Transaminase elevation
  11. Aseptic meningitis

Differential diagnosis include: EBV and non-EBV related infectious mononucleosis syndromes; viral hepatitis (A, B, C); streptococcal infection; influenza infection, syphilis.

Testing: Due to the delay in development of HIV antibodies against infection, an individual may have a negative HIV ELISA during the so called “window period.” To detect early infection, nucleic acid detection or Antigen/Antibody combination (fourth-generation Ag/Ab combo) should be used decreasing detection time to 1 (RNA testing) or 2-3 weeks (Ag/Ab combo), respectively.


Modified from Fiebig, et.al. AIDS 2003; 17(13): 1871-9
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