β-Hemolytic Streptococcus Testing
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Medical coverage policy for laboratory testing to detect β-hemolytic Streptococcus (Groups A, B, C, G) and related diagnostic methods; governs when cultures, RADT, NAAT, serology, and other tests are covered for Blue Cross Blue Shield - Tennessee members.
No material clinical or coverage changes in this revision.
Coverage Criteria for β-Hemolytic Streptococcus Testing
inv-01: Tests meeting coverage criteria
Covered when ANY of the following are met
See Note 1 for Centor components
inv-02: Tests not meeting coverage criteria
Not covered (does not meet coverage criteria)
inv-03: Appropriate testing criteria
Testing for GAS pharyngitis is appropriate when ALL of the following apply:
ICSI consensus: reserve testing for high suspicion and intention to treat
NAAT/RNAT may be used as standalone given higher sensitivity
inv-04: Not routinely indicated
Testing is NOT routinely indicated when ANY of the following apply:
AAP/CDC guidance
CDC/AAP comments on carriers
inv-05: Testing for Streptococcal Pharyngitis
Covered when ALL of the following are met
ICSI recommends reserving testing for patients with high suspicion and intention to treat
inv-06: Culture testing in respiratory infection (CAP)
Covered when ALL of the following are met
ATS/IDSA and PIDS-IDSA guideline statements
inv-07: Group B Streptococcus (GBS) screening and identification
Covered when ALL of the following are met
ACOG recommendation endorsed by ASM
ASM guideline statements
The policy lists specific test types that do not meet coverage criteria. These include panel tests that screen and identify multiple streptococcal strains (for example, the Solana Strep Complete Assay and Lyra Direct Strep Assay), MALDI-TOF identification of streptococcus, and nucleic acid quantification of streptococcal strains. Additionally, several serologic and enzymatic assays are excluded except when used to evaluate suspected post-streptococcal complications: anti-streptolysin O immunoassay, hyaluronidase activity/anti-hyaluronidase, streptokinase activity/anti-streptokinase, and similar immunoassays are not covered except in cases of suspected acute rheumatic fever (ARF) or post-streptococcal glomerulonephritis (PSGN). The policy also states that simultaneous coding for BOTH amplification and direct probes does not meet coverage criteria.
Clinical guidance and this policy exclude routine testing for certain populations and clinical presentations. Testing for group A streptococcal (GAS) pharyngitis is not routinely indicated for children younger than 3 years, except in limited circumstances (for example, a symptomatic household contact), and patients with clear viral features (eg, cough, rhinorrhea, hoarseness, oral ulcers, conjunctivitis) should generally not be tested. The policy further specifies that RADT does not meet coverage criteria when used as a follow-up to culture, as screening in asymptomatic patients, or in cases of suspected viral pharyngitis.
The policy references the NICE appraisal which concludes that rapid tests for Group A strep are not recommended for routine adoption for people with sore throat because they are unlikely to meaningfully improve antimicrobial prescribing, stewardship, or patient outcomes compared with clinical scoring tools alone.
Within the provided excerpt there are no additional explicit exclusions enumerated beyond those already detailed elsewhere in the policy and referenced guidance.
The policy clarifies several uses of rapid antigen detection tests (RADTs): RADT should not be used as a follow-up to culture results nor as a screening tool in asymptomatic patients, and RADT is not indicated in suspected viral pharyngitis. CDC and AAP guidance note that a positive RADT in children can confirm GAS, but a negative RADT in symptomatic children should be followed by throat culture. Serologic titers (eg, ASO, anti-DNase B) are reserved for evaluation of suspected ARF or PSGN rather than routine diagnosis of acute pharyngitis.
Guideline consensus does not support broad point-of-care testing in patients with a low pretest probability of disease. The ICSI and AAP recommend reserving testing for patients with higher clinical suspicion and an intention to treat; routine use of point-of-care RADT or NAAT in low-suspicion patients (eg, modified Centor <3 or presence of viral features) is not supported and therefore discouraged.
Testing for GAS is not indicated when the modified Centor score is less than 3 or when viral features (rhinorrhea, cough, oral ulcers, hoarseness) are present; the ICSI consensus explicitly advises against testing in these scenarios. Separately, for outpatient community-acquired pneumonia management, ATS/IDSA guidance recommends not routinely obtaining sputum Gram stain/culture or blood cultures in adults managed as outpatients.
In the portion of the document provided there are no standalone 'not medically necessary' statements beyond the coverage and exclusion language already described in policy sections and referenced guideline summaries.
Coding and Regulatory References
| K133833 | Lyra Direct Strep Assay FDA 510(k) number |
| K162274 | Quidel Solana Strep Complete Assay product clearance |
| K183366 | GenePOC Revogene Strep A assay clearance reference (FDA summary K183366 cited) |
| K201269 | Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System (FDA reference) |
| No codes listed |
Provider Actions, Documentation, and Billing Considerations
Prior Authorization / Authorization Status
This policy excerpt does not specify any prior authorization requirements for specific named assays (e.g., Lyra Direct Strep, Solana, GenePOC, Accula™) nor does it list prior authorization rules in the references or FDA sections. Providers should not assume a formal prior authorization process is required for these assays based on this document alone; verify member benefit coverage separately when indicated.
- Named FDA-cleared assays referenced: Lyra Direct Strep, Solana Strep Complete, GenePOC Strep A, Mesa Biotech Accula™ Strep A
- No prior authorization or step therapy rules are listed for these assays in this policy excerpt
Documentation for ARF / PSGN Evaluation
Documentation must support testing ordered for evaluation of suspected acute rheumatic fever (ARF) or post-streptococcal glomerulonephritis (PSGN). Examples of acceptable laboratory evidence include throat culture, rapid antigen diagnostic test (RADT), and rising or serial antistreptococcal antibody titers (e.g., ASO, anti-DNase B). A rise in titer from acute to convalescent samples (at least two weeks apart) is preferred evidence of antecedent GAS infection.
- Obtain and document acute and convalescent ASO and/or anti-DNase B titers when evaluating for ARF/PSGN; note timing (>=2 weeks apart) and rising titer
- Throat culture or positive RADT in context of compatible clinical presentation may serve as antecedent infection evidence
- If ASO titer is undetectable but clinical suspicion remains, consider anti-DNase B or other antistreptococcal antibody testing
Clinical Justification & Test Method Documentation
Clinical justification and method of testing should be clearly documented in the medical record. Include presenting signs/symptoms, modified Centor score or presence/absence of viral features, reason for testing (diagnostic vs. screening), and the specific test modality performed (RADT, NAAT, culture, serology).
- Record modified Centor score when used; testing generally indicated when score >=3
- Document absence of viral features (cough, rhinorrhea, oral ulcers, hoarseness) when ordering GAS testing
- Specify test type in the chart note (e.g., point-of-care RADT, NAAT, laboratory throat culture, serologic assay) to support medical necessity
Appropriate Testing Indications
Testing should be performed only for appropriate indications per guidelines: reserve testing for patients with high clinical suspicion for GAS (modified Centor >=3 or lack of viral features), symptomatic children/adolescents per pediatric guidance, and not for routine screening of asymptomatic individuals or children <3 years (except select circumstances).
- Do not test patients with clear viral symptoms (cough, rhinorrhea, conjunctivitis, hoarseness, oral ulcers)
- Do not routinely test children <3 years unless symptomatic household contact or outbreak scenario
- Use testing to guide antibiotic therapy decisions when there is intention to treat
Denial Risk / Non‑Covered Testing Triggers
Potential denial or non-coverage may occur when testing is not aligned with guideline indications. Common denial triggers include testing when modified Centor <3, testing in suspected viral pharyngitis, use of RADT as screening in asymptomatic patients, or simultaneous coding for both amplification and direct probe methods.
- Denied/not covered scenarios include: testing in suspected viral pharyngitis, RADT as follow-up to culture, RADT for asymptomatic screening, simultaneous billing for amplification and direct probe tests
- Panel assays (e.g., Solana Strep Complete, Lyra Direct Strep) and MALDI-TOF identification are listed as not meeting coverage criteria
- Certain serologic assays (anti-streptolysin O, hyaluronidase, streptokinase, NADase) are not covered except when evaluating suspected ARF or PSGN
Testing Sequence & Reflex Testing Practices
Testing sequence and reflex practices: for pediatric patients, a negative RADT performed with an assay known to have sensitivity <80% should be followed by a more sensitive NAAT or by throat culture. In adults, secondary testing after a negative RADT is not routinely required when using higher-sensitivity NAATs. Collecting a dual swab at initial specimen collection facilitates reflex testing when needed.
- Pediatric negative RADT with low-sensitivity assay: reflex to NAAT or culture
- Direct/amplified NAATs are sufficiently sensitive that negative NAATs typically do not require secondary arbitration
- Consider dual-swab collection at the initial visit to allow immediate reflex testing
Billing Considerations & Additional Provider Actions
Other provider action and billing considerations: the policy does not include step therapy rules or quantity limits in this section. Providers should avoid ordering tests explicitly listed as not covered (panel assays, MALDI-TOF, unsupported serologic assays) and should not bill for simultaneous amplification and direct probe assays for the same encounter.
- No step therapy or quantity-limit rules specified in this policy excerpt
- Avoid simultaneous coding of amplification and direct probe methods (listed as not meeting coverage)
- Refer to cited guidelines (CDC, AAP, IDSA, AHA, FDA notices, UpToDate) for clinical decision-making and documentation expectations
Background and Context
Group A Streptococcus (GAS) is an important cause of bacterial pharyngitis and can lead to complications including scarlet fever, acute rheumatic fever (ARF), and post-streptococcal glomerulonephritis (PSGN). GAS accounts for approximately 20–30% of sore throats in children and 5–15% in adults. Clinical scoring systems such as the modified Centor (McIsaac) criteria are used to estimate the probability of GAS infection and guide testing decisions; a score of ≥3 supports diagnostic testing. Serologic testing (ASO, anti-DNase B) is useful to document antecedent infection when evaluating suspected ARF or PSGN, with rising titers over weeks providing the strongest evidence.
Definitions
Revision History
Policy became effective and adopted the Avalon policy recommendation.
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