CurrentBlue Cross Blue Shield - TennesseePolicy N/A

β-Hemolytic Streptococcus Testing (Coverage Criteria)

Coverage criteria for laboratory testing to detect β-hemolytic Streptococcus (including Group A, B, C, and G) across specimen types and diagnostic modalities; governs medical necessity determinations for 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 change

Effective DateN/A

Next Review DateN/A

Key ActionConfirm benefit coverage and prior authorization requirements before ordering multiplex or excluded streptococcal assays.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Centor ≥3Throat culture threshold

Not coveredRADT stance

ExcludedMultiplex panels

97.5%RNAT sensitivity

29Procedure codes

multiple

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Coverage Criteria for β-Hemolytic Streptococcus Testing

Evidence and Regulatory Support

Evidence and regulatory sources that inform the policy (no explicit numeric coverage criteria in these excerpts):

Major public health guidance: CDC guidance indicates most acute pharyngitis is viral; testing for GAS is confirmed by RADT or throat culture, not routinely indicated for children <3 years, and carriers usually do not require treatment (CDC, 2022b, 2022c, 2022d).

Clinical practice guidelines: IDSA clinical practice guideline (Shulman et al., 2012) and AAP Red Book (Kimberlin et al., 2021) support use of RADT or culture to confirm GAS, recommend against routine testing in children with obvious viral features, and note that positive RADT generally does not require culture confirmation due to high specificity.

Systematic reviews and diagnostic accuracy studies: Meta-analyses and studies report higher sensitivity for molecular NAAT/RNAT/RNATs versus RADTs (Dubois et al., 2021; Cohen et al., 2015, 2016; Uphoff et al., 2016; Church et al., 2018). Rapid molecular methods approach culture sensitivity and may be suitable as standalone diagnostic tests in some settings.

Economic and implementation evidence: Cost-effectiveness analyses suggest point-of-care NAAT may be less costly and more effective than RADT plus culture, improving appropriate treatment and reducing unnecessary antibiotics (Bilir et al., 2021).

Regulatory status: Multiple rapid antigen and nucleic acid amplification tests for GAS have FDA clearance/510(k) summaries and device classifications supporting their clinical use; specific devices and clearances are cited (FDA 2016, 2019, 2020).

Professional society recommendations for respiratory and pneumonia management: ICSI recommends not testing patients with modified Centor <3 or with viral features (Short et al., 2017). ATS/IDSA and PIDS-IDSA guidance recommend against routine sputum and blood cultures and routine blood cultures in outpatients with CAP, reserving cultures for deteriorating or hospitalized patients (Metlay et al., 2019; Bradley et al., 2011).

Limitations of serology: Serologic tests (ASO, anti-DNase B) reflect prior infection and are useful for diagnosing post-infectious complications (e.g., ARF, PSGN) when acute testing is insufficient; rising titers between acute and convalescent samples provide best evidence of antecedent infection (Steer & Gibofsky, 2022; Steer et al., 2015).

Health technology assessments: NICE concludes rapid tests for strep A are not recommended for routine adoption for people with sore throat because incremental benefit over clinical scoring tools is limited (NICE, 2019).

Operational note: Taken together, these evidence and regulatory sources support the policy's emphasis on guideline-aligned, targeted diagnostic testing (use of Centor/McIsaac scoring, selective use of RADT/NAAT/culture, and reserving serology for post-infectious complications), and inform exclusions for panel tests, routine serology, and simultaneous redundant testing.

Procedure Codes, Scoring, and Key Coding Notes

Applicable CPT/HCPCS Procedure Codesmixed

No codes listed

Covered/Listed Procedure Codes (part 1)CPT

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
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

1–10 of 11

1/2

Covered/Listed Procedure Codes (part 2)CPT

87650	Infectious agent detection by nucleic acid (DNA or RNA); Streptococcus, group A, direct probe technique
87651	Infectious agent detection by nucleic acid (DNA or RNA); Streptococcus, group A, amplified probe technique
87652	Infectious agent detection by nucleic acid (DNA or RNA); Streptococcus, group A, quantification
87797	Infectious agent detection by nucleic acid (DNA or RNA), not otherwise specified; direct probe technique, each organism
87798	Infectious agent detection by nucleic acid (DNA or RNA), not otherwise specified; amplified probe technique, each organism
87799	Infectious agent detection by nucleic acid (DNA or RNA), not otherwise specified; quantification, each organism
87880	Infectious agent antigen detection by immunoassay with direct optical observation; Streptococcus, group A

FDA device identifiers and summariesmixed

No codes listed

Centor criteria score — threshold for testing

Threshold>= 3 (Centor criteria) — patients scoring 3 or greater can be tested for GAS pharyngitis

Centor componentsTonsillar exudates; tender anterior cervical lymphadenopathy; fever; absence of cough (1 point each)

Testing implicationPatients scoring <3 are unlikely to have GAS pharyngitis and do not require strep testing or antibiotics

Modified Centor score — testing guidance

Guideline-based thresholdModified Centor score ≥3 — testing generally reserved when score ≥3

Components

Provider Actions, Documentation, and Authorization

Prior Authorization

Confirm coverage before ordering

Confirm coverage with the payer before ordering tests listed as not meeting coverage criteria or when using multiplex/panel strategies or procedure codes that may require prior authorization. Benefit-specific rules (Medicare/Medicaid) and payer prior authorization requirements may apply.

Confirm coverage for tests listed as NOT MEETING COVERAGE CRITERIA (e.g., panel tests, MALDI-TOF identification, quantitative NAAT) before ordering.
Verify payer-specific prior authorization rules for CPT/HCPCS codes in the procedure code list (see Procedure codes requiring payer confirmation).

Denial Risk

Testing reserved for high pretest probability

Reserve testing for patients with high pretest probability of GAS infection (for example, modified Centor/McIsaac score ≥3) or when absence of viral features is documented. Do not routinely test children <3 years or patients with clear viral features.

Background and Clinical Context

Group A Streptococcus (GAS) is the most common bacterial cause of acute pharyngitis and is associated with complications such as acute rheumatic fever (ARF) and post-streptococcal glomerulonephritis (PSGN). Most cases of acute pharyngitis are viral; only a minority are GAS, and clinical assessment (Centor/McIsaac criteria) helps determine when testing is appropriate.

Definitions and Test Descriptions

Key terminology and abbreviations

GASGroup A Streptococcus (Streptococcus pyogenes)

GBSGroup B Streptococcus

GCS/GGSGroup C and Group G β-hemolytic streptococci

RADTRapid antigen diagnostic test (point-of-care antigen detection)

NAATNucleic acid amplification test (includes PCR, HDA, RNAT) — higher sensitivity molecular assays

MALDI-TOFMatrix-assisted laser desorption/ionization–time of flight (instrument identification method)

Solana Strep Complete Assay (HDA) — definition

Policy Revision History

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Revision history not available in the policy inventory; maintain this timeline when dated revision entries are added to the policy record.

Policy Summary

PayerBlue Cross Blue Shield - Tennessee

Policyβ-Hemolytic Streptococcus Testing (Coverage Criteria)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionConfirm benefit coverage and prior authorization requirements before ordering multiplex or excluded streptococcal assays.

SourceLink

On This Page

Includes age adjustment plus tonsillar findings, lymphadenopathy, fever, and absence of cough

Clinical intentReserve testing for patients with high suspicion for GAS and intention to treat with antibiotics

Placeholder — no additional coding highlights

Coding highlightsNone specified in brief/source for this placeholder block

ActionNo additional codes or thresholds to add

ReferenceSee policy code lists and device summaries for applicable CPT/HCPCS and FDA references

Use modified Centor score (tonsillar exudates, tender anterior cervical lymphadenopathy, fever, absence of cough) and age to guide testing; score ≥3 supports testing.
Avoid testing when viral symptoms (cough, rhinorrhea, hoarseness, oral ulcers, conjunctivitis) are present.
Testing generally not indicated for children younger than 3 years (unless specific mitigating circumstances).

Billing Rule

Procedure codes requiring payer confirmation

Some CPT/HCPCS procedure codes referenced in this policy may have payer-specific prior authorization or reimbursement rules. Confirm with the payer before ordering or billing.

Relevant codes include, but may not be limited to: 86060, 86063, 86215, 86317, 86318, 87040, 87070, 87071, 87077, 87081, 87430, 87650, 87651, 87652, 87797, 87798, 87799, 87880.
Procedure codes appearing in policy are for reference only and may not be all-inclusive; verify payer requirements for listed codes.

Denial Risk

Tests likely to be denied

Ordering RADT or other tests in situations explicitly listed as not meeting coverage criteria (e.g., as screening in asymptomatic patients, follow-up to culture, for suspected viral pharyngitis, panel tests) may be denied.

RADT DOES NOT MEET COVERAGE CRITERIA as a follow-up to culture, as screening in asymptomatic patients, or for individuals with suspected viral pharyngitis (except specific pediatric exceptions).
Panel tests that identify multiple streptococcal strains, MALDI-TOF for streptococcus identification, and quantitative NAATs DO NOT MEET COVERAGE CRITERIA.

Note

Indications-based testing

Indications-based testing: perform culture, RADT, NAAT, or serology only when coverage criteria and clinical indications are met (e.g., Centor ≥3, absence of viral features, suspected ARF requiring serology). Do not routinely test low-risk outpatients.

Throat culture meets coverage when modified Centor ≥3, absence of viral features, or following a negative RADT in a symptomatic child/adolescent.
Serological titers (ASO, anti-DNase B) meet coverage for suspected ARF or PSGN and require paired acute/convalescent titers to demonstrate rise.
Do not routinely obtain sputum or blood cultures in outpatients with low suspicion for invasive GAS disease (see ATS/IDSA guidance).

Note

Appropriate test utilization to avoid routine testing in low-risk outpatients

Avoid routine testing in low-risk outpatients; testing should generally be reserved for patients with high suspicion for GAS and when results will influence antibiotic treatment.

Patients with Centor score <3 or with viral features generally do not require strep testing or antibiotics.
Testing should be performed when there is intention to treat with antibiotics and a high pretest probability exists.

Note

None specified: reimbursement and step-therapy

No additional payer-specific reimbursement restrictions or step-therapy requirements are specified in the provided excerpts beyond the coverage criteria and procedure-code verifications noted above.

No step therapy requirements are described in these excerpts.
Reimbursement is governed by the coverage criteria and payer-specific rules. Confirm with the payer as needed.

Documentation Required

Documentation expectations

Document clinical findings and rationale when ordering tests: record modified Centor score (or its components), presence or absence of viral features, patient age, and intention to treat. For pediatric RADT reflex testing, document the negative antigen result and rationale for reflex culture/NAAT.

For throat culture coverage, document modified Centor score ≥3 or absence of viral features.
For pediatric RADT follow-up, document negative RADT result and clinical rationale for reflex culture or NAAT.
When ordering rapid antigen or molecular tests, document signs/symptoms consistent with pharyngitis and test sensitivity considerations.

Documentation Required

Laboratory evidence for ARF

Laboratory evidence for suspected acute rheumatic fever (ARF) must be confirmed by rising/paired ASO or anti-DNase B titers, or by a positive rapid antigen or throat culture when clinically appropriate. A single titer is less convincing than a documented rise between acute and convalescent samples.

Obtain paired acute and convalescent ASO or anti-DNase B titers (≥2 weeks apart) to demonstrate rise.
A positive throat culture or rapid antigen test can support antecedent GAS infection in appropriate clinical context.
Recognize that titers peak weeks after infection; absence of rise may occur with delayed ARF presentations such as chorea.

Documentation Required

Clinical indication and test sensitivity documentation

Document test sensitivity and clinical indication when ordering rapid antigen or molecular tests; in pediatric patients, use a two-step testing algorithm when using RADT (RADT with reflex to culture or sensitive NAAT if negative).

Collect a dual swab in pediatric patients to enable reflex culture/NAAT if RADT is negative.
If a RADT with sensitivity <80% is negative in a child, perform a second specimen tested by culture or a sensitive NAAT to arbitrate false negatives.
Negative direct NAAT results typically do not require secondary arbitration.

Documentation Required

No explicit documentation requirements listed

No explicit additional documentation requirements beyond those above are listed in the provided excerpts; however, retain clinical records that justify testing per coverage criteria and payer requests.

Maintain documentation of signs/symptoms, modified Centor score, test results (including negative RADT when reflex testing performed), and rationale for testing.
Device performance summaries and FDA clearances cited in the policy inform test selection but do not replace required clinical documentation.

Step Therapy

Two-step testing algorithm (pediatrics)

Two-step testing algorithm in pediatrics: perform RADT at point-of-care with reflex to culture or sensitive NAAT if RADT is negative and clinical suspicion remains high. Collect dual swabs initially to enable reflex testing without recollection.

Use RADT as initial test in children; if negative and RADT sensitivity <80%, reflex to culture or sensitive NAAT.
Collect a dual swab at initial visit; discard second swab if RADT is positive to avoid repeat collection.

Note

Reflex/back-up testing workflow

Reflex/back-up testing workflow: for children with negative RADT and persistent clinical suspicion, perform throat culture or a sensitive NAAT as a backup. For adults, secondary testing is not routinely required after negative RADT if clinical context allows.

In pediatric patients, negative RADT should be followed by culture or sensitive NAAT when necessary to rule out false negatives.
Direct and amplified NAATs are more sensitive and negative NAATs generally do not require arbitration by a secondary test.
Document rationale for reflex testing in the medical record.

Step Therapy

Arbitration testing in children after negative antigen

Arbitration testing in children after negative antigen: when a direct antigen test in pediatric patients is negative and the test sensitivity is <80%, perform a second specimen tested by culture or NAAT to arbitrate possible false negatives.

If using a RADT known to have sensitivity <80% and result is negative in a symptomatic child, proceed to culture or sensitive NAAT on a second specimen.
Collect and retain documentation of the negative antigen result and subsequent arbitration testing.

Note

No step therapy requirements described

No step-therapy requirements are described in the provided excerpts; follow clinical guidelines (CDC, IDSA, AAP, ICSI) for diagnostic workflow and management decisions.

No step therapy described in these excerpts.
Follow cited clinical guidelines for testing algorithms and management.

Test nameSolana Strep Complete Assay (Quidel) — FDA-cleared isothermal HDA rapid assay for qualitative detection and differentiation of Group A and Group C/G streptococci from throat swabs

PerformanceReported clinical sensitivity for GAS ~98.8% and specificity ~98.9% (Solana GAS in 510(k) summary)

TurnaroundReported run time ~25 minutes (Solana) vs 60–70 minutes for Lyra per FDA summary

Lyra Direct Strep Assay (real-time PCR) — definition

Test nameLyra Direct Strep Assay — FDA-approved real-time PCR NAAT that qualitatively detects GAS and GGS/GCS in throat swabs

LimitationDoes not distinguish between Group G and Group C streptococci (GGS vs GCS)

Operational noteReported longer run time (60–70 minutes) compared with some HDA methods

RNAT / Point-of-care NAAT — rapid molecular tests

DefinitionRNAT / POC NAAT — rapid nucleic acid amplification tests performed at point-of-care using molecular methods

Diagnostic performanceMeta-analysis (Dubois et al.) RNAT sensitivity ~97.5% and specificity ~95.1% — higher sensitivity than RADT

Clinical implicationHigh-sensitivity RNATs may be used as standalone diagnostics without culture arbitration

Modified Centor score — definition and use

DefinitionModified Centor score — clinical scoring system (age plus Centor components) used to stratify likelihood of GAS pharyngitis

UseGuidelines (ICSI) recommend not testing when modified Centor <3; test when score ≥3

ComponentsAge adjustment plus tonsillar exudates, tender anterior cervical lymphadenopathy, fever, absence of cough

Laboratory-developed test (LDT) — definition

DefinitionLaboratory-developed test (LDT) — a test developed and validated by a laboratory for in-house use; regulated under CLIA as high-complexity and not FDA-cleared

RegulationLDTs are regulated by CMS under CLIA '88; FDA clearance/approval is not required for clinical use

ImplicationLDTs require laboratory validation and CLIA compliance prior to clinical use

Rapid molecular assays / NAATs — definition

DefinitionRapid nucleic acid amplification tests / rapid molecular assays — molecular assays for detection of Group A (and in some devices Group C/G) streptococci using NAAT technologies

ExamplesSolana HDA, Lyra PCR, Simplexa qPCR, Alere i NAAT (referenced studies) — assay-specific performance varies

Performance noteReported sensitivities for some assays often ≥95%; RNAT pooled sensitivity ~97.5%

Rapid antigen detection tests (RADT) — definition and utility

DefinitionRapid antigen detection tests (RADT) — point-of-care antigen tests for Group A Streptococcus commonly used in outpatient settings

PerformanceRADT pooled sensitivity lower than RNATs (RADT sensitivity ~82.3% per meta-analysis); specificity generally high

Pediatric workflowIn children, a negative RADT with sensitivity <80% should be followed by NAAT or throat culture to arbitrate false negatives