CurrentBlue Cross Blue Shield - TennesseePolicy N/A

Identification of Microorganisms using Nucleic Acid Probes

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This reimbursement policy describes coverage determinations for nucleic acid probe and amplification-based testing to identify microorganisms, and specifies which CPT-coded probe/amplification/quantification tests meet or do not meet coverage criteria. It applies to Blue Cross Blue Shield - Tennessee members (see applicable states).

Policy Summary

PayerBlue Cross Blue Shield - Tennessee

PolicyIdentification of Microorganisms using Nucleic Acid Probes

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJul 1, 2023

Next Review DateN/A

Key ActionDo not order direct probe, amplified probe, and/or quantification simultaneously for the same organism in a single encounter; such combinations do not meet coverage criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

multipleCPT entries provided

prohibitedSimultaneous ordering

coveredPCR for unspecified organisms

CDC/WHO/IDSAExternal references cited

7/1/2023Policy effective

Coverage Determinations and Clinical Recommendations

Organism-specific coverage matrix

Coverage determinations are provided by organism and by procedure type (direct probe, amplified probe, quantification). 'MCC' indicates meets coverage criteria; 'DNMCC' indicates does not meet coverage criteria. Simultaneous ordering of any combination of direct probe, amplified probe, and/or quantification for the same organism in a single encounter does not meet coverage criteria. For organisms without a specific CPT code, PCR testing meets coverage criteria.

ALL of the following

Amplified Probe = 87471 (MCC)
Quantification = 87472 (DNMCC)

ALL of the following

Direct Probe = 87480 (MCC); (87480 is DNMCC for non-vaginitis situations — see AHS-M2057)
Amplified Probe = 87481 (DNMCC)
Quantification = 87482 (DNMCC)

ALL of the following

Direct Probe = 87485 (MCC)
Amplified Probe = 87486 (MCC)
Quantification = 87487 (DNMCC)

ALL of the following

Direct Probe = 87493 (MCC)

ALL of the following

Direct Probe = 87495 (MCC)
Amplified Probe = 87496 (MCC)
Quantification = 87497 (MCC)

ALL of the following

Amplified Probe = 87500 (MCC)

ALL of the following

Amplified Probe = 87498 (MCC)

ALL of the following

Amplified Probe = 87516 (MCC)
Quantification = 87517 (MCC)

ALL of the following

Direct Probe = 87525 (DNMCC)
Amplified Probe = 87526 (DNMCC)
Quantification = 87527 (DNMCC)

ALL of the following

Direct Probe = 87531 (MCC)
Amplified Probe = 87532 (DNMCC)
Quantification = 87533 (MCC)

ALL of the following

Direct Probe = 87540 (MCC)
Amplified Probe = 87541 (MCC)
Quantification = 87542 (DNMCC)

ALL of the following

Amplified Probe = 87593 (MCC)

ALL of the following

Direct Probe = 87580 (MCC)
Amplified Probe = 87581 (MCC)
Quantification = 87582 (DNMCC)

ALL of the following

Amplified Probe = 87563 (MCC)

ALL of the following

Amplified Probe = 87634 (MCC)

ALL of the following

Amplified Probe = 87640 (MCC)
Methicillin-resistant S. aureus, Amplified Probe = 87641 (MCC)

Coverage-related guidance and clinical testing recommendations

Guidance and testing recommendations from cited public health authorities relevant to diagnostic testing and when testing is advised:

ALL of the following

Test men with recurrent nongonococcal urethritis using an FDA-cleared NAAT; perform resistance testing if available and use results to guide therapy.
Test women with recurrent cervicitis and consider testing in pelvic inflammatory disease (PID); do not screen asymptomatic persons or perform routine extragenital testing.

ALL of the following

Use rRT-PCR (highly sensitive) when testing older children and adults with suspected RSV.
Antigen detection and rRT-PCR are effective diagnostic tests in infants and young children.

ALL of the following

Recommend testing probable cases with a monkeypox-specific PCR or an orthopoxvirus PCR assay confirmed by sequencing (ECDC).
Diagnose monkeypox with PCR on a viral swab taken from one or more vesicles or ulcers (UKHSA).
Advise persons with compatible rash and systemic symptoms to seek testing (ECDC/WHO joint advice).

ALL of the following

Diagnosis requires detection of Salmonella through culture or a culture-independent diagnostic test (CIDT).

ALL of the following

NAATs can detect mecA, the most common gene mediating methicillin resistance, but will not detect novel resistance mechanisms or uncommon phenotypes.

CPT Codes and Coding Rules

CPT probe/amplification/quantification codesCPT

87471	Bartonella henselae or quintana, Amplified Probe (MCC)
87472	Bartonella henselae or quintana, Quantification (DNMCC)
87480	Candida species, Direct Probe — MCC for vaginitis; DNMCC for other situations
87481	Candida species, Amplified Probe (DNMCC)
87482	Candida species, Quantification (DNMCC)
87485	Chlamydia pneumoniae, Direct Probe (MCC)
87486	Chlamydia pneumoniae, Amplified Probe (MCC)
87487	Chlamydia pneumoniae, Quantification (DNMCC)
87493	Clostridium difficile, Direct Probe (MCC)
87495	Cytomegalovirus, Direct Probe (MCC)

1–10 of 33

1/4

Simultaneous ordering restrictionCPT

Simultaneous ordering of direct probe, amplified probe, and/or quantification for the same organism in a single encounter does not meet coverage criteria (prohibited).

Simultaneous ordering prohibition

Policy prohibitionSimultaneous ordering of any combination of direct probe, amplified probe, and/or quantification for the same organism in a single encounter does not meet coverage criteria.

ScopeApplies when multiple procedure types (direct probe, amplified probe, quantification) are ordered for the same organism during one clinical encounter.

Implication for billingClaims for concurrent tests of different procedure types for the same organism may be denied as not meeting coverage criteria.

Related guidanceSee organism-specific CPT matrix for which single procedure type meets coverage criteria (MCC vs DNMCC).

Provider Billing Rules and Actionable Notes

Denial Risk

Simultaneous testing for same organism not covered

Simultaneous ordering of any combination of direct probe, amplified probe, and/or quantification for the same organism in a single encounter does not meet coverage criteria.

Prior Authorization

PCR covered for organisms without a specific CPT code

For any microorganism without a specific CPT code, PCR testing meets coverage criteria.

Documentation Required

LDT validation and CLIA regulation

Laboratory-developed tests (LDTs) must be validated and performed in-house and are regulated by CMS as high-complexity tests under CLIA; FDA clearance or approval is not required for clinical use.

Terminology and Test Definitions

Nucleic acid hybridization / PCR (brief)

DefinitionNucleic acid hybridization technologies use complementary properties of DNA double-helix structures to anneal DNA fragments from different sources for identification of microorganisms.

Techniques includedIncludes polymerase chain reaction (PCR), ligase- or helicase-dependent amplification, transcription-mediated amplification, and related hybridization/FRET approaches used for pathogen detection.

Clinical utilityThese methods offer increased sensitivity and specificity, reduced time to result, and high-throughput capability compared with traditional microbiology.

LimitationsPotential limitations include contamination risk, lack of standardization/validation for some assays, complex interpretation, and increased cost.

Terminology (short definitions)

PCRPolymerase chain reaction; a nucleic acid amplification method to replicate DNA sequences.

qPCRQuantitative polymerase chain reaction; PCR variant that measures DNA quantity in real time.

NAATsNucleic acid amplification tests; molecular assays (e.g., PCR) for detecting pathogen nucleic acid.

FRETFluorescent resonance energy transfer; a technique used in some hybridization-based detection assays.

rRT-PCRReal-time reverse transcriptase–PCR; used for RNA viruses and reported as a terminology entry in the policy.

Laboratory-developed test (LDT)

DefinitionLaboratory-developed test (LDT): a test developed and validated by a laboratory for in-house use.

Regulatory statusLDTs are regulated by CMS as high-complexity tests under CLIA '88.

FDA clearanceLDTs are not approved or cleared by the U.S. Food and Drug Administration; FDA clearance/approval is not currently required for clinical use.

Validation requirementLabs that develop LDTs must validate and perform those tests in-house per the policy statement.

NAAT / PCR and resistance gene detection

CapabilityNAATs (such as PCR) can be used for direct detection of resistance genes (example: mecA for methicillin resistance in Staphylococcus aureus).

LimitationNAATs will not detect novel resistance mechanisms or uncommon phenotypes not targeted by the assay.

Clinical noteDetection of known resistance genes by NAATs can inform management but does not replace phenotypic susceptibility testing when needed.

Policy Summary

PayerBlue Cross Blue Shield - Tennessee

PolicyIdentification of Microorganisms using Nucleic Acid Probes

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJul 1, 2023

Next Review DateN/A

Key ActionDo not order direct probe, amplified probe, and/or quantification simultaneously for the same organism in a single encounter; such combinations do not meet coverage criteria.

SourceLink

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Identification of Microorganisms using Nucleic Acid Probes

Customize your policy alerts

Sign up for all blue cross blue shield - tennessee policy alerts

Know when blue cross blue shield - tennessee releases new policies or updates existing guidance.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Coverage Determinations and Clinical Recommendations

Organism-specific coverage matrix

ALL of the following

Amplified Probe = 87471 (MCC)
Quantification = 87472 (DNMCC)

ALL of the following

Direct Probe = 87480 (MCC); (87480 is DNMCC for non-vaginitis situations — see AHS-M2057)
Amplified Probe = 87481 (DNMCC)
Quantification = 87482 (DNMCC)

ALL of the following

Direct Probe = 87485 (MCC)
Amplified Probe = 87486 (MCC)
Quantification = 87487 (DNMCC)

ALL of the following

Direct Probe = 87493 (MCC)

ALL of the following

Direct Probe = 87495 (MCC)
Amplified Probe = 87496 (MCC)
Quantification = 87497 (MCC)

ALL of the following

Amplified Probe = 87500 (MCC)

ALL of the following

Amplified Probe = 87498 (MCC)

ALL of the following

Amplified Probe = 87516 (MCC)
Quantification = 87517 (MCC)

ALL of the following

Direct Probe = 87525 (DNMCC)
Amplified Probe = 87526 (DNMCC)
Quantification = 87527 (DNMCC)

ALL of the following

Direct Probe = 87531 (MCC)
Amplified Probe = 87532 (DNMCC)
Quantification = 87533 (MCC)

ALL of the following

Direct Probe = 87540 (MCC)
Amplified Probe = 87541 (MCC)
Quantification = 87542 (DNMCC)

ALL of the following

Amplified Probe = 87593 (MCC)

ALL of the following

Direct Probe = 87580 (MCC)
Amplified Probe = 87581 (MCC)
Quantification = 87582 (DNMCC)

ALL of the following

Amplified Probe = 87563 (MCC)

ALL of the following

Amplified Probe = 87634 (MCC)

ALL of the following

Amplified Probe = 87640 (MCC)
Methicillin-resistant S. aureus, Amplified Probe = 87641 (MCC)

Coverage-related guidance and clinical testing recommendations

Guidance and testing recommendations from cited public health authorities relevant to diagnostic testing and when testing is advised:

ALL of the following

Test men with recurrent nongonococcal urethritis using an FDA-cleared NAAT; perform resistance testing if available and use results to guide therapy.
Test women with recurrent cervicitis and consider testing in pelvic inflammatory disease (PID); do not screen asymptomatic persons or perform routine extragenital testing.

ALL of the following

Use rRT-PCR (highly sensitive) when testing older children and adults with suspected RSV.
Antigen detection and rRT-PCR are effective diagnostic tests in infants and young children.

ALL of the following

Recommend testing probable cases with a monkeypox-specific PCR or an orthopoxvirus PCR assay confirmed by sequencing (ECDC).
Diagnose monkeypox with PCR on a viral swab taken from one or more vesicles or ulcers (UKHSA).
Advise persons with compatible rash and systemic symptoms to seek testing (ECDC/WHO joint advice).

ALL of the following

Diagnosis requires detection of Salmonella through culture or a culture-independent diagnostic test (CIDT).

ALL of the following

NAATs can detect mecA, the most common gene mediating methicillin resistance, but will not detect novel resistance mechanisms or uncommon phenotypes.

CPT Codes and Coding Rules

CPT probe/amplification/quantification codesCPT

87471	Bartonella henselae or quintana, Amplified Probe (MCC)
87472	Bartonella henselae or quintana, Quantification (DNMCC)
87480	Candida species, Direct Probe — MCC for vaginitis; DNMCC for other situations
87481	Candida species, Amplified Probe (DNMCC)
87482	Candida species, Quantification (DNMCC)
87485	Chlamydia pneumoniae, Direct Probe (MCC)
87486	Chlamydia pneumoniae, Amplified Probe (MCC)
87487	Chlamydia pneumoniae, Quantification (DNMCC)
87493	Clostridium difficile, Direct Probe (MCC)
87495	Cytomegalovirus, Direct Probe (MCC)

1–10 of 33

1/4

Simultaneous ordering restrictionCPT

Simultaneous ordering of direct probe, amplified probe, and/or quantification for the same organism in a single encounter does not meet coverage criteria (prohibited).

Simultaneous ordering prohibition

Policy prohibitionSimultaneous ordering of any combination of direct probe, amplified probe, and/or quantification for the same organism in a single encounter does not meet coverage criteria.

ScopeApplies when multiple procedure types (direct probe, amplified probe, quantification) are ordered for the same organism during one clinical encounter.

Implication for billingClaims for concurrent tests of different procedure types for the same organism may be denied as not meeting coverage criteria.

Related guidanceSee organism-specific CPT matrix for which single procedure type meets coverage criteria (MCC vs DNMCC).

Provider Billing Rules and Actionable Notes

Denial Risk

Simultaneous testing for same organism not covered

Simultaneous ordering of any combination of direct probe, amplified probe, and/or quantification for the same organism in a single encounter does not meet coverage criteria.

Prior Authorization

PCR covered for organisms without a specific CPT code

For any microorganism without a specific CPT code, PCR testing meets coverage criteria.

Documentation Required

LDT validation and CLIA regulation

Laboratory-developed tests (LDTs) must be validated and performed in-house and are regulated by CMS as high-complexity tests under CLIA; FDA clearance or approval is not required for clinical use.

Terminology and Test Definitions

Nucleic acid hybridization / PCR (brief)

DefinitionNucleic acid hybridization technologies use complementary properties of DNA double-helix structures to anneal DNA fragments from different sources for identification of microorganisms.

Clinical utilityThese methods offer increased sensitivity and specificity, reduced time to result, and high-throughput capability compared with traditional microbiology.

LimitationsPotential limitations include contamination risk, lack of standardization/validation for some assays, complex interpretation, and increased cost.

Terminology (short definitions)

PCRPolymerase chain reaction; a nucleic acid amplification method to replicate DNA sequences.

qPCRQuantitative polymerase chain reaction; PCR variant that measures DNA quantity in real time.

NAATsNucleic acid amplification tests; molecular assays (e.g., PCR) for detecting pathogen nucleic acid.

FRETFluorescent resonance energy transfer; a technique used in some hybridization-based detection assays.

rRT-PCRReal-time reverse transcriptase–PCR; used for RNA viruses and reported as a terminology entry in the policy.

Laboratory-developed test (LDT)

DefinitionLaboratory-developed test (LDT): a test developed and validated by a laboratory for in-house use.

Regulatory statusLDTs are regulated by CMS as high-complexity tests under CLIA '88.

FDA clearanceLDTs are not approved or cleared by the U.S. Food and Drug Administration; FDA clearance/approval is not currently required for clinical use.

Validation requirementLabs that develop LDTs must validate and perform those tests in-house per the policy statement.

NAAT / PCR and resistance gene detection

CapabilityNAATs (such as PCR) can be used for direct detection of resistance genes (example: mecA for methicillin resistance in Staphylococcus aureus).

LimitationNAATs will not detect novel resistance mechanisms or uncommon phenotypes not targeted by the assay.

Clinical noteDetection of known resistance genes by NAATs can inform management but does not replace phenotypic susceptibility testing when needed.