IGRA for latent TB
Covered when ANY of the following are met:
Individuals who are at risk for infection with Mycobacterium tuberculosis (Mtb).
Individuals who are unlikely to be infected with Mtb when screening is obliged by law.
Reimbursable tests for suspected TB infection
For all suspected TB infections, the following are reimbursable:
Acid fast bacilli (AFB) smear/stain.
Culture and culture-based drug susceptibility testing of Mycobacteria.
Qualitative nucleic acid amplification testing (NAAT) for Mycobacteria spp, M. tuberculosis and M. avium complex.
Molecular-based drug susceptibility testing
Molecular-based drug susceptibility testing may be reimbursed when ANY of the following are met:
The individual has been treated for TB in the past.
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%).
The individual is a contact of an individual with MDR-TB.
The individual is HIV infected.
Repeat drug susceptibility testing
Repeat drug susceptibility testing may be reimbursed when ANY of the following occur:
For individuals whose sputum cultures remain positive after 3 months of treatment.
When there is bacteriological reversion from negative to positive.
Extrapulmonary fluid testing
Fluid testing coverage for suspected 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 reimbursed.
Tests not meeting coverage
The following tests do not meet coverage criteria due to insufficient evidence:
Quantitative nucleic acid testing for Mycobacterium spp, M. tuberculosis, and M. avium complex may not be reimbursed.
Whole genome sequencing of Mycobacterium spp. for the detection of drug resistance may not be reimbursed.
Genotyping of Mycobacterium spp. may not be reimbursed.
Testing of adenosine deaminase (ADA) and interferon-gamma (IFN-γ) levels in cerebrospinal, pleural, peritoneal, pericardial, and other fluids for the diagnosis of extrapulmonary TB may not be reimbursed.
Testing of serum protein biomarkers or panels of biomarkers for the detection and diagnosis of TB may not be reimbursed.
Urine LAM testing in HIV
Covered when ALL of the following are met:
Individual is HIV-infected with CD4 cell count ≤ 100 cells/µL.
Individual has signs and symptoms of tuberculosis.
Urine-based detection of mycobacterial lipoarabinomannan (LAM) is intended to aid diagnosis in this clinical context.