CAM 20122

Plasma HIV-1 RNA Quantification for HIV-1 Infection

Category:Laboratory   Last Reviewed:April 2019
Department(s):Medical Affairs   Next Review:April 2020
Original Date:November 1996    

Description:
Infection with human immunodeficiency virus type 1 (HIV-1) is followed by a period of clinical latency wherein decreases in CD4+ cells may be minimal for prolonged periods. Progression to symptomatic acquired immunodeficiency syndrome (AIDS) causes CD4+ T-cell counts to decrease. Therefore, the CD4+ assay has become the surrogate for monitoring disease progression and initiating therapy. This count, however, is an imperfect marker of disease progression.


Assays that measure levels of HIV-1 ribonucleic acid (RNA) in plasma for use in managing HIV-1 disease have recently become available. In general, detection and quantification of viral particles involve the target, i.e., HIV RNA, and the use of a signal, typically a complementary strand of nucleic acids, which is labeled so that the resulting complex can be detected and quantified. Since the HIV RNA exists in such small quantities, the resulting complex must be amplified in some way to enable detection. Two basic strategies have been used. In the Amplicor® technique (Roche Molecular System), polymerase chain reaction (PCR) is used to amplify the target HIV RNA. In contrast, in the Quantiplex® technique (Chiron Corporation), the signal is amplified, allowing detection of the HIV RNA in its original physiologic concentration.

Policy:
In clinical situations where risk of HIV infection is significant and initiation of therapy is anticipated, a baseline HIV quantification may be considered MEDICALLY NECESSARY. These situations include:

  • Persistence of borderline or equivocal serologic reactivity in an at-risk individual.
  • Signs and symptoms of acute retroviral syndrome characterized by fever, malaise, lymphadenopathy and rash in an at-risk individual. 

Plasma HIV-1 RNA quantification is considered MEDICALLY NECESSARY for use in monitoring disease progression in HIV-infected individuals.

Plasma HIV-1 RNA quantification is considered MEDICALLY NECESSARY for monitoring response to antiretroviral therapy.

Plasma HIV-1 RNA quantification is considered MEDICALLY NECESSARY and meets coverage criteria for infants younger than 18 months born to HIV-positive mothers, as antibody tests may be confounded by maternal antibodies in this timeframe.

Plasma HIV-1 RNA quantification is considered INVESTIGATIONAL for predicting maternal-fetal transmission of HIV-1.


Policy Guidelines:
Suggested frequency for HIV RNA measurement is:

  • At baseline: 2 measurements, 2 to 4 weeks apart
  • Every 3 to 4 months or in conjunction with CD4+ counts
  • Shorter intervals, as critical decision points are neared
  • Three to 4 weeks after initiating/changing therapy* 

* For prognosis including anti-retroviral therapy monitoring, regular, periodic measurements are appropriate. The frequency of viral load testing should be consistent with the most current Centers for Disease Control and Prevention guidelines for use of anti-retroviral agents in adults and adolescents or pediatrics.

Benefit Application
BlueCard®/National Account Issues
One plasma HIV-1 RNA assay has received approval from the FDA for monitoring disease progression (Amplicor® HIV-1 Monitor HIV-1 plasma RNA quantification test manufactured by Roche Molecular System Inc., Alameda, Calif.). The approval language also acknowledged ongoing evaluation of the use of this assay in monitoring response to antiretroviral therapy. Approval of the Quantiplex® HIV-RNA assay, manufactured by Chiron Corporation, is expected shortly. Other commercial and in-house methods have been described in technical publications and clinical studies.

In 1998, two new CPT codes were introduced to describe viral load testing: CPT code 87535 (HIV-1 amplified probe technique) and 87536 (HIV-1 quantification). Before 1998, a series of CPT codes was used to describe the individual steps in the testing process. The CPT codes differed slightly, depending on whether the Amplicor® or Quantiplex® process was used. The codes are summarized as follows:

Branched DNA signal amplification technology (Quantiplex®, manufactured by Chiron Corporation)
83890: Nuclear molecular diagnostics; molecular isolation or extraction
83896: Nuclear molecular diagnostics; nucleic acid probe, each (typically 2 are used)
83898: Nuclear molecular diagnostics; nucleic acid probe with amplification
82397: Chemiluminescent assay
83912: Nuclear molecular diagnostics; interpretation and report

Polymerase chain reaction (PCR) technology (Amplicor®, manufactured by Roche Molecular Systems):
83890: Nuclear molecular diagnostics; molecular isolation or extraction
83898: Nuclear molecular diagnostics; nucleic acid probe with amplification, e.g., PCR (typically 7 are used)
83912: Nuclear molecular diagnostics; interpretation and report.

References:

  1. Saag MS, Holodniy M, Kuritzkes DR. HIV viral load markers in clinical practice. Nature Med 1996;2(6):625-29

Coding Section

Codes Number Description
CPT 87534 HIV-1 direct probe technique
  87535 HIV-1 amplified probe technique
  87536 HIV-1 quantification
ICD-9 Procedure No Code   
ICD-9 Diagnosis  042 Symptomactic acquired immunodeficieny syndrome (AIDS)
  V08 Asymptomatic HIV infection
HCPCS No Code  
ICD-10-CM (effective 10/01/15)  B20 Human immunodeficiency virus [HIV] disease
  M25.5  Pain in joint 
  R06.03 (effective 1/1/2018)    Acute respiratory distress 
  R07.0  Pain in throat
  R21  Rash and other nonspecific skin eruption 
  R50.09  Fever, unspecified 
  R51  Headache 
  R52  Pain, Generalized pain NOS 
  R53.81  Other malaise 
  R59 Enlarged lymph nodes 
  Z21  Asymptomatic human immunodeficiency virus [HIV] infection status
Type of Service Medicine  
Place of service Inpatient/Outpatient  

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross and Blue Shield Association technology assessment program (TEC) and other non-affiliated technology evaluation centers, reference to federal regulations, other plan medical policies and accredited national guidelines.

"Current Procedural Terminology© American Medical Association.  All Rights Reserved" 

History From 2014 Forward     

04/04/2019 

Annual review, no change to policy intent. 

04/17/2018 

Annual review, updating guidelines to include: * For prognosis including anti-retroviral therapy monitoring, regular, periodic measurements are appropriate. The frequency of viral load testing should be consistent with the most current Centers for Disease Control and Prevention guidelines for use of anti-retroviral agents in adults and adolescents or pediatrics. 

09/28/2017 

Updating coding section with 2018 coding. No other changes. 

06/19/2017 

Updated coding section. No other changes. 

04/25/2017 

Updated category to Laboratory. No other changes

04/17/2017 

Annual review, no change to policy intent. 

02/08/2017 

Annual Review. No change to policy. 

04/07/2016 

Interim review to add a new medical necessity criteria for this testing. No other changes made. 

09/23/2015 

Added ICD-10 codes to policy. 

03/05/2015 

Disclaimer removed. 

02/10/2015 

Annual review, no change to policy intent. Updating benefit application, adding coding. Policy will remain active, but will not undergo scheduled review after 2015. 

02/5/2014

Annual review.  Added guidelines and benefit application. No change to policy intent.

 


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