CurrentBlue Cross Blue Shield - TennesseePolicy N/A

β-Hemolytic Streptococcus Testing

Coverage rules for laboratory testing to detect β-hemolytic Streptococcus infections (throat, blood, skin, serologies, RADT, and nucleic acid tests) for BlueCross BlueShield of Tennessee members.

Policy Summary

PayerBlue Cross Blue Shield - Tennessee

Policyβ-Hemolytic Streptococcus Testing

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionOrder culture or diagnostic testing only when documented clinical criteria are met (e.g., modified Centor score ≥3, absence of viral features, failure to improve, or suspected prosthetic joint infection).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Multipleprocedure code references included

≥10distinct coverage/denial statements

4+named FDA-approved tests referenced

7+clinical guideline citations

Coverage Criteria — Indications and Limitations

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Medically necessary / Covered indications

Covered when ANY of the following are met:

Throat culture for respiratory illness: Bacterial culture testing from a throat swab meets coverage when ONE of the following is present: (a) modified Centor criteria score of 3 or greater; (b) suspected bacterial pharyngitis in the absence of viral features (e.g., cough, oral ulcers, rhinorrhea); OR (c) following a negative rapid antigen diagnostic test (RADT) in a symptomatic child or adolescent.modified Centor >=3

See policy Note 1 for Centor components

Blood culture testing meets coverage when ONE of the following is present: failure to demonstrate clinical improvement; progressive symptoms or clinical deterioration after initiation of antibiotic therapy; OR suspected prosthetic joint infection.clinical deterioration or lack of improvement

Skin/soft tissue infection culture: Bacterial culture testing from a skin swab or from pus meets coverage for skin and/or soft tissue infections.

Post-streptococcal/ARF serology: For suspected acute rheumatic fever (ARF) or post-streptococcal glomerulonephritis (PSGN), serological titer testing and specific assays (anti-streptolysin O immunoassay, hyaluronidase activity or anti-hyaluronidase immunoassay, streptokinase activity or anti-streptokinase immunoassay) meet coverage criteria.

Not medically necessary / Not covered

Not covered in the following situations:

Viral pharyngitis: In cases of suspected viral pharyngitis, bacterial culture testing from a throat swab DOES NOT MEET COVERAGE CRITERIA.

RADT limitations: Except for asymptomatic children under age three years with a mitigating circumstance (including a symptomatic family member), RADT for streptococcal infection DOES NOT MEET COVERAGE when used as follow-up to culture or NAAT, as a screening method in an asymptomatic patient, or for suspected viral pharyngitis.age <3 exception only

Serologic and panel tests: For situations not described as covered, serological titer testing, anti-streptolysin O immunoassay, hyaluronidase or streptokinase assays, panel tests that screen multiple streptococcal strains (e.g., Solana Strep Complete Assay, Lyra Direct Strep Assay), MALDI-TOF identification, nucleic acid quantification of streptococcus, and nicotinamide-adenine dinucleotidase assays DO NOT MEET COVERAGE CRITERIA.

See policy list of non-covered tests

Simultaneous duplicate NAAT methods: Simultaneous ordering of both direct probe and amplification probe for the same organism in a single encounter DOES NOT MEET COVERAGE CRITERIA.

Panel-based assays that simultaneously screen for multiple streptococcal strains (for example, assays that detect Group A, B, C, and G or alpha/gamma-hemolytic species) are listed as not meeting coverage. The policy specifically names examples such as the Solana Strep Complete Assay and the Lyra Direct Strep Assay as non-covered panel tests that use immunoassay or nucleic acid–based methods. MALDI-TOF identification of streptococcal species is also listed as not meeting coverage, as is the quantification of streptococcal nucleic acid (NAAT/PCR) and certain enzymatic immunoassays (e.g., nicotinamide-adenine dinucleotide assays).

Although several named assays have FDA clearance or approval (for example, the Lyra Direct Strep Assay and the Solana Strep Complete Assay are described in the policy source), the coverage stance remains that multispecies screening panels and identification by MALDI-TOF or nucleic acid quantification are excluded due to insufficient published evidence of clinical benefit for the listed indications.

The document contains reference material and citations supporting diagnostic evaluation of streptococcal infections (peer-reviewed studies, FDA 510(k) summaries, and guideline sources). These reference-only sections do not themselves introduce additional explicit coverage exclusions beyond those enumerated elsewhere in the policy.

Rapid antigen detection tests (RADTs) for streptococcal infection are limited by the policy. RADT use is not covered as a follow-up test after a culture or NAAT, as a screening method in asymptomatic patients, or for individuals with suspected viral pharyngitis, except for an explicit narrow exception for asymptomatic children under age 3 years with a mitigating circumstance (such as a symptomatic household member). Ordering a bacterial throat culture for suspected viral pharyngitis is specifically stated to not meet coverage.

In operational terms, providers should avoid ordering RADT for screening of asymptomatic patients or to evaluate likely viral sore throat, and should not use RADT as a redundant follow-up to more definitive culture or molecular testing. Clinical documentation supporting indication (symptoms, Centor score, or other viral features) should accompany orders when testing is pursued for covered indications.

Tests and Indications That Are Covered

Throat swab culture criteria for suspected bacterial pharyngitis when Centor >=3, absence of viral features, or negative RADT in symptomatic child/adolescent

Covered throat swab culture when ANY of the following are met:

Modified Centor score >=3: Obtain bacterial culture from a throat swab when the patient has a modified Centor criteria score of 3 or greater.modified Centor >=3

Modified Centor components (tonsillar exudates, tender anterior cervical lymphadenopathy, fever, absence of cough) should be documented.

Absence of viral features: Obtain bacterial culture when bacterial pharyngitis is suspected in the absence of viral features such as cough, oral ulcers, or rhinorrhea.absence of viral features

Document presence/absence of viral features in clinical record.

Negative RADT in symptomatic child/adolescent: Obtain bacterial culture following a negative rapid antigen diagnostic test (RADT) in a symptomatic child or adolescent.symptomatic child/adolescent with negative RADT

Blood cultures — when lack of improvement, progressive symptoms after antibiotics, or suspected prosthetic joint infection

Blood culture testing meets coverage when ANY of the following clinical scenarios are present:

Lack of clinical improvement: Obtain blood cultures for individuals who fail to demonstrate clinical improvement.failure to improve

Document lack of improvement in clinical record.

Progressive symptoms after antibiotics: Obtain blood cultures for individuals with progressive symptoms or clinical deterioration after initiation of antibiotic therapy.progressive symptoms/clinical deterioration after antibiotics

Suspected prosthetic joint infection: Obtain blood cultures in cases of suspected prosthetic joint infection.suspected prosthetic joint infection

Skin or pus culture for skin and soft tissue infections

Skin or pus culture meets coverage when performed for clinical diagnosis of skin/soft tissue infection:

Skin/soft tissue infection culture: Bacterial culture testing from a skin swab or from pus meets coverage when used to evaluate suspected skin and/or soft tissue infections.

Follow standard specimen collection procedures; reference IDSA skin and soft tissue infection guidance as applicable.

Serological testing (ASO, anti-hyaluronidase, streptokinase titers) for suspected ARF or PSGN

Serological testing meets coverage when performed for suspected post-streptococcal immune complications:

Serological titer testing for ARF/PSGN: Serological titer testing meets coverage for individuals with suspected acute rheumatic fever (ARF) or post-streptococcal glomerulonephritis (PSGN).

Anti-streptolysin O immunoassay: Anti-streptolysin O (ASO) immunoassay meets coverage when used in the evaluation of suspected ARF or PSGN.

Hyaluronidase activity/assay: Hyaluronidase activity testing or anti-hyaluronidase immunoassay meets coverage for suspected ARF or PSGN.

Streptokinase activity/assay: Streptokinase activity testing or anti-streptokinase immunoassay meets coverage for suspected ARF or PSGN.

Diagnosis of Group A, B, C, and G streptococcal infections — supporting evidence and guidance

Diagnostic testing for Group A, B, C, and G streptococcal infections is supported when aligned with clinical presentation and guideline-based methods:

Group A strep diagnosis: Diagnosis of Group A streptococcal infection may be established using RADT, culture, or nucleic acid amplification tests when applied per clinical guidelines and policy criteria (see Centor-based indications and RADT limitations).

Refer to cited studies and guideline sources for test performance (e.g., Solana, Alere i, comparative evaluations).

Groups C/G and B strep evaluation: Evaluation for Group B, C, and G streptococcal infections using appropriate laboratory methods is supported when clinically indicated for respiratory or soft tissue infections; testing approach should follow diagnostic guidance and cited literature.

See referenced comparative and guideline literature for assay selection and interpretation.

Tests and Uses That Are Not Covered

The policy lists multiple categories of tests and situations that do not meet coverage: panel assays that detect multiple streptococcal strains (e.g., Solana Strep Complete Assay, Lyra Direct Strep Assay), MALDI-TOF identification of streptococcus, and quantification of streptococcal nucleic acid by NAAT/PCR. Additionally, certain enzymatic immunoassays such as nicotinamide-adenine dinucleotide activity assays and broad serologic testing outside the defined indications are listed as not covered.

The policy also identifies procedural ordering denials that can result from duplicative testing practices: simultaneous ordering of both direct probe and amplification probe NAAT methods for the same organism in a single encounter does not meet coverage. These items are presented as not covered due to lack of published scientific literature demonstrating clinical benefit for the indicated purposes.

Reference-only portions of the policy include literature citations, FDA 510(k) summaries, and diagnostic performance studies that support the broader diagnostic context. These sections do not themselves enumerate additional non-covered tests or exclusions beyond the policy statements.

CPT / HCPCS / Procedure Codes

Serology and immunoassay CPT codesCPT

86060	Antistreptolysin O; titer
86063	Antistreptolysin O; screen
86215	Deoxyribonuclease, antibody
86317	Immunoassay for infectious agent antibody, quantitative, NOS
86318	Immunoassay for infectious agent antibody(ies), qualitative or semiquantitative

Culture, antigen, and nucleic acid CPT codesCPT

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
87071	Culture, bacterial; quantitative, aerobic with isolation and presumptive identification
87077	Culture, bacterial; aerobic isolate, additional methods required for definitive identification
87081	Culture, presumptive, pathogenic organisms, screening only
87430	Infectious agent antigen detection by immunoassay; Streptococcus, group A
87650	Infectious agent detection by nucleic acid; Streptococcus, group A, direct probe technique
87651	Infectious agent detection by nucleic acid; Streptococcus, group A, amplified probe technique
87652	Infectious agent detection by nucleic acid; Streptococcus, group A, quantification
87797	Infectious agent detection by nucleic acid, NOS; direct probe technique, each organism

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inv-09: Modified Centor score — clinical threshold note (>= 3)

Modified Centor score threshold>= 3

Use for throat swab culture coverageThroat culture meets coverage when modified Centor score is 3 or greater

Reference noteSee Note 1 for Centor components (tonsillar exudates, tender anterior cervical lymphadenopathy, fever, absence of cough)

Provider Requirements, Documentation, and Authorization

Denial Risk

Triggers for Denial

Denial triggers: Ordering bacterial throat culture or RADT when viral pharyngitis is suspected (presence of viral features such as cough, oral ulcers, rhinorrhea) is not covered. Simultaneous ordering of both direct probe and amplification probe for the same organism in a single encounter is not covered. Use of panel tests that screen/identify multiple streptococcal strains, MALDI-TOF identification, nucleic acid quantification (including PCR) of streptococcal strains, and other listed assays (see policy) do not meet coverage criteria and risk denial.

Bacterial throat culture for suspected viral pharyngitis — denial condition
RADT for suspected viral pharyngitis — denial condition
Simultaneous direct probe + amplification probe for same organism in one encounter — denial condition
Panel tests identifying multiple streptococcal strains (e.g., Solana Strep Complete Assay, Lyra Direct Strep Assay) — not covered
MALDI-TOF identification of streptococcus — not covered
Quantification of streptococcal strains using nucleic acid amplification (including PCR) — not covered
Nicotinamide-adenine dinucleotide activity / related immunoassays — not covered

Note

No Authorization Criteria Specified

No explicit prior authorization or separate authorization criteria are specified in this policy section. Providers should follow standard benefit verification processes and the member's plan coverage rules at the time of service. Absence of authorization criteria here does not imply coverage; tests must still meet the policy's clinical indications and documentation requirements to be payable.

Documentation Required

Clinical Documentation Expectations

Document the clinical rationale for testing. For pharyngitis: record the modified Centor score and note absence or presence of viral features (cough, rhinorrhea, oral ulcers). For blood cultures: document clinical signs that justify blood culture collection (e.g., failure to improve, clinical deterioration, suspected prosthetic joint infection). Clear documentation supports medical necessity and reduces denial risk.

Record modified Centor score when ordering throat testing
Note presence/absence of viral features (cough, rhinorrhea, oral ulcers)
Document clinical rationale for blood cultures (failure to improve, deterioration, suspected prosthetic joint infection)

How Tests Should Be Ordered

Note

Order based on documented clinical criteria

Order testing based on documented clinical criteria (for example, modified Centor score, absence of viral features) or specific clinical scenarios such as failure to improve, progressive symptoms after antibiotics, suspected prosthetic joint infection, or suspected ARF/PSGN.

Throat culture: document modified Centor score >= 3 OR absence of viral features OR negative RADT in a symptomatic child/adolescent.
Blood cultures: document failure to improve, progressive symptoms after antibiotics, or suspected prosthetic joint infection.

Note

No provider-type ordering requirements specified

No ordering provider requirements (such as specific provider type) are specified in the policy's reference sections.

Key Definitions and Clinical Criteria

inv-19: Modified Centor criteria — items and scoring (tonsillar exudates, tender anterior cervical lymphadenopathy, fever, absence of cough)

Tonsillar exudates1 point

Tender anterior cervical lymphadenopathy1 point

Fever1 point

Absence of cough1 point

inv-20: Guideline references — IDSA and ATS guideline citations and related notes

IDSA/ATS CAP guideline (2019)Metlay JP et al., Diagnosis and Treatment of Adults with Community-acquired Pneumonia. Am J Respir Crit Care Med. 2019;200(7):e45-e67.

IDSA Microbiology Laboratory Guide (2018)Miller JM et al., A Guide to Utilization of the Microbiology Laboratory for Diagnosis of Infectious Diseases: 2018 Update. Clin Infect Dis. 2018;67(6):e1-e94.

IDSA SSTI guideline (2014)Stevens DL et al., Practice Guidelines for the Diagnosis and Management of Skin and Soft Tissue Infections. Clin Infect Dis. 2014;59(2):e10-e52.

Clinical Background and Rationale

Streptococcus species cause a spectrum of disease from pharyngitis (commonly Group A Streptococcus, S. pyogenes) to skin and soft tissue infections, invasive disease, and post-infectious immune complications such as acute rheumatic fever (ARF) and post-streptococcal glomerulonephritis (PSGN). Diagnostic methods discussed in the policy include conventional culture, rapid antigen detection tests (RADT), and nucleic acid–based assays (NAAT/PCR); the document also references molecular and platform-specific FDA-cleared assays (for example, Lyra, Solana, GenePOC, Accula) and laboratory-developed tests regulated under CLIA.

The policy frames coverage around clinical context: throat culture is covered for suspected bacterial pharyngitis when clinical criteria such as a modified Centor score >= 3, absence of viral features, or a negative RADT in a symptomatic child/adolescent are present. Blood cultures are covered for patients who fail to improve, have progressive symptoms after antibiotics, or in suspected prosthetic joint infection. Serologic testing (titers and specific immunoassays) is covered when ordered for suspected ARF or PSGN; conversely, broad serologic testing and certain advanced identification or quantification methods are listed as not covered.

Policy Revision History

2022-?literature_update

Added citation for McCarty et al. 2022 evaluating analytical performance of GenMark Dx ePlex blood culture identification gram-positive panel.

2019-?guideline_reference

Included IDSA 2019 guidance on diagnosis and prevention of periprosthetic joint infections as a supporting reference for blood culture indications.

2016-?device_clearance_reference

Referenced FDA 510(k) premarket notification K162274 for Solana Strep Complete Assay to support named assay examples.

2019-?research_citationLatest

Added Kim et al. 2019 performance evaluation of three rapid antigen tests for group A Streptococci to support RADT performance statements.

Policy Summary

PayerBlue Cross Blue Shield - Tennessee

Policyβ-Hemolytic Streptococcus Testing

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

OpenPayer

β-Hemolytic Streptococcus Testing

Coverage Criteria — Indications and Limitations

Tests and Indications That Are Covered

Tests and Uses That Are Not Covered

CPT / HCPCS / Procedure Codes

Provider Requirements, Documentation, and Authorization

How Tests Should Be Ordered

Key Definitions and Clinical Criteria

Frequency and Repeat Testing

Clinical Background and Rationale

Policy Revision History