CurrentBlue Cross Blue Shield - TennesseePolicy N/A

β‑Hemolytic Streptococcus Testing Coverage Criteria

Coverage criteria for laboratory testing to detect β-hemolytic Streptococcus (groups A, B, C, G and related assays) for diagnosis of pharyngitis, skin/soft tissue infections, bacteremia, and related conditions; applies to Blue Cross Blue Shield - Tennessee members.

Policy Summary

PayerBlue Cross Blue Shield - Tennessee

Policyβ‑Hemolytic Streptococcus Testing Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionDocument modified Centor score and clinical indication when ordering culture or blood testing; reserve testing for patients with Centor ≥3 or absence of viral features.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Centor ≥3Centor threshold

RADT not coveredRADT coverage

ASO/ADB for ARF/PSGNSerology permitted

Culture = gold standardCulture standard

NAAT ↑3.5xNAAT trend

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Coverage Criteria for β-Hemolytic Streptococcus Testing

Bacterial culture testing for respiratory illness (throat swab)

Covered when ANY of the following are met:

Throat culture coverage: a) Modified Centor criteria score of 3 or greater.Centor >=3

Per policy Indications and/or Limitations of Coverage; Centor definition: tonsillar exudates, tender anterior cervical lymphadenopathy, fever, absence of cough.

Throat culture coverage: b) Suspected bacterial pharyngitis in the absence of viral features (eg, cough, oral ulcers, rhinorrhea).

Reserve testing when viral features are absent per CDC/ICSI guidance.

Throat culture coverage: c) Following a negative rapid antigen diagnostic test (RADT) in a symptomatic child or adolescent.

Per CDC and pediatric guidance for RADT negative arbitration.

Blood culture testing for streptococcal infection

Covered when ANY of the following are met:

Blood culture coverage: a) Individuals who fail to demonstrate clinical improvement or who have progressive symptoms/clinical deterioration after initiation of antibiotic therapy.

Per policy Indications and/or Limitations of Coverage and PIDS-IDSA recommendations for children failing to improve.

Blood culture coverage: b) Cases of suspected prosthetic joint infection.

Per policy Indications and/or Limitations of Coverage; obtain cultures when prosthetic joint infection is suspected.

Skin and soft tissue infection culture

Covered when ALL of the following are met:

Skin/soft tissue culture: Bacterial culture testing from a skin swab or from pus for suspected streptococcal skin and soft tissue infection.

Coverage meets criteria when specimen is collected from the affected skin/soft tissue site.

Tests not meeting coverage criteria

The following tests do not meet coverage criteria:

Non-covered indications: a) Bacterial culture testing for streptococci from a throat swab in suspected viral pharyngitis.

Per Reimbursement Policy: does not meet coverage.

Non-covered indications: b) Rapid antigen diagnostic tests (RADT) for streptococcal infection when used as: (1) a follow-up to culture, (2) screening in asymptomatic patients, or (3) in cases of suspected viral pharyngitis (exception: asymptomatic children under age 3 with a mitigating circumstance).

Policy lists RADT non-coverage scenarios except stated pediatric exception.

Non-covered indications: c) Serological titer testing (eg, ASO) except when suspected acute rheumatic fever (ARF) or post-streptococcal glomerulonephritis (PSGN) is present.

Per Reimbursement Policy exclusions.

When to test for GAS pharyngitis

Testing is appropriate when clinical suspicion for GAS is high and when results will influence treatment decisions.

Primary testing criteria: Patient has signs and symptoms consistent with GAS pharyngitis (eg, acute onset sore throat, fever, tonsillar exudate, tender anterior cervical lymphadenopathy) AND absence of viral features (eg, cough, rhinorrhea, hoarseness, oral ulcers, conjunctivitis).Centor/McIsaac score >=3 preferred

ICSI consensus: do not test when modified Centor <3 or viral features present; reserve testing for patients with high suspicion and intent to treat.

Pediatric testing and reflex strategy

Guidance specific to children

Pediatric approach: Children with high clinical suspicion should receive a rapid antigen test; if the rapid antigen test is negative but clinical suspicion remains, obtain a throat culture or perform a more sensitive NAAT (eg, PCR) before withholding antibiotics.

AAP/CDC recommend culture or NAAT backup for negative RADT in children; dual swab strategy may be used.

Pediatric testing limitations: Do not routinely test children younger than 3 years or children with clear viral symptoms; testing may be considered for asymptomatic children <3 only with mitigating circumstances such as a symptomatic household contact.

Per AAP and CDC guidance.

Intrapartum GBS testing

Use of PCR-based testing for Group B Streptococcus during labor

Intrapartum PCR use: PCR-based intrapartum GBS assays may be used to direct intrapartum antibiotic prophylaxis because of high sensitivity and rapid turnaround, improving negative predictive value compared with prenatal culture in preliminary studies.

Policy cites Helmig & Gertsen and other preliminary studies supporting intrapartum PCR utility; larger studies recommended.

Indications and testing pathways

Testing for streptococcal pharyngitis is considered appropriate when clinical and testing conditions indicate a high likelihood or require confirmation for treatment decisions.

Appropriate testing for GAS pharyngitis: Provider documents a modified Centor score >=3 OR high clinical suspicion for GAS based on age and exam findings, and the intent is to treat with antibiotics.Centor >= 3

ICSI recommends reserving testing for patients with high pretest probability and intention to treat.

Pediatric negative antigen pathway: If a pediatric patient has a negative direct antigen test and the antigen test sensitivity is known to be <80%, a second throat swab should be tested by direct NAAT or by culture to arbitrate a possible false-negative result.antigen sensitivity <80%

IDSA/PIDS pediatric guidance; secondary testing not always required in adults.

Use of NAATs:

CAP culture recommendations

Sputum and blood culture testing in pneumonia

Outpatient adult CAP: Do not routinely obtain sputum Gram stain/culture or blood cultures in adults managed as outpatients with community-acquired pneumonia.outpatient CAP

ATS/IDSA strong recommendation against routine outpatient sputum and blood cultures.

Pediatric and hospitalized CAP: Obtain blood cultures in hospitalized children with moderate–severe presumed bacterial CAP or in children who fail to improve or deteriorate after antibiotics; obtain sputum Gram stain/culture in hospitalized children who can produce sputum.hospitalized pediatric CAP

PIDS–IDSA recommendations for cultures in hospitalized pediatric CAP or deteriorating patients.

Panel and multiplex assays that simultaneously screen for multiple beta-hemolytic streptococcal groups are excluded from coverage. Examples specifically listed include the Solana Strep Complete Assay and the Lyra Direct Strep Assay. The policy also identifies broad platform approaches used to detect or speciate streptococci (for example, MALDI-TOF identification) as tests that do not meet coverage criteria due to insufficient published evidence of clinical benefit.

Testing for group A streptococcal (GAS) pharyngitis is not routinely indicated in settings with a low pretest probability. Public health and pediatric guidance note that most acute pharyngitis is viral and that patients with clear viral features (e.g., cough, rhinorrhea, hoarseness, oral ulcers, conjunctivitis) generally do not require testing. Similarly, testing is generally not recommended for children younger than 3 years unless specific mitigating circumstances (such as a symptomatic household contact) exist.

NICE reviewed rapid tests for Group A streptococcus and concluded that routine adoption is not recommended for people with sore throat because the tests are unlikely to meaningfully improve antimicrobial prescribing, stewardship, or patient outcomes compared with clinical scoring alone.

Selected references supporting diagnostic and management statements include: J Clin Microbiol. 'Streptococcus from Pharyngeal Specimens' (2016) DOI:10.1128/jcm.02405-15, and key reviews on Group B Streptococcus management and intrapartum screening (Puopolo et al., Pediatrics 2019; related reviews and observational studies cited in the policy bibliography).

Rapid antigen detection testing (RADT) is specified as not meeting coverage criteria when used as a follow-up to culture, as screening in asymptomatic patients, or in cases of suspected viral pharyngitis (with limited exceptions for certain asymptomatic children under age three with mitigating circumstances).

Routine testing is discouraged when the clinical presentation indicates low likelihood of GAS — for example, when the modified Centor (or McIsaac) score is less than 3 or when exam/history clearly indicate a viral etiology. In children, guidelines state that those with obvious viral symptoms should not be tested or treated for GAS.

The ICSI guideline consensus is explicit: do not test for GAS pharyngitis when the modified Centor score is less than 3 or when viral features (rhinorrhea, cough, oral ulcers, hoarseness) are present. Testing should be reserved for patients with high clinical suspicion and intent to treat with antibiotics.

No additional explicit 'not medically necessary' statements are contained in the policy reference list entries themselves; those chunks comprise bibliographic citations supporting the clinical and diagnostic guidance elsewhere in the policy.

Coding, Scores, and Test Listings

No explicit CPT/ICD/NDC/HCPCS codes in this sectionmixed

No codes listed

FDA-cleared assays and LDT notemixed

No codes listed

inv-20: Modified Centor score threshold — >= 3 (testing threshold)

Modified Centor score threshold>= 3

Context for useUsed to determine when throat culture testing for GAS pharyngitis meets coverage criteria

Documentation requirementProvider should document the modified Centor score in the medical record when ordering testing

inv-21: Modified Centor score guidance — < 3 testing not recommended

Recommendation for low scoresModified Centor score < 3 — testing not recommended

RationaleICSI consensus: do not test patients with modified Centor <3 or with viral features (rhinorrhea, cough, oral ulcers, hoarseness)

Provider Actions, Documentation, and Prior Authorization Notes

Prior Authorization

Prior authorization guidance for GAS testing

Prior authorization: Reserve testing for GAS when clinical suspicion is high (e.g., modified Centor/McIsaac score ≥ 3) or when viral features (cough, rhinorrhea, hoarseness, oral ulcers, conjunctivitis) are absent. Do not routinely test children <3 years or patients with clear viral symptoms. In pediatric patients, a negative RADT from a test known to have sensitivity <80% should be followed by culture or a sensitive NAAT.

Testing indicated when modified Centor ≥ 3
Do not test when viral features present
Avoid routine testing in children <3 years unless mitigating circumstances

Note

Prior authorization / regulatory note

Regulatory note: Multiple FDA-cleared NAATs exist for GAS (e.g., Lyra Direct Strep, Solana Strep Complete, GenePOC Strep A, Accula Strep A). Many laboratories also use validated laboratory-developed tests (LDTs) regulated under CLIA; FDA clearance is not required for clinical use of LDTs.

Background and Rationale

Group A Streptococcus (GAS) is the most common bacterial cause of acute pharyngitis and can lead to important complications such as scarlet fever, acute rheumatic fever (ARF), and post-streptococcal glomerulonephritis (PSGN). Epidemiologic data indicate that most sore throats are viral (CDC: only ~20–30% in children and 5–15% in adults are GAS). Clinical risk stratification using Centor/modified Centor criteria (tonsillar exudates, tender anterior cervical lymphadenopathy, fever, absence of cough, with age adjustment in the modified score) helps identify patients in whom testing is appropriate; a score of 3 generally argues against testing per ICSI guidance. When testing is performed, throat culture remains the diagnostic gold standard, and RADT or NAAT may be used according to age and local testing algorithms.

Definitions and Abbreviations

inv-40: Centor criteria — components and usage

ComponentsTonsillar exudates; tender anterior cervical lymphadenopathy; fever; absence of cough — each counts as one point

PurposeUsed to gauge likelihood of GAS pharyngitis and guide testing decisions

Scoring implicationPatients scoring >=3 can be tested for GAS pharyngitis; those scoring <3 are unlikely to have GAS

inv-41: GAS / GBS / GCS / GGS abbreviations

GASGroup A Streptococcus

GBSGroup B Streptococcus

GCS

Revision History and References

2017-01-01guideline_informed_update

Institute for Clinical Systems Improvement (ICSI) 2017 guidance incorporated to emphasize reserving testing for patients with modified Centor score >=3 and avoiding testing when viral features are present.

2019-12-01literature_addition

Added citation for Puopolo et al. (2019) on management of infants at risk for Group B Streptococcal disease to support GBS-related guidance.

2022-06-27bibliography_update

Policy Summary

PayerBlue Cross Blue Shield - Tennessee

Policyβ‑Hemolytic Streptococcus Testing Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionDocument modified Centor score and clinical indication when ordering culture or blood testing; reserve testing for patients with Centor ≥3 or absence of viral features.

SourceLink

On This Page

Non-covered indications:

d) Simultaneous coding for both amplification and direct probe methods.

Policy states this dual coding does not meet coverage criteria.

Non-covered indications: e) Specific tests and panels lacking evidence, including panel assays that screen/identify multiple streptococcal strains (eg, Solana Strep Complete, Lyra Direct Strep Assay), MALDI-TOF identification of streptococcus, nucleic acid quantification of streptococcal strains, and hyaluronidase/streptokinase/NADase activity assays.

Listed in policy as not meeting coverage due to lack of supporting literature.

Direct and amplified NAATs are acceptable and are more sensitive than direct antigen tests; negative direct NAAT results do not require secondary arbitration.

Per policy statements on NAAT sensitivity and arbitration.

ImplicationRoutine testing in low pretest probability cases is discouraged as it is unlikely to change management

FDA-cleared assays: Lyra Direct Strep Assay, Solana Strep Complete Assay, GenePOC Strep A, Accula™ Strep A Test

LDTs are CLIA-regulated high-complexity tests and may be used clinically

Prior Authorization

Indications for testing

Indications for testing: Use history and exam to avoid testing when viral pharyngitis is likely. Confirm GAS pharyngitis with RADT or throat culture when clinical features suggest GAS. Reserve testing for patients for whom a positive result would change management (intention to treat with antibiotics).

Do not test patients with clear viral symptoms (cough, rhinorrhea, hoarseness, oral ulcers, conjunctivitis)
Test when clinical presentation (e.g., fever, tonsillar exudate, tender anterior cervical lymphadenopathy, absence of cough) yields high pretest probability
Testing not routinely indicated in adults and children <3 years

Documentation Required

Required Clinical Documentation

Required clinical documentation: Document the modified Centor (or McIsaac) score and the presence or absence of viral features; record symptoms, age, and whether testing will alter management. For RADT/NAAT/culture orders, include clinical rationale and relevant exam findings in the record.

Record modified Centor/McIsaac score (list components)
Note specific symptoms (fever, tonsillar exudate, tender anterior cervical adenopathy, cough absence, rhinorrhea, hoarseness, oral ulcers)
Document intention to treat with antibiotics if positive

Documentation Required

Documentation for ARF

Documentation for suspected acute rheumatic fever (ARF): Laboratory evidence of preceding GAS infection is required — rising or increased anti-streptolysin O (ASO) or anti-DNase B titers (rise preferred), a positive throat culture, or a positive rapid antigen test in a child with high pretest probability. Include relevant Jones criteria findings and epidemiologic risk in the record.

Prefer a rise in ASO or anti-DNase B titers over a single titer
Positive throat culture or positive RADT in high-probability pediatric cases can support prior GAS infection
Document Jones criteria assessment and epidemiologic risk level

Step Therapy

Pediatric Testing Algorithm

Pediatric testing algorithm: For children with suspected GAS pharyngitis, perform RADT at point of care. If RADT is positive, treat — no culture confirmation required. If RADT is negative and the RADT sensitivity is known to be <80%, obtain a second swab for throat culture or perform a sensitive NAAT. Consider dual swab collection initially to facilitate reflex testing.

Positive RADT in children: treat — throat culture not required
Negative RADT with sensitivity <80%: reflex to culture or sensitive NAAT from a second swab
Consider collecting dual swabs at initial visit to enable reflex testing without repeat sampling

Prior Authorization

Culture step approach in CAP

Culture step approach in community-acquired pneumonia (CAP): Do not obtain routine sputum Gram stain/culture or blood cultures in adults with outpatient CAP. Obtain blood cultures or sputum cultures in severe, hospitalized, complicated, or deteriorating cases, or when patients fail to improve after appropriate therapy.

No routine sputum Gram stain/culture or blood cultures for adults with outpatient CAP
Obtain blood cultures in hospitalized or clinically deteriorating patients
In children with CAP: avoid routine blood cultures in non-toxic, fully immunized outpatients; obtain cultures if clinical deterioration or hospitalization occurs

Group C Streptococcus

GGSGroup G Streptococcus

inv-42: RIDT / RADT definition — rapid antigen detection tests, CLIA-waived, variable sensitivity

DefinitionRapid in vitro diagnostic / rapid antigen detection tests (RIDT/RADT) for GAS — CLIA‑waived point‑of‑care assays providing quick results

Performance noteSensitivity varies by manufacturer, method, and patient population

Clinical roleOften used for initial testing, especially in pediatrics, but may require culture/NAAT backup when sensitivity is low

inv-43: NAAT / RNAT / HDA — nucleic acid amplification test definitions

DefinitionNucleic acid amplification tests (NAAT) — molecular methods (e.g., PCR, isothermal HDA) that detect streptococcal nucleic acids

IncludesReal‑time PCR assays and isothermal amplification methods such as helicase‑dependent amplification (HDA)

Clinical advantageGenerally more sensitive than rapid antigen tests and increasingly used in clinical labs

inv-44: Modified Centor criteria summary — includes age, physical findings, fever, cough absence

Core elementsModified Centor criteria include patient age, tonsillar/lymph node physical findings, temperature (fever), and absence of cough

UseApplied to risk‑stratify likelihood of GAS pharyngitis and guide testing/treatment decisions

InterpretationScore >=3 supports testing; score <3 suggests testing not indicated

inv-45: NAAT definition — molecular assays more sensitive than RADT

DefinitionNAAT — molecular assays (e.g., real‑time PCR) for detection of streptococcal nucleic acids from throat swabs

Clinical noteFDA has approved multiple NAATs for GAS/GCS/GGS detection (e.g., Lyra Direct Strep Assay, Solana, GenePOC, Accula)

PerformanceNAATs are generally more sensitive than rapid antigen tests

inv-46: Rapid antigen detection tests and molecular NAATs for Group A, C, G Streptococcus — general note

ScopeRapid antigen detection tests and molecular NAATs are available for detection of Group A, C, and G Streptococcus from throat swabs

Operational differencesRADTs are CLIA‑waived, point‑of‑care assays with variable sensitivity; NAATs (including HDA) are molecular assays with higher sensitivity and FDA clearances for various platforms

Clinical applicationDirect and amplified NAATs acceptable as primary tests; negative RADT in children may require reflex culture or NAAT depending on antigen sensitivity

CDC (2022) guidance on post-streptococcal glomerulonephritis added to reference list to support serology and complication guidance.