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HumanaCommercial Clinical Policy

Humana Multiplex Pathogen Identification Panels for Infectious Disease Form


Central Nervous System Infection Multiplex Pathogen Identification Panel

Indications

(630283) Does the patient present with signs and symptoms of CNS infection such as encephalitis or meningitis? 

Gastrointestinal Multiplex Pathogen Identification Panel – Targeted (Up to 5 Targets)

Indications

(630284) Does the patient present with signs and symptoms of gastrointestinal infection including travel-related diarrhea for greater than 7 days duration? 
(630285) Are traditional stool test results such as culture, microscopic analysis, antigen analysis negative? 
(630286) Will the results of the test determine therapeutic management such as antibiotic treatment? 

Gastrointestinal Infection Multiplex Pathogen Identification Panel – Expanded (6 to 25 Targets)

Indications

(630287) Does the patient meet the above criteria for targeted panel? 

YesNoN/A
YesNoN/A
YesNoN/A

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Effective Date

12/14/2023

Last Reviewed

NA

Original Document

  Reference



Description

Microbes (eg, bacteria, fungi, parasites, viruses) cause infections in humans. Testing methods for detecting microbes traditionally include detection by cultures or antibody testing. However, since microbes contain genetic material (DNA and RNA), genetic testing methods can be applied to detect pathogens. The genetic material in microbes differs from the genetic material in human cells. Samples used for genetic testing for infectious disease include aspirated fluid around joints, blood, cerebrospinal fluid, sputum, stool, and urine. Genetic testing can be used to diagnose infections, identify and type the microbes causing an infection as well as determine if a microbe will respond to a specific treatment.

Multiplex Pathogen Identification Panels for Infectious Disease

Effective Date: 12/14/2023
Revision Date: 12/14/2023
Review Date: 12/14/2023
Policy Number: HUM-0578-018

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Nucleic acid amplification test (NAAT or NAT) is one type of genetic test used for infectious disease. This technique makes numerous copies (amplification) of any genetic material from the microbes present in a sample so that it can be more easily detected. One type of NAAT is polymerase chain reaction (PCR). These tests provide faster results than traditional methods and are more sensitive and specific.

Some newer genetic tests for infectious disease can analyze for several different microbes simultaneously from a single sample. This is called panel testing, also known as molecular panels or multiplex testing. Panel tests may be used to identify infections that have similar signs and symptoms but can be caused by a variety of microbes. Currently, the most common panel tests are respiratory or gastrointestinal infection multiplex NAAT panels. For example, an individual may present with symptoms such as abdominal pain and diarrhea which can be caused by a virus, bacteria or parasite. Genetic testing panels may lead to a quicker diagnosis which can influence treatment decisions but may also include those with unclear medical management. Another indication for multiplex pathogen identification testing are central nervous system (CNS) infections. BioFire FilmArray Meningitis/Encephalitis (ME) Panel is an example of multiplex pathogen test for CNS infections.

Multiplex pathogen identification panels have been suggested for the evaluation of many types of infections including, but may not be limited to, bloodstream, bone and joint, encephalitis, meningitis, surgical wounds and urinary tract infections. Examples of multiplex pathogen identification panels for these infections include, but may not be limited to:

  • Accelerate PhenoTest BC Kit
  • BioFire Bone and Joint Infection (BJI) Panel
  • BioFire FilmArray Blood Culture Identification (BCID2) Panel
  • Lesion Infection (Wound)
  • Qlear UTI
  • Qlear UTI-Reflex ABR
  • Urogenital Pathogen with Rx Panel (UPX)

Next-generation sequencing (NGS), also known as high-throughput sequencing or deep sequencing, has been proposed to identify microbial infections for several indications. There are two approaches to NGS: whole genome sequencing or targeted sequencing which includes PCR in the process.

An example of NGS for infectious disease includes MicroGenDx qPCR and NGS for Infection. (Refer to Coverage Limitations section).

Antibiotic resistance testing, also known as antimicrobial susceptibility testing, provides information that can be used to guide treatment decisions such as the selection of appropriate antibiotic regimens. There are different methods for testing, including conventional methods (phenotypic testing) and newer molecular (genotypic) techniques such as PCR, NAAT and NGS. Examples of molecular antibiotic resistance tests include, but may not be limited to, ABRx Antibiotic Resistance Panel, RevoGene Carba C and XPERT CARBA-R. (Refer to Coverage Limitations Section).

Some laboratories offer panels that include both pathogen identification and antibiotic resistance or sensitivity. Panels are used for many indications including, but may not be limited to, recurrent urinary tract infections (UTIs). Examples of this type of testing include, but may not be limited to, GENETWORx UTI with ABR, Guidance UTI and Qlear UTI-Reflex ABR. (Refer to Coverage Limitations section).

Differentiation between bacterial from viral infections is an emerging indication for multiplex pathogen testing. An example of this type of test is MeMed BV. (Refer to Coverage Limitations section).

Metagenomic NGS is an evolving, novel molecular technology proposed to detect pathogens for infectious disease and can potentially provide direct, unbiased analysis of microbial composition of specimens without reliance on traditional culture or targeted molecular tests. An example is Johns Hopkins Metagenomic Next-Generation Sequencing Assay for Infectious Disease. (Refer to Coverage Limitations section).

Genetic testing for infectious disease differs from genetic tests for inherited conditions. Microbes associated with infectious disease contain genetic material but the genetic material contained within microbes differs from genetic material within human cells. Genetic testing for inherited conditions, also known as germline mutation testing, analyzes an individual’s DNA and can identify genetic mutations to determine inherited risk of disease. An individual’s germline DNA is constant and identical in all body tissue types. The DNA and RNA of microbes are present only in infected tissues or fluids.

Multiplex Pathogen Identification Panels for Infectious Disease Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 12/14/2023 Policy Number: HUM-0578-018 Page: 4 of 35

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. The tissue sampled, are not representative of an individual’s germline DNA and are not inheritable.

Related Medical Coverage Policies

  • Test/Indication: Molecular testing for bacterial
    Medical Coverage Policy: Molecular Diagnostic Testing for
  • Test/Indication: Viral testing for SARS-CoV-2
    Medical Coverage Policy: Severe Acute Respiratory Syndrome
Coverage Determination
Central Nervous System Infection Multiplex Pathogen Identification Panel

Humana members may be eligible under the Plan for central nervous system (CNS) infection multiplex pathogen identification panel (87483) when an individual presents with signs and symptoms of CNS infection (eg, encephalitis, meningitis).

Gastrointestinal Multiplex Pathogen Identification Panel – Targeted (Up to 5 Targets)

Humana members may be eligible under the Plan for gastrointestinal multiplex pathogen identification panel up to 5 targets (87505) when the following criteria are met:

  • Individual presents with signs and symptoms of gastrointestinal infection including travel-related diarrhea (eg, abdominal pain, bloody stool, dehydration, diarrhea, loss of appetite, nausea, vomiting) for greater than 7 days duration; AND
  • Traditional stool test (eg, culture, microscopic analysis, antigen analysis) results are negative; AND
  • Results of the test will determine therapeutic management (eg, antibiotic treatment)

Gastrointestinal Infection Multiplex Pathogen Identification Panel – Expanded (6 to 25 Targets)

Humana members may be eligible under the Plan for gastrointestinal infection multiplex pathogen identification panel containing 6 to 25 targets (87506, 87507) when the following criteria are met:

  • Individual meets the above criteria for targeted panel; AND
  • Individual is immunocompromised and/or considered high-risk for serious complications and includes any of the following:
    • Currently receiving cancer treatment; OR
    • Currently receiving chronic glucocorticoid therapy; OR
    • Diagnosed with human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS); OR
    • Diagnosed with inherited disease that affects the immune system (eg, agammaglobulinemia, selective IgA deficiency); OR
    • Organ transplant recipient

Respiratory Infection Multiplex Pathogen Identification Panel – Targeted (Up to 5 Targets)

Humana members may be eligible under the Plan for respiratory infection multiplex pathogen identification panel up to 5 targets (87631) when the following criteria are met:

  • Individual presents with signs and symptoms of respiratory infection (eg, cough, dyspnea [short of breath], fever, sore throat, tight chest, wheezing); AND

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

  • Individual is immunocompromised and/or considered high-risk for serious complications and includes any of the following:
    • Currently receiving cancer treatment; OR
    • Currently receiving chronic glucocorticoid therapy; OR
    • Diagnosed with human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS); OR
    • Diagnosed with inherited disease that affects the immune system (eg, agammaglobulinemia, selective IgA deficiency); OR
    • Organ transplant recipient; AND
  • Results of the test will determine therapeutic management (eg, antibiotic treatment)

Coverage Limitations

Humana members may NOT be eligible under the Plan for multiplex pathogen identification panels for infectious disease for any indications other than those listed above including, but may not be limited to:

  • Antibiotic resistance including, but may not be limited to:
    • ABRx Antibiotic Resistance Panel
    • Acuitas AMR Gene Panel
    • RevoGene Carba C
    • XPERT Carba-R
  • Aspergillus species (eg, MycoDART Dual Amplification Real-Time PCR Panel for 4 Aspergillus Species [Aspergillus Diagnostic Panel] [0109U])
  • Bacteremia
  • Blood culture identification (87154) including, but may not be limited to:
    • BioFire FilmArray Blood Culture Identification 2 (BCID2) Panel
    • ePlex BCID Gram-Positive Panel (0141U)
    • ePlex BCID Gram-Negative Panel (0142U)
  • Candidiasis, including nails (eg, Candida Comprehensive Panel, T2Candida Panel) (87481)
  • Combination pathogen identification and antibiotic resistance or sensitivity
  • Differentiation of bacterial from viral infection (eg, MeMed BV [0351U])
  • Ear, nose and throat (ENT) (eg, Bacterial ENT Test Panel, Fungal ENT Test Panel, GENETWORx ENT Pathogen Panel, Viral ENT Test Panel)
  • Eye infection (eg, Bacterial Eye Infection Test Panel, Fungal Eye Infection Test, Panel Viral Eye Infection Test Panel)
  • Fever of unknown origin/acute febrile illness (eg, BioFire Global Fever Panel, BioFire Global Fever Special Pathogens Panel)
  • Fungal pathogen identification (eg, ePlex BCID Fungal Pathogens [FP] Panel [0140U])
  • Hematuria
  • Interstitial cystitis (bladder pain syndrome)
  • Myalgia
  • Onychomycosis, including dystrophic nails (eg, Nail Fungal Infection Test, Nail PCR Diagnostics)
  • Osteomyelitis (including bone and joint infections) (eg, BioFire Joint Infection [JI] Panel)
  • Pancreatitis
  • Pneumonia (eg, BioFire FilmArray Pneumonia Plus Panel)

Multiplex Pathogen Identification Panels for Infectious Disease Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 12/14/2023 Policy Number: HUM-0578-018 Page: 7 of 35

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Multiplex Pathogen Identification Panels for Infectious Disease Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 12/14/2023 Policy Number: HUM-0578-018 Page: 8 of 35

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

  • Prostatitis (eg, Guidance Prostatitis)
  • Prosthetic joint infection
  • Pyelonephritis
  • Sepsis (eg, T2Bacteria Panel)
  • Tinea pedis
  • Urinary tract infection (UTI) including, but may not be limited to:
    • Bridge Urinary Tract Infection Detection and Resistance Test (0321U)
    • GENETWORx Molecular PCR UTI Test (0416U)
    • Guidance UTI
    • Qlear UTI (0371U)
    • Qlear UTI-Reflex ABR (0372U)
    • Urogenital Pathogen with Rx Panel (UPX) (0374U)
  • Venous leg ulcer
  • Wound infection (eg, GENETWORx Wound Infection Diagnostics, Lesion Infection [Wound] [0370U], Wound Pathogen Panel)

These are considered experimental/investigational as they are not identified as widely used and generally accepted for any other proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Humana members may NOT be eligible under the Plan for the following tests:

  • Metagenomic sequencing including, but may not be limited to:
    • Johns Hopkins Metagenomic Next-Generation Sequencing Assay for Infectious Disease (0323U)
    • Karius Test (0152U)

Multiplex Pathogen Identification Panels for Infectious Disease Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 12/14/2023 Policy Number: HUM-0578-018 Page: 9 of 35

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

  • MicroGenDx qPCR & NGS for Infection (0112U)

RNA fluorescence in situ hybridization (FISH) with phenotypic minimum inhibitory concentration (MIC)-based antimicrobial susceptibility including, but may not be limited to:

  • Accelerate PhenoTest BC Kit (0086U)
  • Accelerate PhenoTest BC Kit AST Configuration (0311U)

These are considered experimental/investigational as they are not identified as widely used and generally accepted for the proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Humana members may NOT be eligible under the plan for multiplex pathogen identification panels for infectious disease for any of the following:

  • Duplicative testing following treatment for clearance of pathogen
  • Duplicative testing within an episode for the same diagnosis
  • Gastrointestinal panels of 26 or more targets (eg, GI Assay [Gastrointestinal Pathogen with ABR] [0369U])
  • Multiplex pathogen identification panel for respiratory infections performed simultaneously with multiplex pathogen identification panel for pneumonia
  • Respiratory panels 6 or more targets (87632, 87633) including, but may not be limited to:
    • BioFire FilmArray Respiratory Panel [RP]
    • BioFire Respiratory Panel 2.1 [0202U]
    • BioFire SpotFire Respiratory (R) Panel
    • ePlex Respiratory Pathogen (RP) Panel [0115U]
    • ePlex Respiratory Pathogen Panel 2 [RP2] [0225U]
    • NxTAG Respiratory Pathogen Panel
    • NxTAG Respiratory Pathogen Panel + SARS-CoV-2
    • QIAstat-Dx Respiratory SARS-CoV-2 Panel [0223U]
  • Respiratory Pathogen with ABR (RPX) (0373U)
  • T.E.N. Upper Respiratory Infection Panel

These are considered not medically necessary as defined in the member’s individual certificate.

Multiplex Pathogen Identification Panels for Infectious Disease Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 12/14/2023 Policy Number: HUM-0578-018 Page: 10 of 35

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Please refer to the member’s individual certificate for the specific definition.

Additional information about infectious disease may be found from the following websites:

  • BackgroundCenters for Disease Control and Prevention
  • Infectious Diseases Society of America
  • National Library of Medicine

Medical Alternatives

Alternatives to multiplex pathogen identification panel for bacteremia include, but may not be limited to:

  • Blood culture

Alternatives to multiplex pathogen identification panel for chronic wounds include, but may not be limited to:

  • Cultures/pathology of wound, urine and blood

Alternatives to multiplex pathogen identification panel for onychomycosis include, but may not be limited to:

  • Fungal culture
  • Histopathologic examination of nail clippings

Alternatives to multiplex pathogen identification panel for prostatitis include, but may not be limited to:

  • Urinalysis and culture

Multiplex Pathogen Identification Panels for Infectious Disease Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 12/14/2023 Policy Number: HUM-0578-018 Page: 11 of 35

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Alternatives to multiplex pathogen identification panel for sinusitis and rhinosinusitis include, but may not be limited to:

  • Clinical examination
  • Nasal/sinus cultures

Alternatives to multiplex pathogen identification panel for tinea pedis include, but may not be limited to:

  • Clinical examination
  • Microscopy and culture of skin scrapings

Alternatives to multiplex pathogen identification panel for urinary tract infection include, but may not be limited to:

  • Urinalysis and culture

Physician consultation is advised to make an informed decision based on an individual’s health needs.

Any CPT, HCPCS or ICD codes listed on this medical coverage policy are for informational purposes only. Do not rely on the accuracy and inclusion of specific codes. Inclusion of a code does not guarantee coverage and or reimbursement for a service or procedure.