Diagnostic Testing of Common Sexually Transmitted Infections
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Covers medical necessity and coverage criteria for laboratory testing of common STIs (chlamydia, gonorrhea, syphilis, Trichomonas vaginalis, Mycoplasma genitalium, HSV, and HPV) and related PrEP and transplant contexts for BCBS Louisiana members.
Added 'qualitative' to multiple coverage criteria (clarified NAAT language for several conditions).
Moved and reorganized Trichomonas coverage: restored T. vaginalis coverage here and moved some content between this policy and M2057; added Note defining high-risk for trichomoniasis.
Expanded CC10: Qualitative NAAT for T. vaginalis now MEETS COVERAGE in symptomatic patients, follow-up ≥3 months after treatment, annual screening for high-risk asymptomatic patients, annual screening if HIV-positive, and sexual assault follow-up.
Added CPT code 87800 and removed multiple CPT/HCPCS codes (see revision history).
Added new CC23: Nucleic acid testing to determine antimicrobial susceptibility in N. gonorrhoeae or macrolide resistance in M. genitalium DOES NOT MEET COVERAGE.
Allowed multitarget PCR panels to include C. trachomatis, N. gonorrhoeae, T. vaginalis, and M. genitalium when criteria are met.
Indications, Limitations, and Coverage Logic
Provider Action Callout
• Testing modality and documentation: Providers must document the specific assay and specimen type used when ordering STI testing. Authorization and coverage determinations may be affected if the medical record does not state the testing method (e.g., NAAT, PCR, culture, EIA) and the specimen source (eg, first-catch urine, endocervical swab, vaginal swab, pharyngeal swab, rectal swab, lesion exudate, serum, CSF). Laboratory reports should include the FDA clearance/510(k) or PMN identifier when available. • Applicable procedure codes (billing requirement): When submitting claims, include the applicable CPT/HCPCS codes that correspond to the performed assay. Use the code that matches the specific assay performed (eg, organism-specific NAAT CPT codes, multiplex STI panel codes, culture/susceptibility codes). Omitted or incorrect coding may lead to claim denial or request for additional clinical documentation. • Specimen and assay match: The specimen type must be appropriate for the assay per manufacturer instructions and guideline recommendations (eg, NAATs validated for urine vs extragenital swabs; syphilis serology requires serum). Claims for assays performed on non-validated specimen types may be denied. • NAAT requirement for chlamydia and gonorrhea screening: For routine screening and diagnosis of C. trachomatis and N. gonorrhoeae, NAAT (FDA-cleared/validated) is the required modality unless otherwise specified (eg, culture when antimicrobial susceptibility is needed). Document rationale if an alternate method is used. • Syphilis testing sequencing and confirmatory testing: Syphilis coverage requires serologic testing using both treponemal and nontreponemal tests as indicated. Use the recommended sequencing (standard or reverse algorithm) and perform reflex quantitative NTT when appropriate. A single serologic test (only treponemal OR only nontreponemal) is insufficient for diagnosis and may be non-covered without follow-up testing and documentation. If primary screen is positive, perform confirmatory testing or reflex testing per guidelines (eg, reflex quantitative RPR/VDRL and/or TPPA/TPHA) and document results and clinical interpretation. • Syphilis PCR/NAAT: PCR/NAAT for T. pallidum is not covered for routine diagnosis (not FDA-approved commercially); if used, document clinical justification and note any conflict with coverage guidance. Darkfield microcopy or validated lesion NAAT performed in specialized settings should be documented with laboratory validation data. • Conflict with government policy: If an ordering clinician follows a governmental or public-health directive (eg, CDC/health department outbreak response, mandated public health testing), document the directive and relevant guidance in the chart to support coverage; such directives may supersede routine coverage rules. • Clinical documentation to support coverage: For all covered indications, include clinical signs/symptoms, risk factors, timing (eg, screening frequency for PrEP, MSM, HIV-positive individuals), and treatment history when relevant (eg, treatment failure, test-of-cure). For tests of cure, document prior positive test and treatment date. • Assay and specimen documentation: Laboratory reports accompanying claims should state assay name, manufacturer, FDA 510(k) or PMN when available, specimen source, collection date/time, and whether the assay is qualitative or quantitative. For multiplex or panel assays, include which targets were tested and reported. • References and device authorization: When relevant, include reference to FDA 510(k) clearance or PMN numbers for commercial assays in the medical record or laboratory report. Coverage decisions reference FDA-cleared assays (eg, Cepheid Xpert CT/NG, Abbott Alinity m STI, BD Onclarity) and guideline-endorsed methods. • Gonorrhea treatment failure and susceptibility testing: For individuals not responding to recommended therapy, culture with antimicrobial susceptibility testing for N. gonorrhoeae meets coverage criteria and should be ordered; document prior treatment regimen, clinical course, and reason for susceptibility testing. NAAT-based resistance testing does not meet coverage criteria and is not covered. • Step therapy: There are no step therapy requirements for STI diagnostic testing described in this policy. If any formulary or treatment step is relevant to antimicrobial management, document clinical justification for deviation from standard therapy. • Consider near-patient NAATs prior to empiric treatment: When available and clinically appropriate, consider use of near-patient (POC) NAAT to guide therapy to reduce unnecessary empiric treatment; document test availability, result, and how it informed management. • Testing method sequencing and reflex rules: Follow the sequencing and reflex rules described in policy and CDC guidance (eg, reflex quantitative NTT when TT positive; reflex TT when NTT primary screen positive; perform NAAT on appropriate anatomical site when extragenital exposure suspected). Document reflex testing performed and clinical interpretation.
- Document assay name, manufacturer, and FDA 510(k)/PMN when available in lab report and medical record.
- Include appropriate CPT/HCPCS codes that match the specific assay performed on the claim.
- Ensure specimen type is validated for the ordered assay; do not submit tests performed on non-validated specimens without justification.
- Use NAAT (FDA-cleared/validated) for chlamydia and gonorrhea screening and diagnosis unless culture for susceptibility is clinically indicated.
- For syphilis, do not rely on a single serologic test; perform and document treponemal and nontreponemal testing per algorithm and reflex quantitative NTT or confirmatory TT as required.
- If testing conflicts with governmental/public-health directives, document the directive and rationale.
- For possible gonorrhea treatment failure, order culture for susceptibility and document prior treatment; NAAT-based resistance testing is not covered.
- Consider near-patient NAATs where available before empiric therapy to improve antimicrobial stewardship.
Procedure Codes and Billing Guidance
| No codes listed |
| No codes listed |
| No codes listed |
| not specified | Document lists specific test types (NAAT, RPR, VDRL, TPHA, TPPA, EIA/CLIA) but does not provide billing codes in these chunks. |
| 86592 | Syphilis test, non-treponemal antibody; qualitative (eg, VDRL, RPR, ART). |
| 86593 | Syphilis test, non-treponemal antibody; quantitative. |
| 86631 | Antibody; Chlamydia. |
| 86632 | Antibody; Chlamydia, IGM. |
| 86694 | Antibody; herpes simplex, non-specific type test. |
| 86695 | Antibody; herpes simplex, type 1. |
| 86696 | Antibody; herpes simplex, type 2. |
| 86704 | Hepatitis B core antibody (HBcAb); total. |
| 86706 | Hepatitis B surface antibody (HBsAb). |
| 86780 | Antibody; Treponema pallidum. |
| 0064U | Antibody, Treponema pallidum, total and rapid plasma reagin (RPR), immunoassay, qualitative (BioPlex 2200 Syphilis Total & RPR Assay). |
| 0065U | Syphilis test, non-treponemal antibody, immunoassay, qualitative (BioPlex 2200 RPR Assay). |
| 0096U | Human papillomavirus (HPV), high-risk types, male urine (HPV High-Risk, Male Urine). |
| 0210U | Syphilis test, non-treponemal antibody, immunoassay, quantitative (BioPlex 2200 RPR Assay - Quantitative). |
| 0402U | Infectious agent (STI), Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, Mycoplasma genitalium, multiplex amplified probe technique (Abbott Alinity m STI Assay). |
| 0455U | Infectious agents (CT, NG, TV), multiplex amplified probe technique for multiple specimen types (Abbott Alinity m STI Assay). |
| 0463U | Oncology (cervix), mRNA gene expression profiling of 14 biomarkers (E6/E7) (Proofer '7 HPV mRNA E6 and E7 Biomarker Test). |
| 0484U | Mycoplasma genitalium macrolide sensitivity (23S rRNA point mutation), oral/rectal/vaginal swab. |
| 0483U | 0483U. |
| G0499 | Hepatitis B screening in non-pregnant, high risk individual including HBsAg with confirmatory testing and antibodies. |
| 87800 | Added to policy |
Documentation, Prior Authorization, and Laboratory Responsibilities
Prior authorization not specified — coverage per clinical criteria
No specific prior authorization requirements are listed in these sections; coverage is determined by meeting the clinical criteria in the policy.
- Coverage is based on meeting the indicated clinical or risk-based criteria rather than a listed prior authorization rule.
No prior authorization statements in this extract
This partial document contains no payer prior authorization statements; providers should follow benefit-specific prior authorization processes if separately required by the payer.
- Policy text in this extract does not state prior authorization requirements.
Document chosen testing modality (NAAT vs serology) to support coverage
Documentation of testing modality (for example, use of NAAT for chlamydia/gonorrhea or a two-test serologic algorithm for syphilis) may affect coverage decisions and should be included when submitting claims.
- USPSTF and CDC recommendations emphasize NAATs for chlamydia and gonorrhea; document chosen assay and indication.
- Syphilis diagnosis requires treponemal plus nontreponemal serology or appropriate direct detection per algorithm; document which approach was used.
Maintain gonorrhea culture capability for susceptibility testing
Laboratories should maintain or partner for culture capacity for N. gonorrhoeae because culture is required to determine antimicrobial susceptibility when treatment failure or resistance is suspected.
- CDC recommends state and local public health labs maintain or develop gonorrhea culture capacity or form partnerships with experienced labs.
- Culture provides antimicrobial susceptibility information necessary for optimizing treatment and surveillance.
Perform reflex confirmatory testing on same specimen after positive screen
When a screening test is positive, perform the policy-specified reflex confirmatory testing on the same specimen (e.g., reflex quantitative NTT after a positive treponemal test, or reflex TT after a positive NTT).
- If TT used alone and positive, perform reflex quantitative NTT on same serum (quantitative NTT reaching at least 1:8–1:16 dilution).
- If NTT used alone and positive, perform reflex TT on same serum; repeat NTT quantitatively if not done initially.
Use listed CPT/HCPCS/U-codes when billing for covered STI tests
Bill using the exact procedure codes listed in the policy's coding section for covered or referenced STI testing; providers must use the applicable CPT/HCPCS/U-codes shown.
No prior authorization specified in reference section
The reference section of this extract does not specify prior authorization requirements.
- Provider should refer to benefit-specific payer rules for any authorization needs; the reference list itself does not impose prior auth.
Added CPT 87800 — follow standard prior authorization rules
CPT code 87800 was added to the policy's code set; prior authorization requirements for this code follow standard payer rules for laboratory testing codes.
- 87800 is listed in the policy's applicable CPT/HCPCS procedure codes.
- Addition noted in revision history; follow usual payer authorization processes if applicable.
Culture for susceptibility covered after gonorrhea treatment failure
If initial gonorrhea treatment fails, culture for antimicrobial susceptibility meets coverage criteria and should be obtained to guide further therapy.
- Policy: culture testing for N. gonorrhoeae to determine antimicrobial susceptibility MEETS COVERAGE CRITERIA when an individual does not respond to initial treatment.
- CDC guidance supports culture for susceptibility and recommends maintaining culture capacity.
No step therapy requirements specified in this extract
There are no step therapy requirements specified in this partial extract of the policy.
- The policy does not list step therapy sequencing requirements in these sections.
Consider near-patient NAATs before empiric treatment to guide therapy
Consider using near-patient (rapid) NAATs for chlamydia and gonorrhea prior to empiric treatment when available, since rapid tests can reduce overtreatment and undertreatment.
- Near-patient NAATs have high sensitivity (>98%) and specificity and can improve clinical management in settings like the ED by reducing inappropriate treatment.
- Antigen-based POCTs lack sensitivity and are not recommended as stand-alone screening tests.
PrEP monitoring: HIV testing every 3 months and STI screening per CDC
For PrEP monitoring, repeat HIV antigen/antibody and HIV-1 RNA testing at least every 3 months and screen for STIs including syphilis, gonorrhea, and chlamydia per CDC guidance before initiating and during PrEP.
- CDC recommends repeating HIV antigen/antibody and HIV-1 RNA tests at least every 3 months while on PrEP.
- Screen for chlamydia, gonorrhea, and syphilis prior to initiating PrEP and at recommended intervals (e.g., NAAT every 3 months for MSM).
Sequence testing: culture for susceptibility, NAAT preferred for initial diagnosis
When antimicrobial susceptibility testing is needed, culture is required; NAAT remains the preferred initial diagnostic method for chlamydia and gonorrhea when susceptibility testing is not required.
- Policy: culture required for susceptibility testing for certain pathogens (eg, gonorrhea).
- NAAT is preferred for diagnosis due to superior sensitivity for CT/NG in routine settings.
Document patient risk status and symptoms to support covered testing
Document clinical risk status and symptomatic presentation (e.g., high-risk group membership, HIV status, symptoms) to support coverage of indicated STI testing.
- Syphilis antibody testing coverage depends on high-risk status, symptoms, or specific scenarios (e.g., transplant, TOC); document the applicable reason.
- USPSTF/CDC screening criteria (age, risk behaviors) should be documented when ordering NAAT screening for chlamydia/gonorrhea.
Document assay name and specimen source to match intended use
Record the specific assay used and specimen source (for example, urine, cervical, pharyngeal, rectal, lesion swab), because assay performance and intended use vary by specimen and may affect coverage.
- FDA-cleared NAATs have specified specimen types (eg, Xpert CT/NG for urine, vaginal, endocervical, pharyngeal, rectal); document specimen type to match intended use.
- Multiplex assays (eg, Alinity m) list acceptable specimen sources; mismatch or unvalidated specimen use may risk denial.
Syphilis diagnosis requires two serologic tests (NTT + TT); document both
For syphilis, a presumptive diagnosis requires two serologic tests (a nontreponemal test such as RPR/VDRL and a treponemal test such as TP-PA, EIA/CLIA); document use of both tests when applicable.
- CDC: a presumptive diagnosis of syphilis requires use of both a nontreponemal and a treponemal test.
- Policy coverage for syphilis antibody testing references use of standard or reverse algorithms including initial and confirmatory tests.
When TT positive alone, reflex quantitative NTT on same serum and follow discrepant guidance
If a treponemal test is positive when used alone, perform a reflex quantitative nontreponemal test on the same serum; follow the policy reflex instructions for discrepant results and repeat testing as indicated.
- Reflex quantitative NTT should reach at least 1:8 to 1:16 dilution when performed after a positive TT.
- If TT positive and NTT negative with no suspicion of early syphilis, repeat both tests after 1 month per guidance.
Document TT and NTT results and quantitative titers and suspected stage
Document results of both treponemal and non-treponemal tests, including quantitative titers, and document suspected stage of infection when interpreting discordant syphilis serology.
- Record quantitative NTT titers (eg, ≥1:8–1:16 when reflex performed) to support treatment monitoring and interpretation.
- Document suspected stage (eg, early syphilis) when results are discordant to guide repeat testing and management.
LDT validation and CLIA compliance must be documented for in-house tests
Laboratory-developed tests (LDTs) must be validated and are regulated under CLIA '88 as high-complexity tests; document validation and CLIA compliance when using LDTs.
- LDTs are not FDA-approved and must be validated and performed in-house under CLIA regulation.
- Documentation of validation/CLIA compliance is implicit when LDTs are used for clinical testing.
Follow FDA clearance and manufacturer instructions for assay-specific specimen requirements
Follow manufacturer package inserts and FDA 510(k)/PMN documentation for assay-specific specimen and performance requirements when available.
- Policy cites FDA 510(k)/PMN documents and specific assay package inserts (eg, Xpert CT/NG, Alinity m) as references for intended use.
- Use the assay's indicated specimen types and instructions to support coverage and avoid unvalidated uses.
Perform T. vaginalis follow-up NAAT at least 3 months post-diagnosis
Retest for Trichomonas vaginalis using qualitative NAAT at a minimum of three months after the initial diagnosis when indicated by coverage criteria.
- Revision history and policy state follow-up qualitative NAAT for T. vaginalis should be performed a minimum of three months after initial diagnosis.
- Policy CC10 lists follow-up testing ≥3 months as a covered indication.
Use assays validated for the intended specimen types and indications
Use assays that are validated for the specific specimen types and intended uses (eg, use FDA-cleared NAATs for approved specimen sites); unvalidated specimen/assay combinations may lead to denial.
- Cepheid Xpert CT/NG and Abbott Alinity m list specific validated specimen types (urine, vaginal, endocervical, pharyngeal, rectal); follow those indications.
- Deviation from intended specimen types or use of unvalidated assays risks claim denial.
Use NAAT for chlamydia and gonorrhea screening (NAAT required where guideline‑recommended)
NAAT is the required method for chlamydia and gonorrhea screening per guideline recommendations; use of non‑NAAT methods where NAAT is indicated may risk denial.
- USPSTF and CDC recommend NAATs for chlamydia and gonorrhea screening due to superior sensitivity and specificity.
- Antigen-based POCTs with low sensitivity are not adequate as stand-alone screening tests.
Do not rely on a single serologic syphilis test—use two-test algorithm
Using only a single serologic test for syphilis (only NTT or only TT) is insufficient for diagnosis and may lead to false-negative or false-positive conclusions and potential denial of claims if not following the two-test algorithm.
- CDC: a presumptive syphilis diagnosis requires both a nontreponemal and a treponemal test; use of only one test is insufficient.
- Policy coverage for syphilis antibody testing requires standard or reverse algorithm with initial and confirmatory tests.
Failure to perform required syphilis reflex confirmatory testing risks denial
Failure to perform the appropriate reflex confirmatory syphilis testing (eg, not performing quantitative NTT after a positive TT) may lead to inappropriate management and potential claim denial.
- Policy instructs reflex quantitative NTT on the same serum when TT is positive alone and reflex TT when NTT is positive alone.
- Quantitative NTT dilution thresholds (eg, ≥1:8–1:16) are specified for reflex testing.
Government policies (LCD/NCD/State Medicaid) take precedence over this policy
If this policy conflicts with an applicable government policy (eg, Medicare LCDs/NCDs or state Medicaid rules), the government policy takes precedence and claims inconsistent with government coverage may be denied.
- The policy disclaimer states that government policy will be used to make determinations where conflicts exist (LCDs, NCDs, state Medicaid).
No explicit authorization/denial triggers; use FDA-cleared assays per intended use
No explicit authorization or denial triggers are defined in the reference sections; the policy cites FDA clearances and device intended uses which imply using cleared assays when available.
- Device/assay FDA clearances (eg, Xpert CT/NG) are cited; using cleared assays per intended use is implied.
- Reference sections do not list specific authorization/denial triggers in this extract.
Not covered: NAAT for antimicrobial susceptibility in NG or macrolide resistance in MG
Nucleic acid testing to determine antimicrobial susceptibility in N. gonorrhoeae or macrolide resistance in M. genitalium is explicitly listed as not meeting coverage criteria and may be denied if submitted.
- Policy CC23: NAAT for antimicrobial susceptibility in N. gonorrhoeae or macrolide resistance in M. genitalium DOES NOT MEET COVERAGE CRITERIA.
- Revision history reiterates the addition of CC23 and notes such testing may be denied.
Denial-risk summary: syphilis NAAT and NAAT for susceptibility
Emphasis in the revision history and denial-risk listings reiterates that PCR/NAAT for syphilis and NAAT-based susceptibility testing are likely to be denied if submitted.
- Policy explicitly states PCR/NAAT for syphilis DO NOT MEET COVERAGE and CC23 excludes NAAT for antimicrobial susceptibility.
- This block reiterates denial-risk items for provider awareness.
Clinical Background and Evidence Summary
Sexually transmitted infections encompass bacterial and viral pathogens that can be asymptomatic yet lead to significant morbidity. Chlamydia and gonorrhea can cause pelvic inflammatory disease and reproductive complications; syphilis can progress to neurologic and cardiovascular disease if untreated; Mycoplasma genitalium is associated with urethritis and cervicitis; and HPV is linked to cervical and other anogenital cancers. Public health screening and targeted diagnostic testing aim to identify infections in high‑risk groups and symptomatic patients to prevent complications and transmission.
This policy summarizes clinical recommendations and assay intended uses that inform coverage. NAATs are the preferred diagnostic method for chlamydia and gonorrhea and are supported by FDA‑cleared near‑patient and laboratory platforms (e.g., Cepheid Xpert CT/NG, Abbott Alinity m STI) with validated specimen types. Culture remains important for gonococcal antimicrobial susceptibility testing. For syphilis, serologic two‑test algorithms (treponemal plus nontreponemal) are standard; direct detection methods (darkfield or validated lesion NAAT) are preferred for early lesions when available. CDC guidance informs use of HSV type‑specific serology only in defined clinical scenarios and recommends lesion NAAT/culture for symptomatic herpes.
The evidence citations listed in the reference section support the policy statements and include guideline sources (CDC, USPSTF, NCCN, NICE), assay evaluations, and regulatory documentation. Review these citations for the primary data and guideline language underpinning coverage decisions.
Key Terms and Risk Group Definitions
Policy Changes and Effective Dates
Added 'qualitative' to multiple NAAT references; restored and expanded qualitative NAAT coverage for Trichomonas vaginalis (CC10) with new Note 8 defining high-risk groups; moved individual T. vaginalis testing into this policy and kept multi-organism vaginitis panels in M2057; added CPT code 87800 and removed multiple CPT/HCPCS codes.
Created new CC23 specifying that nucleic acid testing to determine antimicrobial susceptibility in N. gonorrhoeae or macrolide resistance in M. genitalium does not meet coverage criteria; added CPT codes 0483U and 0484U.
Expanded multitarget PCR panel coverage (former CC10 now CC14) to include C. trachomatis, N. gonorrhoeae, T. vaginalis, and M. genitalium; off-cycle coding modification removed CPT 0354U.
The revision history documents material changes to Trichomonas coverage and policy organization. Notably, qualitative NAAT for T. vaginalis was clarified and restored to this policy in specific circumstances, multitarget PCR panel language was expanded to include T. vaginalis and M. genitalium, and several CPT/HCPCS coding changes (including addition of CPT code 87800) were made. These edits reflect both evidence updates and reallocation of vaginitis panel guidance between related policies.
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