ModifiedBlue Cross Blue Shield - OklahomaPolicy CPCPLAB027

Testing for Diagnosis of Active or Latent Tuberculosis

Lab testing and reimbursement criteria for diagnosing or screening for active and latent tuberculosis for BCBSOK members; governs provider billing and applicable laboratory tests.

Policy Summary

PayerBlue Cross Blue Shield - Oklahoma

PolicyTesting for Diagnosis of Active or Latent Tuberculosis

Policy CodePolicy CPCPLAB027

Change TypeRevised — material coverage clarifications added

Effective DateFeb 1, 2024

Next Review Date

Key ActionDocument presence of clinical or epidemiologic criteria (prior TB treatment, country of birth/residence, contact with MDR-TB, or HIV status) when requesting molecular-based drug susceptibility testing.

SourceLink

POLICY UPDATE CHANGES

Document updated with literature review and reimbursement information revised for clarity.

Reimbursement items #2 and #3 were combined; added molecular-based drug susceptibility testing reimbursable for certain high-risk patients.

Added reimbursement clarification that for all suspected TB infections, AFB smear/stain, culture and culture-based drug susceptibility testing may be reimbursable.

1.0Policy version

02/01/2024Effective date

IGRA reimbursable for LTBIIGRA stance

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Not reimbursable for active TB

4Molecular DST criteria

Coverage Criteria for TB Testing

Reimbursable testing for latent TB and suspected TB

Covered when any of the following conditions apply:

IGRA for latent TB screening: Interferon gamma release assay (IGRA) may be reimbursable to diagnose or screen for latent tuberculosis infection in individuals who are at risk for infection with Mycobacterium tuberculosis (Mtb) or in individuals unlikely to be infected when screening is required by law.

AFB smear/culture for suspected TB: For all suspected TB infections, AFB smear/stain; culture and culture-based drug susceptibility testing of Mycobacteria spp. may be reimbursable.

Direct/amplified probe NAAT: Direct probe or amplified probe nucleic acid-based testing, including PCR, may be reimbursable for Mycobacteria spp, M. tuberculosis, and M. avium intracellulare.

Molecular-based drug susceptibility testing: For individuals whose sputum is AFB smear positive or Hologic Amplified MTD positive, molecular-based drug susceptibility testing may be reimbursable when one of the specified clinical or epidemiologic criteria is met (see Molecular-based DST criteria).

Repeat drug susceptibility testing may be reimbursable if sputum cultures remain positive after 3 months of treatment or when there is bacteriological reversion from negative to positive.

Fluid analysis for extrapulmonary TB: For individuals with pleural effusion, pericardial effusion, or ascites and suspected TB infection, cell counts, protein, glucose, and lactate dehydrogenase (LDH) concentrations of cerebrospinal, pleural, peritoneal, pericardial, and other fluids may be reimbursable.

Not reimbursable / Exclusions

The following tests are specified as not reimbursable:

IGRA in active TB: Interferon gamma release assay (IGRA) is not reimbursable for individuals with active tuberculosis.

Simultaneous duplicate molecular tests: Simultaneous ordering of any combination of direct probe, amplified probe, and/or quantification for the same organism in a single encounter is not reimbursable.

Quantitative NAAT not reimbursable: Quantitative nucleic acid testing for Mycobacterium spp, M. tuberculosis, and M. avium intracellulare is not reimbursable.

ADA and IFN-gamma in fluids not reimbursable: Testing of adenosine deaminase (ADA) and interferon-gamma (IFNγ) levels in cerebrospinal, pleural, peritoneal, pericardial, and other fluids for the diagnosis of extrapulmonary TB are not reimbursable.

Special-case reimbursable test

Urine LAM in HIV with low CD4 and TB symptoms: In HIV-infected individuals with CD4 cell counts ≤100 cells/microL who have signs and symptoms of tuberculosis, urine-based detection of mycobacterial lipoarabinomannan (LAM) may be reimbursable.CD4 ≤100 cells/microL

Molecular-based drug susceptibility testing — reimbursable indications

Molecular-based drug susceptibility testing may be reimbursable when ANY one of the following is met:

Prior TB treatment: The individual has been treated for TB in the past.

Residence in moderate/high TB incidence country: The individual was born in or has lived for at least 1 year in a foreign country with at least a moderate TB incidence (≥20 per 100,000) or a high primary multi-drug resistant (MDR)-TB prevalence (≥2%).>=1 year; incidence >=20/100,000 or MDR prevalence >=2%

Contact of MDR-TB case: The individual is a contact of an individual with MDR-TB.

HIV infection: The individual is HIV infected.

Reimbursable baseline TB diagnostic tests

For all suspected TB infections, the following tests may be reimbursable:

Standard TB diagnostic tests: Acid fast bacilli (AFB) smear/stain; culture and culture-based drug susceptibility testing of Mycobacteria spp.

The policy specifies several additional coverage notes for tuberculosis testing. IGRA is not reimbursable for individuals with active tuberculosis. Simultaneous ordering of any combination of direct probe, amplified probe, and/or quantification for the same organism in a single encounter is not reimbursable. In addition, quantitative nucleic acid testing (NAAT) for Mycobacterium spp., M. tuberculosis, and M. avium intracellulare is not reimbursable.

The policy update history does not list any other explicit exclusions beyond those summarized elsewhere in the reimbursement information. The 02/01/2024 and prior updates clarified and revised reimbursement language but did not add additional exclusion categories in the cited update notes.

Within the cited update history and accompanying revisions, the document does not state any discrete items labeled as 'not medically necessary.' Reimbursement intent and criteria were clarified, but no separate 'not medically necessary' statements appear in these chunks.

Procedure and Diagnostic Codes

Procedure/diagnostic codes (listed)mixed

81099
82945
83520
83615
84157
84311
86480
86481
87070
87077

1–10 of 31

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Provider Responsibilities, Prior Authorization, and Billing

Note

Product-specific reimbursement criteria

BCBSOK has implemented certain lab management reimbursement criteria. Not all requirements apply to each product. Providers are urged to review Plan documents for eligible coverage for services rendered.

Product-specific rules may apply; verify member's plan documents for coverage, benefit limits, and product-specific management rules.

Documentation Required

Claims documentation and coding

Providers are responsible for submission of accurate documentation of services performed. Claims are subject to code edit protocols and review against plan coverage, contract terms, medical policies, clinical payment and coding policies, and coding software logic. Upon request, the provider is urged to submit any additional documentation.

Use HIPAA-approved code sets (CPT, HCPCS, ICD-10, NDC) and follow industry coding guidelines (AMA, CMS, NCCI/CCI edits, UB).
Claims may be reviewed and audited; include supporting clinical documentation when requested.

Background and Rationale

Interferon gamma release assays (IGRAs) are described as the blood-based immunologic tests used to diagnose or screen for latent tuberculosis infection in at-risk individuals and where screening is legally required; however, the policy explicitly states that IGRA is not reimbursable for active tuberculosis. For suspected active TB, microbiologic testing including acid-fast bacilli (AFB) smear/stain, culture, and culture-based drug susceptibility testing are listed as reimbursable baseline diagnostics. Nucleic acid amplification tests (NAAT), including direct or amplified probe methods and PCR, may be reimbursable to identify Mycobacteria species such as M. tuberculosis and M. avium intracellulare, but the policy prohibits quantitative NAAT and disallows simultaneous duplicate molecular tests for the same organism in a single encounter. Molecular-based drug susceptibility testing is addressed separately and may be reimbursable when specified clinical or epidemiologic risk criteria are met.

Key Definitions

inv-19: Interferon gamma release assay (IGRA)

DefinitionInterferon gamma release assay (IGRA): a blood-based immunologic test used to diagnose or screen for latent tuberculosis infection in individuals at risk for Mycobacterium tuberculosis (Mtb) infection or when screening is required by law; not reimbursable for individuals with active tuberculosis.

Reimbursable indicationMay be reimbursable to diagnose or screen for latent TB in individuals who are at risk for Mtb infection or when screening is legally required.

Not reimbursableIGRA is not reimbursable for individuals with active tuberculosis.

Clinical contextUsed for latent TB screening rather than for diagnosis of active disease; see exclusions for active TB testing.

inv-20: Acid-fast bacilli (AFB) smear/culture and NAAT

Definition

Policy Summary

PayerBlue Cross Blue Shield - Oklahoma

PolicyTesting for Diagnosis of Active or Latent Tuberculosis

Policy CodePolicy CPCPLAB027

Change TypeRevised — material coverage clarifications added

Effective DateFeb 1, 2024

Next Review Date

SourceLink

On This Page

Serum protein biomarkers not reimbursable: Testing of serum protein biomarkers or panels of biomarkers for the detection and diagnosis of TB are not reimbursable.

Denial Risk

Reimbursement conditions for molecular-based DST

Molecular-based drug susceptibility testing (DST) for tuberculosis is reimbursable only when documentation shows the specimen is AFB smear positive or Hologic Amplified MTD positive and at least one of the following clinical or epidemiologic criteria is met. Repeat DST may be reimbursable in specified treatment/follow-up situations. Absent documentation meeting these criteria, molecular DST may not be reimbursed.

Reimbursable when specimen is AFB smear positive or Hologic Amplified MTD positive AND one of: prior TB treatment; born in or lived ≥1 year in a country with TB incidence ≥20/100,000 or MDR-TB prevalence ≥2%; contact of a person with MDR-TB; HIV infection.
Repeat DST reimbursable when sputum cultures remain positive after 3 months of treatment or when bacteriologic reversion from negative to positive occurs.

Documentation Required

Required documentation for molecular DST reimbursement

For reimbursement of molecular DST, providers must document the presence of the required specimen result (AFB smear positive or Hologic Amplified MTD positive) and at least one qualifying clinical/epidemiologic criterion, or document the repeat-testing condition when applicable.

Document specimen results (AFB smear, Hologic Amplified MTD) in the medical record and include with claim or upon request.
Document which qualifying criterion is met (prior TB treatment; country of origin/residence with TB/MDR prevalence thresholds; known contact with MDR-TB; HIV infection) or the repeat-testing indication (persistent positive cultures after 3 months or bacteriologic reversion).

Prior Authorization

Prior authorization and provider action note

Providers should review plan documents for product-specific management rules and any prior authorization requirements. This policy does not list explicit prior authorization statements; absence of a statement here does not guarantee no prior authorization for a specific product.

If prior authorization is required by the member's product, obtain approval per plan procedures before rendering services.
Check member's benefit documents for coverage determination and any pre-authorization, step-therapy, or quantity limit rules.

Acid-fast bacilli (AFB) smear/stain and culture: microbiologic tests to identify Mycobacteria species; culture-based drug susceptibility testing is included as part of diagnosis for suspected TB.

NAAT definitionDirect probe or amplified probe nucleic acid-based testing (including PCR) for Mycobacteria spp, M. tuberculosis, and M. avium intracellulare.

Reimbursable baseline testsFor all suspected TB infections, AFB smear/stain, culture, and culture-based drug susceptibility testing may be reimbursable.

Supporting evidenceNucleic acid amplification tests and sputum smear microscopy are referenced as diagnostic methodologies in the policy references.

inv-21: Molecular-based drug susceptibility testing (DST)

DefinitionMolecular-based drug susceptibility testing (DST): laboratory assays that detect genetic markers of resistance in Mycobacterium tuberculosis to guide selection of effective therapy.

Reimbursable clinical indicationsMay be reimbursable for individuals whose sputum is AFB smear positive or Hologic Amplified MTD positive when ANY one of: prior TB treatment; born in or lived ≥1 year in a country with TB incidence ≥20/100,000 or MDR-TB prevalence ≥2%; contact of an MDR-TB case; or HIV infected.

Repeat DSTRepeat drug susceptibility testing may be reimbursable if sputum cultures remain positive after 3 months of treatment or with bacteriological reversion from negative to positive.