Modifiedharvard pilgrim health carePolicy N/A

Laboratory testing for diagnosis of active and latent tuberculosis

Coverage rules for laboratory tests used to diagnose active tuberculosis (TB) and to screen for latent TB infection (LTBI) for Harvard Pilgrim Health Care commercial products. Specifies which tests meet or do not meet coverage criteria and situations requiring repeat or molecular susceptibility testing.

Policy Summary

Payerharvard pilgrim health care

PolicyLaboratory testing for diagnosis of active and latent tuberculosis

Policy CodePolicy N/A

Change TypeCoding updates and new policy entry

Effective DateNov 1, 2025

Next Review DateSep 1, 2026

Key ActionDocument clinical indication including risk factors, HIV status and CD4, prior TB treatment history, contact with MDR-TB, or residence in high-incidence/MDR-prevalence countries.

SourceLink

POLICY UPDATE CHANGES

Removed CPT/HCPCS codes 87149, 87550, 87555, 87560 from the coding grid.

Added CPT/HCPCS codes 87564 and 0574U to the coding grid.

Policy created to support coverage guidelines, effective for dates of service beginning Nov. 1, 2025.

IGRA coveredIGRA indications covered

AFB/NAAT coveredCore diagnostic tests covered

Advanced methodsNot covered test types

LAM eligible

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Targeted LAM coverage

Ordering limitOrder limitation

~70bibliographic references cited

Coverage Criteria for TB Testing

IGRA (latent TB) coverage

IGRA testing meets coverage criteria when ANY of the following apply:

IGRA indications: a. Individuals who are at risk for infection with Mycobacterium tuberculosis (Mtb). b. Individuals who are unlikely to be infected with Mtb when screening is obliged by law.

From policy: IGRA MEETS COVERAGE CRITERIA for diagnosis or screening of latent TB in these groups.

AFB smear and culture

For suspected active TB, ALL of the following tests meet coverage criteria:

Suspected TB core tests: a. Acid fast bacilli (AFB) smear/stain. b. Culture and culture-based drug susceptibility testing of Mycobacteria spp.

Policy states these tests MEET COVERAGE CRITERIA for suspected TB infections.

NAAT / Direct probe coverage

NAAT/Probe testing meets coverage criteria for any of the following organisms/tests:

NAAT/probe targets: a. Mycobacteria spp. b. M. tuberculosis. c. Qualitative nucleic acid amplification testing (NAAT) for Mycobacteria spp., M. tuberculosis, and M. avium intracellulare complex.

Direct probe or amplified probe nucleic acid-based testing MEETS COVERAGE CRITERIA.

Molecular-based drug susceptibility testing

Molecular-based drug susceptibility testing meets coverage criteria when ALL of the following apply:

Triggers for molecular DST: Applies when sputum is AFB smear positive or Hologic Amplified MTD NAAT positive AND one of: prior TB treatment; born in or 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 MDR-TB prevalence (≥2%); contact of an individual with MDR-TB; HIV infection.

Policy lists these specific conditions for coverage of molecular DST.

Repeat susceptibility testing

Repeat drug susceptibility testing meets coverage criteria when ANY of the following are present:

Repeat DST indications: a. For individuals whose sputum cultures remain positive after 3 months of treatment. b. When there is bacteriological reversion from negative to positive.

Policy explicitly permits repeat DST in these situations.

Body fluid analyses for extrapulmonary TB

Testing of body fluids meets coverage criteria when ALL of the following apply:

Fluid studies: 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.

These fluid analyses MEET COVERAGE CRITERIA for suspected extrapulmonary TB.

Urine LAM for HIV-infected patients

Urine LAM testing meets coverage criteria when ALL of the following are met:

LAM testing: HIV-infected individuals with CD4 cell counts ≤100 cells/microL who have signs and symptoms of tuberculosis.≤100 cells/microL

Policy supports urine LAM in this high-risk subgroup.

Not medically necessary / not covered tests

The following tests do NOT meet coverage criteria:

Not covered tests: Quantitative nucleic acid testing for Mycobacterium spp., M. tuberculosis, and M. avium intracellulare complex; whole genome sequencing of Mycobacterium spp. for the detection of drug resistance; genotyping of Mycobacterium spp.; testing of adenosine deaminase (ADA) and interferon-gamma (IFN-γ) levels in cerebrospinal, pleural, peritoneal, pericardial, and other fluids for diagnosis of extrapulmonary TB; testing of serum protein biomarkers or panels for the detection and diagnosis of TB.

Policy lists these as not meeting coverage criteria due to lack of sufficient evidence.

IGRA not covered for active TB

IGRA use for active tuberculosis

IGRA in active TB: For individuals with active tuberculosis, IGRA DOES NOT MEET COVERAGE CRITERIA.

Policy explicitly states IGRA is not covered for active TB.

The policy explicitly excludes several advanced or investigational laboratory methods from coverage. Quantitative nucleic acid testing for Mycobacterium spp., M. tuberculosis, and M. avium‑intracellulare complex DOES NOT MEET COVERAGE CRITERIA. Whole genome sequencing of Mycobacterium spp. for detection of drug resistance, genotyping of Mycobacterium spp., measurement of adenosine deaminase (ADA) and interferon‑gamma (IFN‑γ) levels in cerebrospinal, pleural, peritoneal, pericardial, and other body fluids for extrapulmonary TB diagnosis, and testing of serum protein biomarkers or biomarker panels for TB detection DO NOT MEET COVERAGE CRITERIA.

Coverage and payment for services described in this policy depend on the member’s plan benefits and eligibility on the date of service. Claims are adjudicated subject to member benefits, eligibility, coordination of benefits, referral/authorization, and utilization management requirements. An authorization, when required, is not a guarantee of payment. Providers should follow applicable coding and billing rules and be aware that the plan may perform audits and require refunds for noncompliant claims.

The policy lists specific advanced or investigational tests and provides the rationale that these items do not meet coverage criteria. Listed methods include quantitative NAAT for Mycobacterium spp., whole genome sequencing to detect drug resistance, genotyping of isolates, measurement of ADA and IFN‑γ in body fluids for extrapulmonary TB diagnosis, and serum protein biomarker panels for TB detection. These tests are identified as not meeting coverage criteria due to insufficient evidence of clinical benefit for routine coverage in the diagnosis or management of active or latent tuberculosis.

Procedure and Billing Codes

Procedure codes referencedmixed

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 in cell suspension.
87206	Smear, primary source with interpretation; fluorescent and/or acid-fast stain for bacteria, fungi, parasites, viruses or cell types.
87116	Culture, tubercle or other acid-fast bacilli (e.g., TB, AFB, mycobacteria) any source, with isolation and presumptive identification of isolates.
87070	Culture, bacterial; any other source except urine, blood or stool, aerobic, with isolation and presumptive identification of isolates.
87149	Culture, typing; identification by nucleic acid (DNA or RNA) probe, direct probe technique, per culture or isolate, each organism probed.
87550	Infectious agent detection by nucleic acid (DNA or RNA); Mycobacteria species, direct probe technique.
87551	Infectious agent detection by nucleic acid (DNA or RNA); Mycobacteria species, amplified probe technique.
87552	Infectious agent detection by nucleic acid (DNA or RNA); Mycobacteria species, quantification.
87555	Infectious agent detection by nucleic acid (DNA or RNA); Mycobacteria tuberculosis, direct probe technique.

1–10 of 30

1/3

Coding updates (added / removed)mixed

87564	code added to coding grid
0574U	code added to coding grid
87149	code removed from coding grid
87550	code removed from coding grid
87555	code removed from coding grid
87560	code removed from coding grid

inv-15: High TB incidence country threshold

High TB incidence country threshold≥20 per 100,000

Context for useApplied when considering molecular-based DST or when assessing TB risk related to country of birth/residence

Duration criterionApplies when individual was born in or has lived for at least 1 year in the country

inv-16: High primary MDR-TB prevalence threshold

High primary MDR-TB prevalence threshold≥2%

Context for useUsed as a trigger for molecular-based drug susceptibility testing when combined with smear/NAAT positivity

Provider Actions, Documentation, and Billing Guidance

Billing Rule

New molecular resistance code effective date

New CPT code 87564 (Mycobacterium tuberculosis, rifampin resistance, amplified probe technique) is effective for dates of service beginning June 1, 2026. Providers should be aware of the effective date and bill using the new code only for services on or after that date.

87564 — Infectious agent detection by nucleic acid (DNA or RNA); Mycobacterium tuberculosis, rifampin resistance, amplified probe technique (effective DOS ≥ 2026-06-01)

Prior Authorization

Authorization requirement

Prior authorization may be required for certain TB-related tests per member benefits and utilization management rules. Note that an authorization does not guarantee payment; claims remain subject to eligibility, benefits, medical necessity, and coding compliance.

Background and Scope

Mycobacterium tuberculosis infection produces a spectrum of clinical states ranging from asymptomatic latent infection to symptomatic pulmonary and extrapulmonary disease. Laboratory culture remains the diagnostic reference standard because it provides both organism identification and isolates for susceptibility testing. Molecular methods such as nucleic acid amplification tests (NAAT/PCR) improve sensitivity and enable more rapid detection of low‑density infections, while immune‑based assays (e.g., interferon‑gamma release assays) are used primarily to detect latent infection rather than to diagnose active disease.

Definitions

inv-27: IGRA definition — blood test measuring IFN-γ response to M. tuberculosis-specific antigens

DefinitionInterferon-gamma release assay (IGRA): a blood test measuring T‑cell release of interferon‑gamma following stimulation by M. tuberculosis‑specific antigens to detect latent tuberculosis infection.

Primary useScreening and diagnosis of latent TB infection (LTBI) in at‑risk individuals or where screening is required by law

LimitationsNot indicated for diagnosis of active tuberculosis per policy

inv-28: NAAT definition — nucleic acid amplification tests to detect mycobacterial DNA/RNA

DefinitionNucleic acid amplification test (NAAT): tests (e.g., PCR) used to detect and identify mycobacterial DNA/RNA, providing sensitive detection of active infection.

Applications

Policy Revision History

2025-09-01coding_update

Annual policy review removed CPT/HCPCS codes 87149, 87550, 87555, and 87560 and added CPT/HCPCS codes 87564 and 0574U to the coding grid.

2025-11-01policy_effectiveLatest

Policy created to support coverage guidelines, effective for dates of service beginning Nov. 1, 2025.

Policy Summary

Payerharvard pilgrim health care

PolicyLaboratory testing for diagnosis of active and latent tuberculosis

Policy CodePolicy N/A

Change TypeCoding updates and new policy entry

Effective DateNov 1, 2025

Next Review DateSep 1, 2026

Key ActionDocument clinical indication including risk factors, HIV status and CD4, prior TB treatment history, contact with MDR-TB, or residence in high-incidence/MDR-prevalence countries.

SourceLink

On This Page

Applies toCountries with high primary multidrug-resistant TB prevalence as defined in policy

inv-17: HIV CD4 threshold for LAM testing

HIV CD4 threshold for LAM testing≤100 cells/microL

IndicationUrine LAM testing meets coverage when HIV-infected individuals with CD4 ≤100 have signs or symptoms of TB

Target populationHIV-infected patients being evaluated for active TB

Obtain prior authorization where required by the member's plan.
Authorization does not guarantee payment; claims will be adjudicated based on benefits, eligibility, and medical necessity.

Note

Criteria for molecular-based drug susceptibility testing

Molecular-based drug susceptibility testing is covered when the individual's sputum is AFB smear positive or NAAT positive and there is a history of prior TB treatment or epidemiologic risk (born in or lived ≥1 year in a country with moderate/high TB or MDR-TB prevalence).

Covered when sputum is AFB smear positive or NAAT positive AND one of: prior TB treatment OR born in/lived ≥1 year in country with TB incidence ≥20/100,000 or MDR-TB prevalence ≥2%.

Documentation Required

Required clinical documentation

Document the clinical indication for testing, relevant HIV status/CD4 if applicable, prior TB treatment history, country of birth or residence when relevant, and any legal screening obligations. Maintain records to support medical necessity and coding.

Document clinical indication and test results (AFB smear, NAAT).
Document HIV status and CD4 count when relevant.
Document prior TB treatment history and relevant travel/residence history (country and duration).
Document any legally required screening.

Documentation Required

Documentation & audit note

Payment is contingent on member benefits, eligibility, medical necessity, provider network status, and correct coding. Claims may be audited and providers may be required to refund payments found to be noncompliant.

Claims payment depends on member eligibility and benefits on date of service.
Claims are subject to medical necessity review, utilization management, and claims editing logic.
Harvard Pilgrim Health Care reserves the right to audit and recoup payments for noncompliance.

Denial Risk

Potential denial triggers

Ordering overlapping or duplicative molecular/direct probe tests for the same specimen or clinical indication may result in claim denials. Ensure tests billed are distinct, medically necessary, and supported by documentation.

Simultaneous ordering of overlapping molecular/direct probe tests for the same purpose may trigger denials.
Quantitative NAAT and whole genome sequencing/genotyping are noted as not meeting coverage criteria and may be denied when billed inappropriately.

Denial Risk

Denial triggers

Claims are subject to verification of eligibility, benefits, prior authorization, and adherence to utilization management. Missing documentation, lack of prior authorization when required, or services not meeting coverage criteria may lead to denial.

Denials may occur for lack of member eligibility or benefits on the date of service.
Denials may occur when prior authorization is required but not obtained.
Denials may occur if services do not meet medical necessity or coverage criteria (e.g., quantitative NAAT, whole genome sequencing, genotyping listed as not covered).

Qualitative detection of Mycobacteria spp., M. tuberculosis, and M. avium intracellulare complex as listed in coverage criteria

FormatsIncludes direct probe and amplified probe nucleic acid‑based testing (PCR) per policy

inv-29: AFB smear/culture definition — methods for visualization and culture; culture gold standard

DefinitionAFB smear and culture: acid‑fast bacilli smear/stain for direct visualization and culture methods for growth‑based identification of mycobacteria; culture is the gold standard for diagnosis and provides isolates for susceptibility testing.

Role in suspected TBAFB smear and culture (including culture‑based DST) meet coverage criteria for all suspected TB infections

Diagnostic valueCulture is most sensitive and enables species identification and drug susceptibility testing

inv-30: NAAT / GeneXpert definition — rapid detection including some resistance markers

DefinitionNAAT / GeneXpert: rapid nucleic acid amplification tests for detection of Mycobacterium tuberculosis complex and some resistance markers (e.g., rifampin), including GeneXpert/MTB RIF assays.

Clinical utilityUsed for rapid detection of TB and to identify certain resistance markers to guide therapy

Supporting guidanceReferenced in CDC/WHO guidance and multiple evidence sources cited in policy

inv-31: Urine LAM definition — lateral flow assay for TB detection in urine with evidence for HIV-positive patients

DefinitionUrine LAM (lipoarabinomannan) assay: a lateral flow urine test for detection of TB antigen in urine with evidence supporting diagnostic accuracy in HIV‑positive patients.

Coverage indicationPolicy supports urine LAM testing for HIV‑infected individuals with CD4 ≤100 cells/microL who have signs or symptoms of TB

Evidence baseMultiple studies and systematic reviews (including Cochrane and STAMP trial) are cited supporting use in this high‑risk group