Currentblue cross blue shield - tennesseePolicy N/A

Testing for Diagnosis of Active or Latent Tuberculosis

Defines coverage criteria and limitations for laboratory and diagnostic tests used to detect active tuberculosis (TB) and latent TB infection (LTBI), including IGRAs, TST, AFB smear, culture, NAAT/NAAT-based testing, drug susceptibility testing, and select fluid analyses; describes tests that do not meet coverage criteria.

Policy Summary

Payerblue cross blue shield - tennessee

PolicyTesting for Diagnosis of Active or Latent Tuberculosis

Policy CodePolicy N/A

Change TypeAdoption of Avalon recommendation

Effective DateJul 1, 2023

Next Review DateN/A

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

SourceLink

POLICY UPDATE CHANGES

Policy adopted Avalon policy recommendation.

MultiplePolicy scope

CoveredIGRA coverage

ExcludedIGRA active TB exclusion

WGS/Quant NAATExcluded advanced tests

Children repeat-testing threshold

NAAT/Xpert/Truenat/LPADiagnostic modalities referenced

Coverage Summary

This policy defines coverage criteria for laboratory and diagnostic testing for both active tuberculosis (TB) and latent TB infection (LTBI), including AFB smear, mycobacterial culture and culture-based drug susceptibility testing, nucleic acid amplification tests (NAATs, including Xpert/Truenat), interferon-gamma release assays (IGRAs) and tuberculin skin testing (TST), line probe assays, urine LF-LAM in specified HIV contexts, and selected fluid analyses; it also lists tests that do not meet coverage criteria (for example, quantitative NAAT, whole genome sequencing, genotyping, and certain fluid biomarker assays). The policy adoption is effective 2023-07-01.

Key decision thresholds

Foreign country TB incidence threshold≥20 per 100,000

High primary MDR-TB prevalence threshold≥2%

HIV CD4 threshold for urine LAM testing (inpatient/outpatient)≤100 cells/µL for testing; WHO also cites CD4 <200 cells/mm3 for inpatient use and <100 cells/mm3 for outpatient suggestion

Pretest probability threshold for repeat NAAT in children5%

CD4 threshold cited for LF-LAM inpatient recommendation200 cells/mm3

Coverage / Medical Necessity Criteria

LTBI Screening - IGRA

IGRA meets coverage criteria when ALL of the following are met:

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Guideline and Evidence Recommendations

Tuberculosis infection ranges from asymptomatic, noninfectious latent TB infection (LTBI) to clinically apparent, often pulmonary, active TB disease; latent infection is identified by immune-response tests (TST or IGRA) while active disease requires microbiologic evidence (AFB smear, culture, NAAT) and clinical correlation. IGRAs measure interferon-gamma release and have high specificity (>95%) with sensitivity around 80–90% for LTBI but are not appropriate for diagnosing active TB. NAATs (PCR-based assays such as Xpert/MTB-RIF and Truenat) provide rapid detection of M. tuberculosis and rifampicin resistance and have high reported sensitivity and specificity in many settings, although culture remains the most sensitive method and is the reference standard for species identification and phenotypic drug susceptibility testing. Analytic validity and clinical utility vary by context (for example, reduced smear sensitivity in HIV and extrapulmonary disease, specific recommendations for urine LF-LAM in HIV-positive patients with low CD4, and guidance on repeated NAAT testing in children depending on pretest probability), so test selection should follow the guideline-specified use cases and specimen-type considerations.

Select evidence highlights

IGRA performanceSpecificity >95%; sensitivity 80-90%

TST sensitivity

Provider Actions and Billing Guidance

Prior Authorization

Avoid simultaneous duplicate molecular tests

Do not order simultaneous direct probe, amplified probe, and/or quantification assays for the same organism in a single encounter; such simultaneous ordering does not meet coverage criteria.

Documentation Required

Document indication for molecular-based DST

When requesting molecular-based drug susceptibility testing (molecular DST) on sputum that is AFB smear–positive or Hologic MTD–positive, document the indication by recording at least one qualifying criterion: prior TB treatment, born in or lived ≥1 year in a country with TB incidence ≥20 per 100,000 or primary MDR-TB prevalence ≥2%, known contact of an MDR-TB case, or HIV infection.

Coding

No specific CPT/HCPCS/ICD-10 codes listed in Part 1mixed

No codes listed

No explicit billing/CPT/HCPCS/ICD codes in this sectionmixed

No codes listed

Definitions

Term	Definition
IGRA	Interferon gamma release assay
AFB	Acid fast bacilli
LAM	Lipoarabinomannan
NAAT/NAAT-based	Nucleic acid amplification test(s), including PCR and amplified probe methods
Xpert MTB/RIF, Xpert Ultra	Rapid nucleic acid amplification tests (NAATs) for detection of M. tuberculosis complex and rifampicin resistance.
LF-LAM	Lateral flow urine lipoarabinomannan assay used to assist diagnosis of active TB in HIV-positive patients under specified conditions.
LPA / SL-LPA	Line probe assays for detection of resistance to first-line (LPA) and second-line (SL-LPA) anti-TB drugs.

Revision History

2023-07-01policy_adoptionLatest

Effective date listed as 7/1/2023. Policy adopted Avalon policy recommendation.

Policy Summary

Payerblue cross blue shield - tennessee

PolicyTesting for Diagnosis of Active or Latent Tuberculosis

Policy CodePolicy N/A

Change TypeAdoption of Avalon recommendation

Effective DateJul 1, 2023

Next Review DateN/A

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

SourceLink

On This Page

Approximately 71%-82%

NAAT (reported) accuracySensitivity ~96%, specificity ~99%

Urine LAM in CD4<100Sensitivity 67.9%; specificity 97.6%

Certainty for Xpert Ultra as initial adult testHigh certainty (WHO) for adults without recent TB

Certainty for Xpert in childrenLow to very low certainty for pediatric specimen accuracy

Guideline sourcesWHO, ATS/IDSA/CDC, NIH and others cited

Documentation Required

Repeat DST justification

To support repeat drug susceptibility testing (DST), document either (a) sputum cultures that remain positive after 3 months of treatment, or (b) bacteriological reversion from negative to positive.

Documentation Required

LTBI testing intent-to-treat

Perform LTBI testing (IGRA or TST) only when there is intent to treat if the test is positive; document that testing is being done to identify individuals who would benefit from preventive therapy.

Documentation Required

Use guideline-preferred tests for initial diagnosis

When using guideline-preferred NAATs and other tests for initial diagnosis of pulmonary or extrapulmonary TB, document the following to justify test selection: specimen type, clinical signs/symptoms, prior TB history, HIV status, and estimated pretest probability.

Specimen type (eg, sputum, CSF, pleural/pericardial/peritoneal fluid, gastric aspirate, nasopharyngeal aspirate, stool)
Clinical signs and symptoms consistent with TB
Prior history of TB and timing of prior treatment
HIV status (including CD4 when applicable)
Pretest probability of disease

Prior Authorization

Rifampicin resistance testing preference

Prefer rapid molecular testing for rifampicin-resistance (eg, Xpert/Xpert Ultra, Truenat, or LPAs) as initial testing in indicated patients; document risk factors for MDR/RR-TB (prior TB treatment, residence/birth in high-incidence/high-MDR area, contact of MDR-TB case, HIV infection) to justify molecular DST.

Billing Rule

Specimen submission for culture and DST

Submit appropriate specimens for both rapid molecular testing and liquid and solid mycobacterial culture; if culture is positive, ensure culture-based DST is performed to determine resistance to additional agents and for public health reporting.

Denial Risk

Repeated testing limitations in children

Repeated Xpert/Xpert Ultra testing in children is limited by WHO recommendations: repeated tests are not supported when pretest probability <5% and initial result negative (or trace positive for Ultra), and repeat testing (total of two tests) is allowed only when pretest probability ≥5% per specimen-type guidance. Claims for repeats outside these criteria may lack clinical justification.

Documentation Required

HIV-positive patient LF-LAM testing criteria

For urine LF-LAM testing in HIV-positive patients, document inpatient status or that the patient is seriously ill or has advanced HIV and record symptoms and CD4 count (≤100 cells/µL for outpatient suggestion; ≤200 cells/mm3 for inpatient recommendation) to justify LF-LAM use per WHO guidance.

Documentation Required

LTBI testing choice and confirmation

For LTBI testing, document the patient’s age and BCG vaccination history, risk of progression, and rationale for choosing IGRA versus TST; if confirmatory testing is performed after an initial positive test, document both test results to support an LTBI diagnosis.

Billing Rule

Policy adoption effective date

Policy adoption effective date: 2023-07-01. Providers should bill in accordance with this policy from that date forward.