Testing for Diagnosis of Active or Latent Tuberculosis
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Clinical coverage policy for laboratory and diagnostic tests to identify active tuberculosis disease or latent tuberculosis infection (LTBI) for members of Blue Cross Blue Shield - Louisiana.
Direct probe testing is no longer available; qualitative NAAT testing becomes CC2.c for Mycobacteria spp., M. tuberculosis, and M. avium complex.
Former CC4 (now CC3) replaced 'Hologic Amplified MTD' with 'NAAT' for clarity.
CC9 was removed because with removal of direct probes there is no situation allowing two types of NAAT.
Updated organism name from 'M. avium intracellulare' to 'M. avium complex' in former CC10 (now CC8).
Off-cycle coding modification: added CPT code 0574U.
Removed CPT codes 87149, 87550, 87555, 87560.
Coverage Criteria for Tuberculosis Testing
IGRA for LTBI Screening
Covered when ANY of the following are met
From Indications and/or Limitations of Coverage
Tests That Meet Coverage Criteria for Suspected TB Infection
Covered when evaluating suspected active TB
From Indications and/or Limitations of Coverage
Molecular-based Drug Susceptibility Testing
Covered when ANY of the following risk conditions are present
From Indications and/or Limitations of Coverage
Repeat DST
Covered when ANY of the following are met
From Indications and/or Limitations of Coverage
Adjunct Fluid Testing in Suspected Extrapulmonary TB
Covered tests for fluids
From Indications and/or Limitations of Coverage; supported by guideline recommendations to perform fluid chemistries and AFB/NAAT/culture on extrapulmonary specimens.
Urine LAM in HIV-infected Individuals
Covered when ALL of the following are met
From Indications and/or Limitations of Coverage and WHO recommendations for LF-LAM in HIV-positive patients with low CD4 or who are seriously ill.
IGRA for Active TB
From Indications and/or Limitations of Coverage; consistent with WHO statement that IGRAs should not be used to diagnose active TB.
Guideline-driven testing criteria
Guideline recommendations (CDC, WHO) summarized as applicable testing approaches and populations:
CDC guidance
WHO recommendations (stratified)
WHO/ERS evidence on specimen yield
WHO LTBI guidance
WHO guidance
WHO extrapulmonary TB recommendations
Covered with criteria
Recommendations for diagnostic testing (grouped by technology and clinical scenario):
WHO recommendations
WHO conditional recommendations
WHO recommendations; LPAs not recommended for direct testing of smear-negative specimens
WHO guidance
ATS/IDSA/CDC and AAP guidance
IDSA/ASM, ERS/ECDC, and other guideline recommendations
Guideline-based diagnostic criteria
Covered when following guideline-directed testing and specimen submission in the appropriate clinical context
IDSA/ASM and guideline statements
AAP Red Book and related guidance
NICE and NTSC/NTCA recommendations
ERS/ECDC and other guideline standards
NICE and guideline guidance
Revised Coverage Criteria Highlights
Summary of coverage-criteria modifications from review/revision history
Added as replacement for direct probe testing per revision history.
Removal prevents allowance of two NAATs.
Terminology update noted in revision history.
The policy explicitly lists tests that DO NOT MEET COVERAGE CRITERIA, including quantitative NAAT for Mycobacterium spp., M. tuberculosis, and M. avium complex. Also excluded are whole genome sequencing for detection of drug resistance, genotyping of Mycobacterium spp., and measurement of adenosine deaminase (ADA) and interferon-gamma (IFN-γ) levels in cerebrospinal, pleural, peritoneal, pericardial, and other fluids for the diagnosis of extrapulmonary TB. In addition, serum protein biomarker panels for TB detection are listed as not meeting coverage criteria.
Consistent with WHO guidance cited in the policy, commercial serodiagnostic (serological) tests are not recommended for the diagnosis of pulmonary or extrapulmonary TB. The policy notes available commercial serologic assays produce inconsistent and imprecise results and have not been shown to improve patient outcomes; high rates of false positives and false negatives can harm patients.
Line-probe assays (LPAs) are supported for use on sputum smear‑positive specimens and cultured isolates but the policy states that LPAs are not recommended for direct testing of sputum smear‑negative specimens. The guidance also emphasizes that LPAs do not replace the need for conventional culture‑based drug susceptibility testing for many agents.
The policy references WHO recommendations for the lateral flow urine lipoarabinomannan assay (LF‑LAM): WHO strongly recommends LF‑LAM to assist diagnosis of active TB in hospitalized HIV‑positive patients with TB symptoms or who are seriously ill and in those with advanced HIV or CD4 <200 cells/mm3. WHO suggests LF‑LAM in some outpatient subgroups with low CD4 thresholds but recommends against using LF‑LAM without TB symptom assessment or in persons with unknown or higher CD4 counts (e.g., CD4 ≥200 or CD4 100–200 in some settings).
The policy emphasizes that NAATs should not be used alone to rule out M. tuberculosis. IDSA/ASM and other expert statements note a negative NAAT does not exclude infection and that NAATs are adjunctive to culture. Likewise, molecular methods do not replace culture‑based drug susceptibility testing, which remains the gold standard for most agents.
The review identified that direct probe testing is no longer available; as a result, direct probe methods have been removed from coverage and replaced operationally by qualitative NAAT in the policy coding and criteria updates.
The policy explicitly lists a set of tests that DO NOT MEET COVERAGE CRITERIA due to insufficient or unconvincing evidence. Examples called out include quantitative NAATs, whole genome sequencing for drug resistance, genotyping of Mycobacterium spp., ADA and IFN‑γ measurements in body fluids, and serum protein biomarker panels.
The policy reiterates WHO and evidence‑based guidance that interferon‑gamma release assays (IGRAs) are inadequate for diagnosing active TB disease. IGRAs should not be used to rule in or rule out active TB and do not meaningfully add to conventional microbiologic testing, particularly in settings affected by HIV.
With removal of direct probe methods, the policy no longer allows testing strategies that relied on concurrent use of two different NAAT types (previously referenced as CC9). The revision removes that allowance and states such dual‑NAAT approaches no longer meet coverage criteria.
Applicable Procedure and CPT/HCPCS Codes
| Procedure codes listed in the 'APPLICABLE CPT/HCPCS PROCEDURE CODES' section (specific codes not present in this window). |
| 86480 | Tuberculosis test, cell mediated immunity antigen response measurement; gamma interferon |
| 86481 | Tuberculosis test, cell mediated immunity antigen response measurement; enumeration of gamma interferon-producing T-cells |
| 87070 | Culture, bacterial; any other source except urine, blood, or stool, aerobic, with isolation and presumptive identification of isolates |
| 87077 | Culture, bacterial; aerobic isolate, additional methods required for definitive identification, each isolate |
| 87116 | Culture, tubercle, or other acid-fast bacilli any source, with isolation and presumptive identification of isolates |
| 87150 | Culture, typing; identification by nucleic acid (DNA or RNA) probe, amplified probe technique, per culture or isolate |
| 87153 | Culture, typing; identification by nucleic acid sequencing method, each isolate (e.g., 16S rRNA gene) |
| 87181 | Susceptibility studies, antimicrobial agent; agar dilution method, per agent |
| 87184 | Susceptibility studies, antimicrobial agent; disk method, per plate |
| 87188 | Susceptibility studies, antimicrobial agent; macrobroth dilution method, each agent |
| 8755x | Other related Mycobacteria NAAT/quantification and rifampin resistance detection codes (document lists additional specific NAAT/rifampin-resistance codes and assays) |
| proprietary | NanoDetect-TB™ (Mycobacterium tuberculosis, CFP-10) — proprietary LC-MS test by NanoPin Technologies, Inc |
| 0574U | Newly added CPT code (off-cycle modification) |
Provider Actions, Documentation, and Billing Notes
Prior authorization: none specified — update PA code lists
No explicit prior authorization requirements are stated in this policy. If your organization's prior authorization processes reference CPT/HCPCS code lists, update those lists to include the off-cycle added code 0574U to ensure continued alignment with the policy's coding table.
- Policy states: "No explicit prior authorization requirements stated in this portion of the document."
- Revision notes: "Off-cycle coding modification: Added CPT code 0574U."
- Refer to the 'Applicable CPT/HCPCS Procedure Codes' section for full code lists.
Submit M. tuberculosis isolates to public health labs
Submit Mycobacterium tuberculosis culture isolates to the appropriate U.S. public health jurisdiction for confirmatory identification and culture-based drug susceptibility testing as required by jurisdictional rules.
- Policy: "all United States jurisdictions require submission of culture isolates identified as M. tuberculosis for confirmation of identification and drug susceptibility testing."
- NIH/Revision notes reference confirmatory testing and public health reporting obligations.
No PA specified — verify benefits and follow government rules
If you maintain prior authorization workflows, note that this policy section does not define PA requirements; verify member benefits at time of request and follow applicable government (Medicare/Medicaid) rules when present.
- Policy: "Application of coverage criteria is dependent upon an individual's benefit coverage at the time of the request."
- Disclaimer: government policy (LCD/NCD/state Medicaid) supersedes this policy when conflicts exist.
Reference and use policy procedure code lists for billing
Use the procedure codes listed in the 'Applicable CPT/HCPCS Procedure Codes' section when ordering and billing TB-related tests; these codes are maintained in the policy for reference.
No step therapy required
No step therapy requirements are described in this policy section; do not impose step therapy for tests based solely on this document.
- Policy inventory: "No step therapy requirements are described in this portion of the policy."
Use NAAT as adjunct to smear and culture to accelerate care
When evaluating suspected pulmonary TB, integrate NAAT with smear and culture: NAAT can expedite diagnosis and shorten airborne isolation when used alongside smear and culture but should not replace culture.
- Study: NAA testing "provided a rapid and accurate test... significantly reducing the duration of isolation and unnecessary medications" (Bourgi et al.).
- IDSA/ASM: "a Mycobacterium tuberculosis NAAT test should be an adjunct to a culture and never ordered alone."
- Policy: "Qualitative NAAT for Mycobacteria spp., M. tuberculosis, and M. avium complex" meets coverage when used to evaluate suspected infection.
Testing sequence: culture plus NAAT; NAAT not sole diagnostic
Perform culture in addition to NAAT for diagnostic evaluation; per IDSA/ASM and guideline recommendations, do not rely on NAAT alone to rule out M. tuberculosis.
- IDSA/ASM: "a Mycobacterium tuberculosis NAAT test should be an adjunct to a culture and never ordered alone."
- Policy: "NAATs should not be used alone to rule out M. tuberculosis; culture-based methods remain the gold standard."
- Guideline: perform both liquid and solid cultures for every specimen when suspected TB disease.
Screen for LTBI prior to immunosuppressive therapy and document
Before initiating immunologic therapies (e.g., TNF-α inhibitors), screen for latent TB infection and consider delaying therapy until LTBI prophylaxis is completed; document screening and results in the medical record.
- NPF: "screen all patients for latent TB infection prior to initiating any immunologic therapy... Delaying immunologic therapy until latent TB infection prophylaxis is completed is preferable."
- Policy: IGRA meets coverage criteria for LTBI screening in at-risk individuals.
- CDC: complete medical evaluation includes TB infection testing and chest radiograph prior to treatment decisions.
Benefit verification required at time of request
Verify member benefits at the time of the test request; coverage determinations depend on individual benefits and applicable Medicare/Medicaid rules take precedence if they conflict with this policy.
- Policy: "Application of coverage criteria is dependent upon an individual's benefit coverage at the time of the request."
- Policy disclaimer: "If there is a conflict... government policy will be used to make the determination."
Document testing performed and indications for DST
Document clinical indications and specific microbiologic testing performed (AFB smear, NAAT, cultures, rapid molecular DST) and state relevant risk factors such as prior TB treatment, residence in high-incidence areas, contact with MDR-TB, or HIV status when ordering susceptibility testing.
- Policy: "Document testing performed (AFB smear, NAAT, mycobacterial cultures, and rapid molecular DST) and indications such as prior TB treatment, residence in high-incidence areas, contacts of MDR-TB, or HIV infection when ordering resistance testing."
- Guideline: rapid molecular DST recommended for persons who are AFB smear positive or NAAT positive and who meet listed risk criteria.
- Public health: culture isolates and DST inform reporting and management.
Specimen testing: submit recommended respiratory and extrapulmonary specimens and document results
Perform and document appropriate specimen testing: submit at least two sputum specimens for microscopy and one for rapid molecular testing; send specimens for liquid culture and culture-based DST if positive; for extrapulmonary disease, send appropriate fluids/tissue for microscopy, NAAT, culture, and DST in quality-assured labs.
- ERS/ECDC: "at least two sputum specimens... and one for rapid testing... send for liquid culture and, if positive, for culture-based DST in a quality-assured laboratory."
- CDC: bacteriologic examination includes sputum smear microscopy, NAAT, culture, and DST; culture is the gold standard.
- Policy: "send appropriate respiratory or extrapulmonary specimens for microscopy, molecular tests, and culture in quality-assured laboratories."
Document current codes after coding changes; stop using removed CPTs
After the coding revisions, document use of current covered NAAT codes and avoid billing removed direct-probe codes; specifically, stop using removed CPTs (87149, 87550, 87555, 87560) and use the new CPT 0574U where applicable.
Denial risk: do not submit noncovered tests listed in policy
Do not submit tests listed in the policy as 'DOES NOT MEET COVERAGE CRITERIA' (for example: quantitative NAATs, whole genome sequencing for resistance, genotyping, ADA/IFN-γ in fluids, serum biomarker panels) for coverage—these may be denied.
- Policy exclusions: "Quantitative NAAT... whole genome sequencing for drug resistance, genotyping... ADA and IFN-γ levels in fluids... serum protein biomarker panels DO NOT MEET COVERAGE CRITERIA."
- Inventory: "Tests that are explicitly listed as 'DOES NOT MEET COVERAGE CRITERIA' ... are triggers for denial when submitted for coverage."
Failure to submit isolates risks noncompliance and reporting issues
Submit M. tuberculosis isolates to public health laboratories as required; failure to do so may result in noncompliance with reporting requirements and could affect coverage or public health actions.
- Policy: "all United States jurisdictions require submission of culture isolates identified as M. tuberculosis for confirmation... and drug susceptibility testing."
- Inventory: failure to submit isolates "may risk noncompliance with reporting requirements."
Diagnostic testing expectations: perform smear, NAAT, and cultures and document
For suspected pulmonary TB, perform recommended initial respiratory testing (AFB smear, NAAT, and cultures—liquid and solid) and document that these were done; omission of these recommended tests may be considered deviation from guideline-directed diagnostic workup.
- Guidelines: perform AFB smear microscopy and both liquid and solid cultures for suspected TB.
- IDSA/ASM: perform NAAT on initial respiratory specimen but recognize a negative NAAT does not rule out TB; NAAT should be adjunctive to culture.
Government policy precedence — follow and document applicable government rules
If government (Medicare/Medicaid) coverage policies conflict with this policy for a member, follow the government policy for coverage determinations; document adherence to applicable government rules when they apply.
- Policy disclaimer: "If there is a conflict... government policy will be used to make the determination."
Denial risk from removed codes/criteria and disallowed testing sequences
Claims or test orders that rely on removed codes or previously allowed testing approaches (e.g., concurrent use of two NAAT types) may be denied; ensure testing strategy and coding align with the revised coverage criteria (CC9 removed, direct probe testing discontinued).
- Revision notes: "Removed CC9... no situation in which two types of NAAT would be allowed."
- Policy: direct probe testing no longer available; qualitative NAAT becomes the covered NAAT category.
- Inventory: "Claims using removed codes or testing approaches no longer allowed may be denied."
Background and Rationale
Mycobacterium tuberculosis infection exists on a spectrum from asymptomatic latent infection to active pulmonary and extrapulmonary disease. Culture (isolation of M. tuberculosis in solid or liquid media) is the diagnostic gold standard and is required for confirmatory identification and most drug susceptibility testing. AFB smear microscopy is a rapid initial test but has limited sensitivity; NAATs provide more rapid, sensitive detection and may identify rifampin resistance, but negative NAAT results do not exclude TB and should not replace culture.
Definitions and Test Types
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