β - Hemolytic Streptococcus Testing
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Defines coverage and non-coverage criteria for laboratory testing to detect β-hemolytic streptococcal infections (throat, blood, skin/soft tissue, serology) including RADT, culture, NAATs, and specific serologic assays; applies per member benefits and notes Medicare/Medicaid specifications are elsewhere.
No material clinical or coverage changes
Coverage Summary
Scope: Defines coverage and non-coverage criteria for laboratory testing to detect β-hemolytic streptococcal infections (throat, blood, skin/soft tissue, and serology) including RADT, culture, NAATs, MALDI-TOF, and specific serologic assays; application depends on the individual's benefit coverage and applicable Medicare/Medicaid specifications.
Overview of coverage stance: Coverage is mixed — throat culture, blood culture, skin/pus culture, NAAT or RADT (with specified exceptions), and serologic testing for suspected post-infectious complications meet coverage when medical necessity criteria are met; multiple tests and modalities are explicitly not covered or considered investigational in other situations.
Thresholds summary: use the modified Centor criteria score >= 3 (or clinical suspicion of bacterial pharyngitis without viral features) to justify throat swab culture; routine testing generally not indicated in children < 3 years except in special circumstances. Benefit verification and Medicare/Medicaid specifications apply and must be checked before ordering.
Medical-Necessity Criteria
Covered when MEDICAL NECESSITY criteria are met
Bacterial culture, blood culture, skin/pus culture, NAAT or RADT (per exceptions), and serologic testing meet coverage when following conditions are met:
ANY of the following
When culture meets criteria
- Individual has a modified Centor criteria score of 3 or greater
- Individual is suspected of having bacterial pharyngitis in the absence of viral features (e.g., cough, oral ulcers, rhinorrhea)
- Following a negative rapid antigen diagnostic test (RADT) in a symptomatic child or adolescent
ALL of the following
- Individuals who fail to demonstrate clinical improvement
- Individuals who have progressive symptoms or clinical deterioration after the initiation of antibiotic therapy
- Cases of suspected prosthetic joint infection
ALL of the following
- Indication: cases of skin and/or soft tissue infections
ANY of the following
- Serological titer testing for individuals with suspected acute rheumatic fever (ARF) or post-streptococcal glomerulonephritis (PSGN)
- Anti-streptolysin O (ASO) immunoassay
- Hyaluronidase activity or anti-hyaluronidase immunoassay
- Streptokinase activity or anti-streptokinase immunoassay
Not covered / Does not meet coverage criteria
Tests and situations specifically listed as not meeting coverage criteria
ANY of the following
- Bacterial culture testing from a throat swab for suspected viral pharyngitis
If viral features (e.g., cough, rhinorrhea, hoarseness, oral ulcers, conjunctivitis) are present
ANY of the following
- As a follow-up test for individuals who have had either a bacterial culture test or a nucleic acid test for a streptococcal infection
- As a screening method in an asymptomatic patient
- For individuals with suspected viral pharyngitis
- Serological titer testing for all situations not described as covered
Serological titers generally do not meet coverage except for suspected ARF or PSGN as specified
- Simultaneous ordering of both direct probe and amplification probe for the same organism in a single encounter
ANY of the following
- Anti-streptolysin O immunoassay, hyaluronidase activity or anti-hyaluronidase immunoassay, streptokinase activity or anti-streptokinase immunoassay for all situations not described above
- Panel tests that screen and identify multiple streptococcal strains using immunoassay or nucleic acid-based assays (e.g., Solana Strep Complete Assay, Lyra Direct Strep Assay)
- MALDI-TOF identification of streptococcus
- Quantification of any strain of streptococcus using nucleic acid amplification, including PCR
- Nicotinamide-adenine dinucleotide activity or anti-nicotinamide-adenine immunoassay
Testing indications for Group A Streptococcus (GAS) pharyngitis
Testing recommended when clinical presentation suggests high pretest probability; not recommended with viral features or in children <3 years except special circumstances:
ALL of the following
DO NOT test when ANY of the following viral features present
- rhinorrhea
- cough
- hoarseness
- oral ulcers
- conjunctivitis
- anterior stomatitis
- discrete ulcerative oral lesions
- diarrhea
- Children younger than 3 years: testing generally not indicated (except in outbreaks or high-risk contacts)
Test when ANY of the following increase likelihood
- acute onset sore throat with pharyngeal exudate
- pain on swallowing
- fever
- enlarged tender anterior cervical lymph nodes
- exposure to a person with GAS pharyngitis
Preferred testing approach
- Rapid antigen test performed; if positive, treat (no culture confirmation required due to high specificity)
- If rapid antigen negative in children AND rapid test sensitivity <80%: obtain throat culture or a more sensitive NAAT
- Direct or amplified NAATs are more sensitive; negative NAATs do not require secondary arbitration
- Testing asymptomatic household contacts: not recommended except if contacts are at increased risk of sequelae (eg, ARF) or in multiple household members with infections
Laboratory confirmation for Acute Rheumatic Fever (ARF)
Laboratory evidence should be confirmed in suspected ARF cases:
ANY of the following
- Increased or rising anti-streptolysin O (ASO) titer or anti-DNase B titer (rise better evidence than single titer)
Rise in titer is better evidence than single titer
- Positive throat culture for Group A β-hemolytic streptococci
- Positive rapid group A streptococcal carbohydrate antigen test in child with high pretest probability
Group B Streptococcus (GBS) testing in pregnancy and neonates
Screening and diagnosis recommendations for GBS:
ALL of the following
- Antepartum screening timing: Antepartum screening for GBS at 36 0/7–37 6/7 weeks for all pregnant women unless intrapartum prophylaxis already indicated (ACOG)
- Early-onset GBS infection diagnosed by blood or CSF culture; routine lab tests like CBC and CRP perform poorly in well-appearing infants
- Late-onset GBS diagnosis based on isolation of GBS from blood, CSF, or other sterile sites; adequate intrapartum antibiotic prophylaxis does not protect against late-onset disease
- Nucleic acid amplification-based identification from enrichment broth acceptable but not sufficient for all patients; perform antimicrobial susceptibility testing for GBS isolates from pregnant women with penicillin allergy
Nucleic acid amplification-based identification from enrichment broth acceptable but not sufficient for all patients; perform antimicrobial susceptibility testing for GBS isolates from pregnant women with penicillin allergy
Cultures and testing for skin/soft tissue and invasive infections
When to obtain cultures for non-pharyngeal infections:
ANY of the following
- Gram stain and culture of pus/exudate recommended to identify S. aureus and/or β-hemolytic Streptococcus for impetigo/ecthyma, carbuncles, abscesses, pyomyositis (IDSA)
- Cultures of blood and focal sites indicated in suspected invasive GAS infections
- Blood cultures not routinely recommended in outpatient CAP; consider in hospitalized, moderate to severe, or deteriorating patients (ATS/IDSA/PIDS guidance)
- Cultures of blood recommended in erysipelas/cellulitis for select high-risk patients (malignancy on chemo, neutropenia, severe immunodeficiency, immersion injuries, animal bites)
Use of rapid tests and NAATs
Test performance and operational recommendations:
ALL of the following
- Rapid antigen tests: high specificity, variable sensitivity; positive result generally does not require culture confirmation
- Direct NAATs and amplified NAATs are more sensitive than antigen tests; some rapid NAATs may be as sensitive as culture
- Home use of FDA-cleared rapid tests discouraged due to false-positive colonization risk (AAP)
- For Groups C and G: NAAT may be performed or throat culture with antigen testing on isolates; only large colony types identified
- Laboratory-developed tests (LDTs) are regulated under CLIA as high-complexity tests and are not FDA-cleared but may be used clinically
Coding
| 86060 | Antistreptolysin O; titer |
| 86063 | Antistreptolysin O; screen |
| 86215 | Deoxyribonuclease, antibody |
| 86317 | Immunoassay for infectious agent antibody, quantitative, not otherwise specified |
| 86318 | Immunoassay for infectious agent antibody(ies), qualitative or semiquantitative, single step-method (eg, reagent strip) |
| 87040 | Culture, bacterial; blood, aerobic, 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 |
| 87071 | Culture, bacterial; quantitative, aerobic with isolation and presumptive identification of isolates, any source except urine, blood or stool |
| 87077 | Culture, bacterial; aerobic isolate, additional methods required for definitive identification, each isolate |
| 87081 | Culture, presumptive, pathogenic organisms, screening only |
| 86060 | Antistreptolysin O; titer |
| 86063 | Antistreptolysin O; screen |
| 86215 | Deoxyribonuclease, antibody |
| 86317 | Immunoassay for infectious agent antibody, quantitative, not otherwise specified |
| 86318 | Immunoassay for infectious agent antibody(ies), qualitative or semiquantitative, single step-method (eg, reagent strip) |
| 87040 | Culture, bacterial; blood, aerobic, 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 |
| 87071 | Culture, bacterial; quantitative, aerobic with isolation and presumptive identification of isolates, any source except urine, blood or stool |
| 87077 | Culture, bacterial; aerobic isolate, additional methods required for definitive identification, each isolate |
| 87081 | Culture, presumptive, pathogenic organisms, screening only |
Provider Actions
Apply Centor criteria to justify throat culture
Document modified Centor criteria score (tonsillar exudates, tender anterior cervical lymphadenopathy, fever, absence of cough) and clinical features to support throat swab culture when score >= 3 or when bacterial pharyngitis suspected without viral features. Note: document the modified Centor score used when ordering/testing.
Benefit verification required
Application of coverage criteria depends on the individual's benefit coverage at time of request; verify member benefits and applicable Medicare and Medicaid specifications per the policy's state and federal regulations section.
Do not order simultaneous direct probe and amplification probe
Simultaneous ordering of both direct probe and amplification probe for the same organism in a single encounter does not meet coverage and may be denied.
RADT and serology use limitations
RADT ordered as a follow-up to culture/NAAT, for asymptomatic screening, or for suspected viral pharyngitis, and serological titers not indicated by ARF/PSGN criteria may be denied.
Document clinical features when ordering GAS testing
Providers should document presence of clinical signs (e.g., fever, pharyngeal exudate, tender anterior cervical lymphadenopathy, absence of viral features such as cough or rhinorrhea) or exposure history to justify GAS testing and potential treatment.
None specified in this part
No explicit prior authorization requirements are listed in this portion of the policy.
Confirmatory testing when indicated
If rapid antigen test sensitivity is <80% in pediatric patients and the rapid antigen is negative, perform secondary testing by throat culture or a more sensitive NAAT and document the rationale for confirmatory testing.
Testing in low pretest probability or viral presentations may be denied
Testing patients with viral features or a modified Centor score <3 may be considered unnecessary and could be denied; avoid testing in these low pretest probability situations unless exceptions apply (e.g., outbreaks, high-risk contacts, or intention to treat).
Background and Clinical Context
Clinical background: β-hemolytic streptococci include Group A (GAS, S. pyogenes), Group B (GBS, S. agalactiae), and Groups C/G (GCS/GGS, S. dysgalactiae subsp. equisimilis). These organisms cause pharyngitis, scarlet fever, acute rheumatic fever (ARF), post-streptococcal glomerulonephritis (PSGN), skin and soft tissue infections, invasive disease (bacteremia, sepsis, meningitis), and neonatal GBS disease.
Testing modalities: Bacterial culture (throat, blood, skin/pus) is considered the traditional gold standard for many specimen types; RADT (rapid antigen diagnostic tests) are point-of-care antigen assays; NAATs (direct/amplified nucleic acid amplification tests, including rapid molecular POC NAATs) detect streptococcal DNA/RNA; MALDI-TOF identifies organisms from pure cultures; and serology (ASO, anti-DNase B and other antistreptococcal antibodies) assesses prior/antecedent infection.
Performance characteristics and guidelines: Throat culture is the CDC gold standard; RADTs have high specificity but variable sensitivity (meta-analyses report summary sensitivities ~82-86%), so in children a negative RADT often requires backup culture or NAAT when RADT sensitivity <80%. NAATs and rapid nucleic acid tests are more sensitive (reported sensitivities up to ~97.5-98% and some NAATs approach culture performance) and negative NAATs generally do not require secondary arbitration. Multiple FDA-cleared NAATs (Lyra, Solana, GenePOC/Revogene, Accula) have high reported sensitivity and specificity; some HDA-based assays report sensitivity and specificity ~98% and rapid turnaround. MALDI-TOF is useful for rapid identification from isolates but may be inconclusive for less common organisms and is listed among tests not meeting coverage when used for streptococcus identification in certain contexts. Serologic titers (ASO, anti-DNase B) are useful to document antecedent GAS infection and are recommended for suspected ARF or PSGN, with rising titers (acute to convalescent) more informative than single measurements.
Definitions
Centor criteria: Four clinical items — tonsillar exudates, tender anterior cervical lymphadenopathy, fever, and absence of cough — each count one point; a modified Centor (McIsaac) score <3 makes GAS unlikely and testing is generally not required, while a score ≥3 supports testing for GAS pharyngitis.
LDT (Laboratory-Developed Test): A test developed and validated in-house; LDTs are regulated by CMS under CLIA as high-complexity tests, are not FDA-cleared, but may be used clinically following laboratory validation.
ASO / anti-DNase B: Serologic assays measuring antistreptococcal antibodies used as evidence of antecedent GAS infection; a rise in titer between acute and convalescent specimens is better evidence than a single titer; ASO typically peaks ~3–5 weeks after infection and anti-DNase B peaks later (6–8 weeks), and combined testing increases sensitivity/specificity for post-infectious complications.
Revision History
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