Download HUMAN IMMUNODEFICIENCY VIRUS (HIV) TESTING, DIAGNOSIS

MEDICAL POLICY
For use with the UnitedHealthcare Laboratory Benefit Management Program, administered by BeaconLBS
HUMAN IMMUNODEFICIENCY VIRUS (HIV) TESTING, DIAGNOSIS
Policy Number: CMP - 003
Effective Date: January 21, 2017
Table of Contents
BACKGROUND
POLICY
REFERENCES
POLICY HISTORY/REVISION HISTORY
Page
1
3
5
6
INSTRUCTIONS FOR USE
This Medical Policy provides assistance in interpreting UnitedHealthcare benefit plans. When deciding
coverage, the enrollee specific document must be referenced. The terms of an enrollee's document (e.g.,
Certificate of Coverage (COC) or Summary Plan Description (SPD)) may differ greatly. In the event of a conflict,
the enrollee's specific benefit document supersedes this Medical Policy. All reviewers must first identify
enrollee eligibility, any federal or state regulatory requirements and the plan benefit coverage prior to use of
this Medical Policy. Other Policies and Coverage Determination Guidelines may apply. UnitedHealthcare
reserves the right, in its sole discretion, to modify its Policies and Guidelines as necessary. This Medical Policy is
provided for informational purposes. It does not constitute medical advice.
UnitedHealthcare may also use tools developed by third parties, such as the MCG™ Care Guidelines, to assist us
in administering health benefits. The MCG™ Care Guidelines are intended to be used in connection with the
independent professional medical judgment of a qualified health care provider and do not constitute the
practice of medicine or medical advice.
BACKGROUND
Diagnosis of HIV is important for decreasing disease transmission and prolonging life with antiretroviral therapy.
Because patients with acute infection have the greatest risk of transmitting disease, early detection is important.
In terms of disease detection, there are three strategies for diagnosis of infection with HIV: screening, targeted
testing, and diagnostic testing. Screening entails offering the test to all persons in a given population, even those
without symptoms or known risk factors. The Centers for Disease Control and Prevention (CDC) currently
recommends that all patients aged 13-64 seeking health care for any reason undergo testing, but the U.S.
Preventive Services Task Force (USPTF) does not embrace this recommendation. Both the CDC and the USPTF
recommend universal antenatal screening of pregnant women to prevent perinatal transmission by identifying
women who should be treated with antiretroviral therapy during pregnancy. The second strategy, targeted
testing, is testing that is carried out when the patient has a known risk factor for disease, based on patient
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characteristics including behavioral practices and/or demographic information. An example of targeted testing is
HIV testing of men who have sex with men. The CDC’s recommendation for HIV testing of all patients presenting
with sexually transmitted disease is another example of targeted testing. The third strategy, diagnostic testing, is
testing carried out when a patient has signs or symptoms of HIV.
Given the plethora of signs and symptoms of HIV, there are many clinical indicators that warrant diagnostic HIV
testing. These situations include the presence of symptoms or signs of disease that are characteristic of
immunosuppression, such as Pneumocystis jiroveci pneumonia, Kaposi’s sarcoma, and opportunistic infections;
the presence of signs or symptoms of diseases that are a function of low functioning immune system but that
frequently occur in the general population, such as chronic sinusitis; and the presence of more severe cases of
diseases usually seen in the general population, including tuberculosis and complications of varicella infection.
The CDC recommends HIV testing for all patients presenting with tuberculosis.
Tests for the diagnosis of HIV include serologic tests to detect patient antibodies and viral tests to detect viral
antigen or viral nucleic acid. There are two phases of testing, beginning with an initial sensitive test (most
commonly a rapid enzyme immunoassay) and supplemented by a specific test for antibody (Western blot) or virus
detection (plasma HIV RNA). Using a nucleic acid test as the supplemental test carries two advantages: detecting
patients still in the window period when antibodies to HIV are not detectable and establishing baseline viral load.
After the initial test, a reactive antibody test positive result is considered a preliminary positive test result until
confirmed by additional testing. A supplemental test, either serologic or viral, should be used to confirm all
reactive screening tests. A person is considered HIV-positive only after a confirmed positive test result. If the
initial test is negative and acute HIV is suspected, a nucleic acid supplemental test is still warranted.
In several unique situations, serologic testing alone may not reliably establish an HIV infection. This may occur
because the antibody response (particularly the IgG response detected by Western Blot) has not yet developed
(that is, acute retroviral syndrome), or is persistently equivocal because of inherent viral antigen variability. It is
also an issue in perinatal HIV infection due to transplacental passage of maternal HIV antibody. In these
situations, laboratory evidence of HIV in blood by culture, antigen assays, or proviral DNA or viral RNA assays, is
required to establish a definitive determination of HIV infection.
Patients with acute HIV infection will have a negative antibody test and a positive HIV RNA test. They can present
with a characteristic set of symptoms (acute retroviral syndrome) that may include fever, malaise, sore throat,
headache, skin rash and lymphadenopathy. Not all patients with acute HIV will report these symptoms, and if a
provider suspects acute HIV, a nucleic acid test should be performed. Patients with acute HIV are highly
contagious; early diagnosis and treatment can decrease the risk of transmission.
Diagnostic testing to establish HIV infection may be indicated when there is a strong clinical suspicion supported
by one or more of the following clinical findings:
1.
The patient has a documented, otherwise unexplained, AIDS-defining or AIDS-associated
opportunistic infection.
2.
The patient has another documented sexually transmitted disease which identifies significant risk
of exposure to HIV and the potential for an early or subclinical infection.
3.
The patient has documented acute or chronic hepatitis B or C infection that identifies a significant
risk of exposure to HIV and the potential for an early or subclinical infection.
4.
The patient has a documented AIDS-defining or AIDS-associated neoplasm.
5.
The patient has a documented AIDS-associated neurologic disorder or otherwise
unexplained dementia.
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6.
The patient has another documented AIDS-defining clinical condition, or a history of other
severe, recurrent, or persistent conditions which suggest an underlying immune deficiency (for
example, cutaneous or mucosal disorders).
7.
The patient has otherwise unexplained generalized signs and symptoms suggestive of a chronic
process with an underlying immune deficiency (for example, fever, weight loss, malaise,
fatigue, chronic diarrhea, failure to thrive, chronic cough, hemoptysis, shortness of breath, or
lymphadenopathy).
The patient has otherwise unexplained laboratory evidence of a chronic disease process with an
underlying immune deficiency (for example, anemia, leukopenia, pancytopenia, lymphopenia, or low
CD4+ lymphocyte count).
8.
9.
The patient has signs and symptoms of acute retroviral syndrome with fever, malaise,
lymphadenopathy, and skin rash.
10. The patient has documented exposure to blood or body fluids known to be capable of transmitting
HIV (for example, needlesticks and other significant blood exposures) and antiviral therapy is initiated
or anticipated to be initiated.
11. The patient is undergoing treatment for rape. (HIV testing is part of the rape treatment protocol.)
POLICY
BeaconLBS recommends that for the following CPT code(s) in Table 1, the patient should have a diagnosis
(ICD-10-CM) code(s) listed in the attached files below.
Table 1. HCPCS Codes (Alphanumeric, CPT AMA)
HCPCS Code
Description
86689
Qualitative or semiquantitative immunoassays performed by multiple
step methods; HTLV or HIV antibody, confirmatory test (for example,
Western Blot)
86701
Antibody; HIV-1
86702
Antibody; HIV-2
86703
Antibody; HIV-1 and HIV-2, single assay
87390
Infectious agent antigen detection by enzyme immunoassay
technique, qualitative or semiquantitative, multiple step method;
HIV-1
87391
Infectious agent antigen detection by enzyme immunoassay
technique, qualitative or semiquantitative, multiple step method;
HIV-2
87534
Infectious agent detection by nucleic acid (DNA or RNA); HIV-1, direct
probe technique
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87535
Infectious agent detection by nucleic acid (DNA or RNA); HIV-1,
amplified probe technique
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
87806
HIV-1 antigen(s), with HIV-1 and HIV-2 antibodies
ICD-10 Diagnosis Codes (Proven)
CMP-003 HIV
Diagnosis ICD10
Limitations
1.
HIV antibody testing in the United States is usually performed using HIV-1 or HIV-½ combination tests.
HIV-2 testing is indicated if clinical circumstances suggest HIV-2 is likely (that is compatible clinical
findings and HIV-1 test negative). HIV-2 testing may be indicated in areas of the country where there is
greater prevalence of HIV-2 infections.
2.
The Western Blot test should be performed only after documentation that the initial EIA tests are
repeatedly positive or equivocal on a single sample.
3.
Direct viral RNA detection may be performed in those situations where serologic testing does not
establish a diagnosis but strong clinical suspicion persists (for example, acute retroviral
syndrome, nonspecific serologic evidence of HIV, or perinatal HIV infection).
4.
If initial serologic tests confirm an HIV infection, repeat testing is not indicated.
5.
If initial serologic tests are HIV EIA negative and there is no indication for confirmation of infection by
viral RNA detection, the interval prior to retesting is 3-6 months.
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REFERENCES
1. Centers for Disease Control and Prevention. Sexually Transmitted Diseases Treatment Guidelines, 2015.
MMWR Recomm Rep 2015;64(No. RR-3): 1-137.
2. CDC, Division of HIV/AIDS Prevention. Recommended HIV testing definitions and examples of HIV Testing
Definitions Work Group. Available at: http://www.cdc.gov/hiv/topics/funding/PS121201/pdf/Attachment- II.pdf. Updated March 29, 2011. (Accessed: October 1, 2016).
3. The Medical Care Criteria Committee. http://www.hivguidelines.org/clinical-guidelines/adults/diagnosisand-management-of-acute-hiv-infection/ Updated September 2015. (Accessed: October 1, 2016).
4. Branson BM, Handsfield HH, Lampe MA, et al. Revised recommendations for HIV testing of adults,
adolescents, and pregnant women in health-care settings. Atlanta, GA: Centers for Disease Control
and Prevention. MMWR 2006;55(RR14):1-17.
5. Centers for Medicare and Medicaid Services (CMS) Medicare National Coverage Determinations
(NCD) Coding Policy Manual and Change Report dated October 2011. Available at:
https://www.cms.gov/CoverageGenInfo/04_LabNCDs.asp#TopOfPage (Accessed: October 1, 2016).
6. CDC. Revised classification system for HIV infection and expanded surveillance case definition for
AIDS among adolescents and adults. MMWR. 1993;41 (No. RR17).
7. CDC. Revised classification system for human immunodeficiency virus infection in children less than 13
years of age; Official authorized addenda: human immunodeficiency virus infection codes and official
guidelines for coding and reporting ICD-9-CM. MMWR. 1994;43 (No. RR12).
8. Piatak M, Saag MS, Yang LC, et al. High levels of HIV-1 in plasma during all stages of infection determined
by competitive PCR. Science. 1993;259:1749-1754.
9. Rhame RS. Acquired immunodeficiency syndrome, p. 628-652. In: Infectious Diseases; Hoeprich PD,
Jordan MC, Ronald AR (eds). (J.B. Lippincott Co., Philadelphia). 1994.
10. Vasudevachari MD, Davey, Jr. RT, Metcalf JA, Lane HC. Principles and procedures of human
immunodeficiency virus serodiagnosis. In: Manual of Clinical Laboratory Immunology (Fifth ed.); Rose NR,
de Macario EC, Folds JD, Lane HC, Nakamura RM. (ASM Press, Washington, DC). 1997.
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POLICY HISTORY/REVISION HISTORY
Date
Action/Description
01/21/2017
Updated ICD10 codes as per CMS recommendations. Removed ICD9 code file.
10/01/2016 Annual Policy Review Completed- Changes made:
Updated CDC STD guidelines from version 2010 to 2015.
Added hivguidelines.org 2015 HIV updates.
12/03/2015 Annual Policy Review Completed – changes made:
Added codes for pregnancy and persons at high risk:
ICD9 Codes added: V01.9, V28.9, V73.99
ICD10 Codes added: Z11.59, Z20.9, Z36
10/01/2015 Removed ICD9 code table. Embedded ICD9/ICD10 PDF files.
Added CPT code 87806 as per 2015 AMA updates.
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