CAM 20410

Identification of Microorganisms Using Nucleic Acid Probes

Category:Laboratory   Last Reviewed:October 2018
Department(s):Medical Affairs   Next Review:October 2019
Original Date:July 1998    

Description: 
Nucleic Acid hybridization technologies “are based on simple structure of DNA which is composed of four repeating nucleotides, adenine, guanine, cytosine and thymine. DNA is coiled to form a double helix strand and composed of two strand sheld together by hydrogen bonds these bonds are pH and heat labile.DNA fragments from different sources with similar sequences anneal together to form double stranded DNA and this process is called hybridization” (Khan,2014).    

Background 
Nucleicacid hybridization technologies are beneficial for pathogendetection in blood culture and other clinical specimens rapidly and reliably (Khan, 2014). Identification of micro- organisms using nucleic-acid based methodologies have several advantages over traditional microbiological techniques for pathogen detection. Nucleicacid hybridization offers increased sensitivity and specificity, including specific organism detection (Mothershed & Whitney,2005).

Regulatory Status 
A list of current U.S. Food and Drug Administration (FDA) ‒ approved or cleared nucleic acid-based microbial tests is available at: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/ucm330711.htm

The Association of Molecular Pathology (AMP) website also provides a list of current FDA approved tests for diagnosis of infectious diseases (available online at: http://www.amp.org/FDATable/FDATable.pdf). Table 2 lists tests that are FDA-approved/cleared but do not have specific CPT codes.

Table 2: FDA-Approved/Cleared Tests without CPT Codes

Human Genetic Tests: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/ucm330711.htm

Microbial Tests: (Table below updated 5/2017)  

Microorganism

Trade Name     

Manufacturer

Adenovirus  

Adenovirus R-gene US Argene SA

 

 ProAdeno+ Assay

Gen-Probe Prodesse, Inc.

 Bacillus Anthracis

JBAIDS Anthrax Detection System Idaho Technology, Inc.

 Candida tropicalis /

Affirm VPIII Microbial Identification Test Microprobe Corp.

 Candida albicans /

 

 

 Candida parapsilosis /

 

 

 Candida glabrata /

 

 

 Candida krusei

 

 

 

Yeast Traffic Light PNA FISH

AdvanDx, Inc.

 

C. albicans / C. glabrata PNA FISH AdvanDx, Inc.

 

C. albicans PNA FISH

.AdvanDx, Inc.

 

C. Albicans screen

Carr-Scarborough Microbiologicals, Inc.
Clostridium difficile ICEPlex C. difficile Kit .PrimeraDx
  IMDx C. difficile for Abbott m2000 Intelligent Medical Devices, Inc.
  BD Diagnostics BD MAX Cdiff Assay   GeneOhm Sciences Canada Inc.
  Quidel Molecular Direct C. difficile Assay   Quidel Corporation
  Verigene C. Difficile Nucleic acid Test   Nanosphere, Inc.
  Portrait Toxigenic C. difficile Assay Great Basin Scientific, Inc.
  Simplexa C. difficile Universal Direct Assay  Focus Diagnostics, Inc.
  Xpert C. difficile/Epi  Cepheid
  Illumigene C. difficile DNA Amplification  Assay Meridian Bioscience, Inc
  Illumigene C. difficile Assay   Meridian Bioscience, Inc.
  Xpert C. difficile   Cepheid
  ProGastro Cd Assay Prodesse Inc.
  BD GeneOhm C. diff Assay BD Diagnostics/ GeneOhm Sciences, Inc.
Coxiella burnetii   Joint Biological Agent Identification and Diagnostic System (JBAIDS) Q Fever Detection Kit   Idaho Technology, Inc.
Chlamydia trachomatis / Aptima Combo 2 Assay Hologic/Gen-Probe, Inc.  
 Neisseria gonorrhoeae    
  Xpert Ct/Ng Cepheid
  Aptima Combo 2 Assay (Panther System)   Gen-Probe, Inc.
  Cobas CT/NG Test   Roche Molecular Systems, Inc.
  Abbott RealTime CT/NG and Multi-Collect Specimen Collection Kit Abbott Molecular Inc.
  BD ProbeTec Chlamydia trachomatis (CT) Qx Amplified DNA Assay Becton, Dickinson, & Co.
  AMPLICOR CT/NG Test for Chlamydia trachomatis Roche Diagnostics Corp.
  Gen-Probe Aptima for Chlamydia Trochamatis Gen-Probe Aptima for Chlamydia Trochamatis Gen-Probe, Inc.  
  TIGRIS DTS Automated Analyzer Aptima Assay for Chlamydia trachomatis   Gen-Probe, Inc.  

 

TIGRIS DTS Gen-Probe Aptima Combo 2 Assay

Gen-Probe, Inc.

 

Cobas Amplicor CT/NG test for Chlamydia trachomatis

Roche Molecular Systems, Inc.

 

GEN-PROBE Aptima Combo 2 Assay  

Gen-Probe, Inc.

 

BDProbeTec ET Chlamydia trachomatis and Neisseria gonorrhoeae Amplified DNA Assays  

Becton, Dickinson, & Co.  

 

Roche Cobas AMPLICOR Chlamydia trachomatis test

Roche Molecular Systems, Inc.

 

Gen-Probe AMPLIFIED Chlamydia trachomatis Assay Kit

Gen-Probe, Inc.

 

LCX Chlamydia trachomatis Assay

Abbott Laboratories

 

BD Probetec Neisseria Gonorrhoeae (GC) Qx Amplified DNA Assay  

Becton, Dickinson, & Co.  

 

AMPLICOR CT/NG Test for Neisseria Gonorrhoeae

Roche Diagnostics Corp.  

 

Gen-Probe Aptima Assay for Neisseria Gonorrhoeae

Gen-Probe, Inc.

 

Tigris DTS Gen-Probe Aptima Assay for Neisseria  Gonorrhoeae

Gen-Probe, Inc.

 

COBAS Amplicor CT/NG test for Neisseria gonorrhoeae

Roche Molecular Systems, Inc.

 

Hybrid Capture II CT/GC DNA Test  

Digene Corp.

 

Roche AMPLICOR CT/NG test  for Neisseria gonorrhoeae

Roche Molecular Systems, Inc.

 

Digene GC-ID Test Hybrid Capture II Digene Corp.

 

Gen-Probe PACE 2C System Chlamydia Trachomatis / Neisseria gonorrhoeae  

Gen-Probe, Inc.

 

PACE2 Neisseria gonorrhoeae probe confirmation assay  

Gen-Probe, Inc.

 

GONOSTAT Gonococcal Detection Kit  

Sierra Diagnostics, Inc.

 

LCX Neisseria gonorrhoeae Assay Abbott Laboratories

Cytomegalovirus

 COBAS AmpliPrep/COBAS TaqMan CMV Test

Roche Molecular Systems  

 

NucliSens CMV pp67  

Organon Teknika Corporation  

Dengue virus  

CDC DENV-1-4 Real-Time RT-PCR Assay   Centers for Disease Control and Prevention  

Entercoccus  

IMDx Van R for Abbott m2000  

Intelligent Medical Devices, Inc.  

 

BD GeneOhm VanR Assay  

BD Diagnostics (GeneOhm Sciences, Inc.)  

 

Xpert vanA Assay  

Cepheid  

 

E. faecalis/OE PNA  

AdvanDx, Inc.

 

GBS PNA FISH  

AdvanDx, Inc.

 

E. faecalis PNA FISH culture identification kit  

AdvanDx, Inc.

Enterovirus  

NucliSens EasyQ Enterovirus vl.1 Assay   bioMérieux, Inc.  

Escherichia coli /  

GNR Traffic Light PNA FISH  

AdvanDx, Inc 

Klebsiella pneumoniae /  

 

 

Pseudomonas aeroginosa  

 

 

 

E. coli/P. aeruginosa PNA FISH   AdvanDx, Inc 

 

EK/P aeruginosa PNA FISH   AdvanDx, Inc 

 

E. coli PNA FISH  

AdvanDx, Inc.

Francisella tularensis  

JBAIDS Tularemia Detection Kit 

 

Gram-Positive /  

Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP)  

Nanosphere, Inc.  

Gram-Negative Bacteria

   

Herpes Simplex Virus  

IsoAmp HSV Assay 

BioHelix Corporation  

 

MultiCode-RTx Herpes Simplex Virus 1 & 2 Kit  

EraGen Biosciences, Inc.

 

BD ProbeTec Herpes Simplex Viruses (HSV I & 2) QX Amplified DNA Assays  

BD Diagnostic Systems  

Hepatitis virus  

Abbott RealTime HCV Genotype II  

Abbott Molecular, Inc.  

 

Abbott Realtime HCV Assay  

Abbott Molecular, Inc.  

 

Abbott Realtime HBV Assay  

Abbott Molecular, Inc.  

 

COBAS AmpliPrep/COBAS TaqMan HCV test  

Roche Molecular Systems  

 

COBAS Taqman HBV Test  

Roche Molecular Systems, Inc.  

 

Versant HCV 3.0 Assay (bDNA)  

Siemens Healthcare Diagnostics  

 

Versant HCV RNA Qualitative Assay  

Gen-Probe, Inc. .

 

COBAS AMPLICOR Hepatitis C Virus (HCV) Test  

Roche Molecular Systems, Inc

 

AMPLICOR HCV Test, v2.0   Roche Molecular Systems, Inc 

Human Metapneumovirus  

Quidel Molecular RSV + hMPV Assay  

Quidel Corporation  

 

Quidel Molecular hMPV Assay  

Quidel Corporation  

 

Pro hMPV+ Assay  

Prodesse, Inc.  

Human papillomavirus  

Aptima HPV Assay   Gen-Probe, Inc.  

 

COBAS HPV Test  

Roche Molecular Systems, Inc.  

 

Aptima HPV 16 18/45 Genptype Assay  

Gen-Probe, Inc.  

 

Cervista HPV 16/18   Hologic, Inc.  

 

Cervista HPV HR and Genfind DNA Extraction Kit  

Hologic, Inc.  

 

Digene Hybrid Capture 2 High-Risk HPV DNA Test  

Digene Corporation 

Influenza and Respiratory Viruses  

Prodesse ProFAST Assat  

Gen-Probe Prodesse, Inc.  

 

Quidel Molecular Influenza A + B Assay  

Quidel Corporation .

 

IMDx Flu A/B and RSV for Abbott m2000  

Intelligent Medical Devices, Inc.

 

CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel  

Centers for Disease Control and Prevention

 

Prodesse ProParaflu Assay   Gen-Probe Prodesse, Inc.  

 

Xpert Flu Assay

Cepheid  

 

Simplexa Flu A/B & RSV Direct

Focus Diagnostics, Inc.  

 

FilmArray Respiratory Panel (RP)

Idaho Technology, Inc.  

 

artus Infl A/B RG RT-PCR Kit Qiagen GmbH  

 

xTAG Respiratory Viral Panel (RVP) Luminex Molecular Diagnostics, Inc.  

 

JBAIDS Influenza A Subtyping Kit

U.S. Army Medical Materiel Development Activity

 

JBAIDS Influenza A&B Detection Kit  

U.S. Army Medical Materiel Development Activity  

 

eSensor Respiratory Viral Panel (RVP)  

GenMark Diagnostic  

 

Liat Influenza A/B Assay  

IQuum, Inc.  

 

ProFlu+ Assay  

Gen-Probe Prodesse, Inc.  

 

xTAG Respiratory Viral Panel Fast (RVP FAST)  

Luminex Molecular Diagnostics, Inc.  

 

Verigene Respiratory Virus Plus Nucleic Acid Test (RV+)  

Nanosphere, Inc.

 

Simplexa Flu A/B & RSV  

Focus Diagnostics, Inc.  

 

CDC Influenza 2009 A (H1N1) pdm Real-Time RT-PCR Panel  

Centers for Disease Control and Prevention  

 

JBAIDS Influenza A/H5 (Asian lineage) Detection Kit  

U.S. Army Medical Materiel Development Activity  

 

Simplexa Influenza A H1N1 (2009)

Focus Diagnostics, Inc. 

 

CDC Human Influenza Virus Real-time RT-PCR Detection and Characterization Panel  

Centers for Disease Control and Prevention  

 

Influenza A/H5 (Asian lineage) Virus Real-time RT-PCR Primer and Probe Set  

Centers for Disease Control and Prevention  

Leishmania species

 SMART Leish

U.S. Army Medical Materiel Development Activity

Mycobacterium tuberculosis  

Xpert MTB/RIF Assay  

Cepheid

 

BDProbetec ET Mycobacterium tuberculosis complex culture identification kit

Becton, Dickinson, & Co

 

Amplified Mycobacterium tuberculosis Direct Test Gen-Probe, Inc

 

Amplicor Mycobacterium tuberculosis test

Roche Molecular Systems, Inc.

 

SNAP M.tuberculosis complex

Syngene, Inc.

 

Accuprobe Mycobacterium tuberculosis complex Test

Gen-Probe, Inc.

 

Rapid Diagnostic System for Mycobacterium tuberculosis Gen-Probe, Inc.

 

Rapid Identification Test for Mycobacterium tuberculosis complex 

Gen-Probe, Inc.

Mycobacterium species 

Accuprobe Mycobacterium avium complex  Gen-Probe, Inc.

 

Accuprobe Mycobacterium kansasii Identification Test  

Gen-Probe, Inc.

 

SNAP Mycobacterium avium complex Syngene, Inc.  

 

Accuprobe Mycobacterium intracellulare Culture Identification Test

Gen-Probe, Inc.

 

Accuprobe Mycobacterium gordonae culture identification Test

Gen-Probe, Inc.

 

Rapid Diagnostic System for Mycobacterium gordonae

Gen-Probe, Inc.

 

Rapid Diagnostic System for Mycobacteria

Gen-Probe, Inc.

 

Rapid Identification Test for Mycobacterium avium

Gen-Probe, Inc.

 

Gen-Probe Mycobacterium Rapid Confirmation System

Gen-Probe, Inc.

Mycoplasma pneumoniae  

Illumigene Mycoplasma DNA Amplification Assay   Meridian Bioscience, Inc.  

Multiplex Panel  

ProGastro SSCS Assay  

Gen-Probe Prodesse, Inc.  

 

xTAG Gastrointestinal Pathogen Panel (GPP)  

Luminex Molecular Diagnostics, Inc.  

Staphylococcus  

BD Max MRSA Assay

BD Diagnostics (GeneOhm Sciences Canada, Inc.)  

 

Staphylococcus QuickFISH BC AdvanDx, Inc.

 

MRSA/SA ELITe MGB EliTechGroup Epoch Biosciences.

 

Verigene Staphylococcus Blood Culture (BC-S) Nucleic Acid Test

Nanosphere, Inc.

 

NucliSENS EasyQ MRSA Assay

bioMerieux, Inc.

 

Xpert MRSA/SA Blood Culture Assay

Cepheid

 

Xpert MRSA/SA Nasal Complete Assay

Cepheid

 

LightCycler MRSA Advanced Test

Roche Molecular Systems, Inc

 

BD GeneOhm MRSA ACP Assay

BD Diagnostics (GeneOhm Sciences Canada, Inc.)

 

S. aureus and/or other Staphylococcus species PNA FISH Culture

AdvanDx, Inc.

 

Xpert MRSA/SA SSTI Assay

Cepheid

 

BD GeneOhM StaphSR Assay  

BD Diagnostics (GeneOhm Sciences Canada, Inc.)

 

S. aureus PNA FISH

AdvanDx, Inc.

 

Xpert MRSA

Cepheid

 

IDI-MRSA Assay

Infectio Diagnostic, Inc.

Streptococci  

Xpert GBS LB Assay  

Cepheid  

 

illumigene Group A Streptococcus (GBS) DNA Amplification Assay

Meridian Bioscience, Inc. .

 

illumigene Group B Streptococcus (GBS) DNA Amplification Assay

 Meridian Bioscience, Inc.

 

BD Max GBS Assay

Becton, Dickinson, & Co.  

 

Cepheid Smart GBS Assay Cepheid 

 

Xpert GBS Cepheid 

 

IDI-Strep B Assay

Infectio Diagnostic, Inc.

 

Gen-Probe Accuprobe Group B Streptococcus culture identification kit

Chugai Pharmaceuticals Co, Ltd.  

 

Accuprobe Streptococcus pneumoniae culture confirmation  

Gen-Probe, Inc.  

Trichomonas vaginalis  

Aptima Trichomonas vaginalis assay  

Gen-Probe, Inc.  

 

Affirm/VP Identification Test G. Vaginalis and T. vaginalis  

Microprobe Corp.  

 

Xpert TV Assay  

Cepheid  

Yersinia pestis  

JBAIDS Plague Detection Kit  

Idaho Technology, Inc  

Related Policies
50108 Intravenous Antibiotic Therapy and Associated Diagnostic Testing for Lyme Disease

Policy 
The status of nucleic acid identification using direct probe, amplified probe, or quantification for the microorganism’s procedure codes is summarized in Table 1 below. "med nec" in the table below indicates that the test is considered MEDICALLY NECESSARY No PA Required; while “inv” tests indicates that the test is considered INVESTIGATIONAL.

Microorganism

Direct Probe

Amplified Probe

Quantification

Bartonella henselae or quintana

 

87471(med nec)                            

87472 (inv)

Chlamydia pneumoniae

87485 (inv)

87486 (inv)

87487 (inv)

Clostridium difficile

87493 (med nec)

 

 

Cytomegalovirus

87495 (med nec)

87496 (med nec)

87497 (med nec)

Enterococcus, Vancomycin-resistant (e.g., enterococcus vanA, vanB)

 

87500 (med nec)

 

Enterovirus

 

87498 (med nec)

 

Gastrointestinal Pathogen Panel

 

87505-87507 (med nec)

 

Hepatitis B

 

87516 (med nec)

87517 (med nec)

Hepatitis G

87525 (inv)

87526 (inv)

87527 (inv)

Herpes virus-6

87531 (med nec)

87532 (inv)

87533 (med nec)

HIV-1

87534 (med nec)

87535 (med nec)

87536 (med nec)

HIV-2

87537 (med nec)

87538 (med nec)

87539 (med nec)

Legionella pneumophila

87540 (med nec)

87541 (med nec)

87542 (inv)

Mycoplasma pneumoniae

87580 (med nec)

87581 (med nec)

87582 (inv)

Respiratory virus panel

 

87631-87633 (med nec)

 

Staphylococcus aureus

 

87640 (med nec) 

 

Staphylococcus aureus, methicillin resistant 

 

87641 (med nec) 

 

  1. PCR testing for Ebola is considered MEDICALLY NECESSARY and will currently be submitted with unspecified codes
  2. The technique for quantification includes both amplification and direct probes; therefore, simultaneous coding for both amplification or direct probes is considered NOT MEDICALLY NECESSARY
  3. PCR testing for the following microorganisms that do not have specific CPT codes is considered MEDICALLY NECESSARY (not an all-inclusive list):
    • Actinomyces, for identification of actinomyces species in tissue specimens
    • Adenovirus, to diagnose adenovirus myocarditis, and to diagnose adenovirus infection in immunocompromised hosts, including transplant recipients
    • Avian influenza A virus, for diagnosis of avian influenza A (H5N1) in persons with both: (i) symptoms consistent with Avian influenza A virus; and (ii) a history of travel to or contact with persons or birds from a country with documented H5N1 avian influenza infections within 10 days of symptom onset. 
    • Bacillus Anthracis
    • BK polyomavirus in transplant recipients receiving immunosuppressive therapies and persons with immunosuppressive diseases
    • Bordetella pertussis and B. parapertussis, for diagnosis of whooping cough in individuals with coughing
    • Brucella spp., for members with signs and symptoms of Brucellosis, and history of direct contact with infected animals and their carcasses or secretions or by ingesting unpasteurized milk or milk products
    • Burkholderia infections (including B. cepacia, B. gladioli), diagnosis
    • Chancroid (Haemophilus ducreyi), for diagnosis of persons with genital ulcer disease
    • Clostridium difficile, diagnosis
    • Coxiella burnetii, for confirmation of acute Q fever
    • Epidemic typhus (Rickettsia prowazekii), diagnosis
    • Epstein Barr Virus (EBV): for detection of EBV in post-transplant lymphoproliferative disorder; or for testing for EBV in persons with lymphoma; or for those who are immunocompromised for other reasons.
    • Francisella tularensis, for presumptive diagnosis of tularemia
    • Hantavirus, diagnosis
    • Hemorrhagic fevers and related syndromes caused by viruses of the family Bunyaviridae (Rift Valley fever, Crimean-Congo hemorrhagic fever, hemorrhagic fever with renal syndromes), for diagnosis in acute phase in persons with clinical presentation suggestive of these conditions
    • Hepatitis D virus, for confirmation of active infection in persons with anti-HDV antibodies
    • Hepatitis E virus, for definitive diagnosis in persons with anti-HEV antibodies
    • Human T Lymphotropic Virus type 1 and type 2 (HTLV-I and HTLV-II), to confirm the presence of HTLV-I and HTLV-II in the cerebrospinal fluid of persons with signs or symptoms of HTLV-I/HTLV-II
    • Human metapneumovirus
    • JC polyomavirus, in transplant recipients receiving immunosuppressive therapies, in persons with immunosuppressive diseases, and for diagnosing progressive multifocal leukoencephalopathy in persons with multiple sclerosis or Crohn's disease receiving natalizumab (Tysabri)
    • Leishmaniasis, diagnosis
    • Measles virus (Morbilliviruses), for diagnosis of measles
    • Mumps
    • Neisseria meningitidis, to establish diagnosis where antibiotics have been started before cultures have been obtained
    • Parvovirus, for detecting chronic infection in immunocompromised persons
    • Psittacosis, for diagnosis of Chlamydophila (Chlamydia) psittaci infection
    • Respiratory syncytial virus (RSV), for confirming the result of rapid antigen detection assay.
    • Rubella, diagnosis
    • Severe acute respiratory syndrome (SARS), for detection of SARS coronavirus RNA in persons with signs or symptoms of SARS who have traveled to endemic areas or have been exposed to persons with SARS
    • Toxoplasma gondii, for detection of T. gondii infection in immunocompromised persons with signs and symptoms of toxoplasmosis, and for detection of congenital Toxoplasmagondii infection (including testing of amniotic fluid for toxoplasma infection)
    • Varicella-Zoster infections
    •  Whipple's disease (T. whippeli), biopsy tissue from small bowel, abdominal or peripheral lymph nodes, or other organs of persons with signs and symptoms, to establish the diagnosis
    • Yersinia Pestis
  4. Quantitative PCR testing for the following indications is considered MEDICALLY NECESSARY:
    • Adenovirus viral load, to monitor response to antiviral therapy in infected immunocompromised hosts, including transplant recipients
    • BK polyomavirus viral load, for diagnosis and monitoring response to therapy in infected kidney transplant recipients
    • Cytomegalovirus (CMV) viral load, to monitor response to therapy
    • EBV viral load, to monitor for EBV viral replication in solid organ transplant recipients
    • Hepatitis B
    • Hepatitis C
    • Human herpesvirus type 6, to monitor response to therapy in immunocompromised hosts, including transplant recipients
    • HIV RNA viral load testing, to monitor disease progressionand response to therapy

Policy Guidelines
A discussion of every infectious agent that might be detected with a probe technique is beyond the scope of this policy. Many probes have been combined into panels of tests. For the purposes of this policy, other than the respiratory virus panel, only individual probes are reviewed.

Benefit Application
BlueCard/National Account Issues
Plans may wish to identify specific sites of service (i.e., hospital, reference laboratory, etc.).

References:

  1. Anderson NW, Buchan BW, Mayne D, et al. Multicenter clinical evaluation of the illumigene group A Streptococcus DNA amplification assay for detection of group A Streptococcus from pharyngeal swabs. J Clin Microbiol. May 2013;51(5):1474-1477. PMID 23447639
  2. Barron, E., Miller, M.,,,,Pritt, B. A Guide to Utilization of the Microbiology Laboratory for Diagnosis of Infectious Diseases: 2013 Recommendations by the Infectious Diseases Society of America (IDSA) and the American Society for Microbiology (ASM) a. Clin Infect Dis 2013; 57 (4): e22-e121. doi: 10.1093/cid/cit278
  3. Centers for Disease Control and Prevention (CDC). Diseases characterized by vaginal discharge. In: Sexually transmitted diseases treatment guidelines. MMWR. Dec 17;59(RR-12):56-63. 2010. http://www.cdc.gov/mmwr/PDF/rr/rr5912.pdf. Accessed August 25, 2014.
  4. Chu CJ, Hussain M, Lok AS. Quantitative serum HBV DNA levels during different stages of chronic hepatitis B infection. Hepatology. Dec 2002;36(6):1408-1415. PMID 12447866
  5. Felsenstein, S., Faddoul, D. , Sposto, R., Batoon, K., Polanco, CM, and, J.; Molecular and Clinical Diagnosis of Group A Streptococcal Pharyngitis in Children. J Clin Microbiol. 2014 Nov; 52(11): 3884–3889
  6. Khan AS (2014) Rapid Advances in Nucleic Acid Technologies for Detection and Diagnostics of Pathogens. J Microbiol Exp 1(2): 00009. DOI: 10.15406/jmen.2014.01.00009
  7. Kiraz N1, Saglik I, Kiremitci A, Kasifoglu N, Akgun Y, Evaluation of the GenoType Mycobacteria Direct assay for direct detection of the Mycobacterium tuberculosis complex obtained from sputum samples. J Med Microbiol. 2010 Aug;59(Pt 8):930-4. doi: 10.1099/jmm.0.013490-0. Epub 2010 May
  8. Li H, Dummer JS, Estes WR, et al. Measurement of human cytomegalovirus loads by quantitative real-time PCR for monitoring clinical intervention in transplant recipients. J Clin Microbiol. Jan 2003;41(1):187-191. PMID 12517846
  9. Mothershed, E., and Whitney, A. (2005). Nucleic acid-based methods for the detection of bacterial pathogens: Present and future considerations for the clinical laboratory. Retrieved April 21, 2017, from http://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.468.2821&rep=rep1&type=pdf 

Coding

Microorganism

Direct Probe

Amplified Probe

Quantification

Bartonella henselae or quintana

87470 (med nec)

87471(med nec)                            

87472 (inv)

Chlamydia pneumoniae

87485 (inv)

87486 (inv)

87487 (inv)

Clostridium difficile

87493 (med nec)

 

 

Cytomegalovirus

87495 (med nec)

87496 (med nec)

87497 (med nec)

Enterococcus, Vancomycin-resistant (e.g., enterococcus vanA, vanB)

 

87500 (med nec)

 

Enterovirus

 

87498 (med nec)

 

Gastrointestinal Pathogen Panel

 

87505-87507 (med nec)

 

Hepatitis B

 

87516 (med nec)

87517 (med nec)

Hepatitis G

87525 (inv)

87526 (inv)

87527 (inv)

Herpes virus-6

87531 (med nec)

87532 (inv)

87533 (med nec)

HIV-1

87534 (med nec)

87535 (med nec)

87536 (med nec)

HIV-2

87537 (med nec)

87538 (med nec)

87539 (med nec)

Legionella pneumophila

87540 (med nec)

87541 (med nec)

87542 (inv)

Mycoplasma pneumoniae

87580 (med nec)

87581 (med nec)

87582 (inv)

Respiratory virus panel

 

87631-87633 (med nec)

 

Staphylococcus aureus

 

87640 (med nec) 

 

Staphylococcus aureus, methicillin resistant 

 

87641 (med nec) 

 

Hepatitis B screening in non-pregnant, high risk individual includes hepatitis B surface antigen (HBsAg) followed by a neutralizing confirmatory test for initially reactive results, and antibodies to HBsAg (anti-HBs) and hepatitis B core antigen (anti-HBc) is considered MEDICALLY NECESSARY . 

G0499 (med nec)

 

 

Infectious agent detection by nucleic acid (DNA or RNA), human papillomavirus (HPV) for five or more separately reported high-risk HPV types (eg, 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68) (ie, genotyping) 

0500T 

 

 

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     

09/25/2019 

Corrected formatting. No other changes made. 

05/29/2019 

Corrected Typo. No change to policy intent. 

11/27/2018 

Major rewrite of this policy related to adoption of diagnostic testing of most common sexually transmitted infections, B-Hemolytic Streptococcus Testing, and testing for mosquito or tick-related infections. All four policies will be implemented on 02/01/2019. 

12/7/2017 

Updating policy with 2018 coding. No other changes. 

11/28/2017 

Annual review. Updating background, description, reg status, policy, guidelines, references and coding.

04/25/2017 

Updated category to Laboratory. No other changes. 

01/10/2017 

Annual Review. No significant changes.

11/30/2016 

Updated coding section with 2017 codes. 

05/09/2016 

Interim review, updating Human herpes virus 6 testing to indicate that direct probe and quantification can be considered medically necessary, but, that amplified probe (87532) is considered investigational. No other changes. 

01/21/2015 

Returning Borrelia burgdorferi as medically necessary with reference to see policy 50108. 

01/05/2016 

Interim review with the following policy intent changes: Medically necessary statement added for non-quantified nucleic acid-based testing for enterovirus, Legionella pneumophila, Mycoplasma pneumoniae, and Bartonella spp, and for quantified testing for human herpesvirus 6. Borrelia, major revision in the visual look of the policy, but, only the content listed has been altered in intent. Updating background, description, guidelines, verbiage, rationale and references, and coding. 

11/24/2015 

Annual review, no changes made. 

3/16/2015 

Removed the word "archived" in table 1 on Candida species, Gardnerella vaginalis and  Human Papillomavirus lines. No other changes.

10/27/2014

Annual review. Added description and coding. Updated background, policy, rationale and references. New CPT codes(8751xx 1-3 and 876xx 3-5 added.


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