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Modifiedmedical mutual - ohioPolicy AHS - G2157

Diagnostic Testing of Common Sexually Transmitted Infections

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Defines medical necessity and coverage criteria for laboratory testing of common STIs (Chlamydia, Gonorrhea, Syphilis, Trichomonas, HSV, HPV, Mycoplasma genitalium) and who is affected (patients seeking diagnosis, screening, follow-up, transplant assessment, PrEP monitoring).

Policy Summary

Payermedical mutual - ohio

PolicyDiagnostic Testing of Common Sexually Transmitted Infections

Policy CodePolicy AHS - G2157

Change TypeMaterial revisions to coverage criteria and coding updates

Effective DateFeb 1, 2026

Last ReviewDec 4, 2024

Next Review DateSep 4, 2025

Key ActionWhen ordering qualitative NAAT for Trichomonas vaginalis, document the specific covered indication (symptomatic status, ≥3 months post‑treatment follow‑up, high‑risk annual screening, HIV status, or sexual assault follow‑up).

SourceLink

POLICY UPDATE CHANGES

Added the adjective 'qualitative' to 'qualitative NAAT' in multiple coverage criteria (CC4, CC7, CC10, CC12, CC15, CC5, CC20.c.) and edited Note 2 for clarity.

Individual organism amplified probe testing for T. vaginalis is now solely addressed in this policy; multi-organism vaginitis panels that test for T. vaginalis remain in policy M2057.

Expanded CC10 to specify coverage of qualitative NAAT for T. vaginalis for symptomatic individuals, follow-up testing ≥3 months after diagnosis, annual screening for high‑risk or HIV‑positive asymptomatic individuals, and follow-up in sexual assault victims; added Note 8 defining high‑risk features.

CC21 and CC22 updated to focus on recommended STI screens for individuals being considered for or actively receiving PrEP; non‑STI screens removed and HIV screening recommendations moved to policy M2116.

CC24 updated to include direct probe detection and/or quantitative NAAT as not meeting coverage criteria for listed microorganisms.

Added CPT code 87800; removed multiple CPT/HCPCS codes and noted off‑cycle additions and deletions (e.g., added 87626 off‑cycle; removed 0500T).

8organisms limited by policy

~20distinct policy points

multiplescreening frequency references

>=10CPT codes removed

NAAT preferredNAAT preferred tests

Coverage Criteria for STI Diagnostic Testing

Syphilis - Meets coverage criteria

Covered when ANY of the following are met:

Syphilis antibody testing coverage: a) Annual screening for asymptomatic persons in a high-risk category (see Note 2) using a standard or reverse algorithm with appropriate initial and confirmatory tests (treponemal and non-treponemal tests); b) Diagnosis for persons presenting with signs and/or symptoms of syphilis (see Note 3); c) Every 3 months for HIV-positive men or men who have sex with men (MSM); d) Treponemal and nontreponemal testing once prior to allogeneic hematopoietic stem cell transplant (donor and recipient) as part of pre-transplant assessment; e) When a nontreponemal test is used as a test of cure (TOC).

Syphilis - Not covered methods

Not covered testing modalities for syphilis:

Syphilis not covered methods: Polymerase chain reaction (PCR) testing and nucleic acid amplification testing (NAAT) for syphilis do not meet coverage criteria.

Policy Summary

Payermedical mutual - ohio

PolicyDiagnostic Testing of Common Sexually Transmitted Infections

Policy CodePolicy AHS - G2157

Change TypeMaterial revisions to coverage criteria and coding updates

Effective DateFeb 1, 2026

Last ReviewDec 4, 2024

Next Review DateSep 4, 2025

SourceLink

On This Page

Chlamydia - Meets coverage criteria

Covered when ANY of the following are met:

Chlamydia NAAT coverage: a) Annual screening for asymptomatic persons in a high-risk category (see Notes 1 & 4); b) Diagnosis for persons presenting with signs and/or symptoms of chlamydial infection; c) Diagnosis of suspected lymphogranuloma venereum (LGV); d) Test-of-cure (TOC) at least three months after initial chlamydial diagnosis; e) Newborn screening, sexual assault follow-up, and annual screening for sexually active individuals <18 years.

Chlamydia - Not covered

Not covered:

Chlamydia serology and excluded methods: Serology testing for Chlamydia (including LGV serology) does not meet coverage criteria. Direct probe detection and quantitative NAAT for listed organisms are not covered per policy exclusions.

Gonorrhea - Meets coverage criteria

Covered when ANY of the following are met:

Gonorrhea NAAT and culture coverage: a) Annual screening for asymptomatic persons in a high-risk category (see Notes 1 & 4); b) Diagnosis for persons presenting with signs and/or symptoms of gonorrhea; c) Test-of-cure (TOC) when indicated; d) Culture for Neisseria gonorrhoeae to determine antimicrobial susceptibility when an individual does not respond to initial treatment; e) Newborn screening, sexual assault follow-up, and annual screening for sexually active individuals <18 years.

Trichomonas - Meets coverage criteria

Covered when ANY of the following are met:

Trichomonas NAAT coverage: a) Symptomatic individuals (see Note 7); b) Follow-up testing a minimum of three months after initial trichomoniasis diagnosis; c) Annual screening for asymptomatic individuals in high-risk groups (see Note 8); d) Annual screening for asymptomatic individuals with HIV infection; e) As part of follow-up in a victim of sexual assault.

Trichomonas - Not covered

Not covered:

Trichomonas excluded tests: Rapid identification of Trichomonas by enzyme immunoassay does not meet coverage criteria.

M. genitalium - Meets coverage criteria for symptomatic only

Covered when ALL of the following (symptomatic) conditions are met:

M. genitalium coverage: Qualitative NAAT for Mycoplasma genitalium meets coverage criteria for symptomatic individuals (e.g., men with recurrent nongonococcal urethritis, women with recurrent cervicitis or suspected PID); screening of asymptomatic individuals does not meet coverage criteria.

Perform resistance testing when available to guide therapy per CDC guidance.

HSV - Coverage and limits

Covered when ANY of the following are met:

HSV coverage and limits: a) Qualitative NAAT (HSV DNA/PCR) from active genital, anal, or mucocutaneous lesions meets coverage criteria for diagnosis; b) Type-specific HSV-2 serologic testing (glycoprotein G2) meets coverage criteria for recurrent or atypical symptoms with negative PCR/culture, for clinical diagnosis when PCR/culture are negative, or when an individual's partner has genital herpes; c) Non-type-specific immunoassay serology for HSV does not meet coverage criteria; d) Screening asymptomatic individuals for HSV-1 or HSV-2 does not meet coverage criteria.

HPV - Cancer-related testing

Covered when ALL of the following are met:

threshold":"","note":"HPV testing for cervical cancer screening is generally recommended for women aged 30–65 per guidelines; see policy cross-references."}

HPV - Not covered uses

Not covered in these situations:

HPV not covered: HPV testing does not meet coverage criteria for: a) routine inclusion as part of general STI/ST D panels for asymptomatic individuals; b) diagnosis of anogenital warts; c) testing for low-risk HPV types; d) general population NAAT to determine HPV status (including routine testing in men or women under age 30).

Multitarget PCR - Conditional coverage

Conditional coverage when ALL targets and indication requirements are met:

Multitarget PCR coverage: Multitarget PCR panels meet coverage criteria only when targets are limited to Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium and the individual meets the relevant clinical indications described in the policy.

Multi-organism vaginitis panels that include other targets or that fall under M2057 are managed per that policy.

PrEP - Required baseline and monitoring tests

Covered when ALL of the following are met (PrEP baseline and monitoring):

PrEP monitoring: a) Prior to initiation and during PrEP, perform triple panel hepatitis B testing (HBsAg, anti-HBs, anti-HBc) per guidance; b) For STI monitoring, perform qualitative NAAT screening for gonorrhea and chlamydia at recommended intervals (every 3 months for MSM; every 6 months for sexually active individuals); c) Blood testing for syphilis screening at recommended intervals (every 3 months for MSM; every 6 months for sexually active individuals).

HIV-specific screening recommendations are addressed in policy M2116 as referenced.

Covered diagnostic testing criteria

Covered testing is aligned to CDC, IUSTI and other guideline recommendations and is appropriate when indication and specimen/site criteria are met:

Syphilis diagnosis: Diagnosis requires use of both a nontreponemal test (RPR or VDRL) and a treponemal test (TPPA/TPHA/EIA/CLIA); direct detection (darkfield or validated PCR) is recommended for lesions and early syphilis; CSF-VDRL and CSF analysis are required when neurosyphilis is suspected.

Reflex quantitative NTT and confirmatory TT guidance applies per algorithm.

Chlamydia and Gonorrhea testing: NAATs are the preferred tests for detection of C. trachomatis and N. gonorrhoeae; collect anatomy-based specimens (first-catch urine, endocervical/vaginal swabs, rectal and pharyngeal swabs) based on exposure site; culture remains necessary for gonococcal antimicrobial susceptibility when indicated.

Retesting/rescreening intervals follow risk-based guidelines (e.g., retest 3 months after treatment).

HSV testing: HSV NAAT from genital, anal, or mucocutaneous lesions is the most sensitive diagnostic test; type-specific serology is useful in select scenarios but routine serologic screening of asymptomatic persons is not recommended.

M. genitalium testing: Use FDA-cleared NAATs for M. genitalium on appropriate specimens (urine, urethral/meatal, endocervical or vaginal swabs); perform resistance testing when available to guide therapy; do not screen asymptomatic persons routinely.

Culture is not practical clinically due to slow growth.

Trichomonas testing: Use NAAT or other FDA-cleared molecular assays for symptomatic women; consider annual screening in high-prevalence settings or for high-risk asymptomatic women; retest sexually active women approximately 3 months after treatment due to high reinfection rates.

Wet mount microscopy has low sensitivity and should be supplemented by molecular testing when possible.

HPV testing is appropriate for cervical cancer screening in eligible persons (typically women aged 30–65) per guideline intervals; HPV testing is not recommended for diagnosis of anogenital warts or routine STI screening in asymptomatic individuals, particularly men and women under 30.

BD Onclarity and other FDA-cleared assays have specified intended uses and specimen requirements.

Syphilis: Reflex and confirmatory testing

Covered when the following testing/reflex steps are performed according to screening results:

Syphilis algorithm - treponemal-first: If a treponemal test (TT) is used alone as primary screening and is positive, perform a reflex quantitative non-treponemal test (NTT) on the same serum reaching at least a 1:8 to 1:16 dilution; if TT positive and NTT negative with no suspicion of very early syphilis, repeat both tests after 1 month.>= 1:8 dilution

Reflex testing should be performed on the same serum sample when possible.

Syphilis algorithm - nontreponemal-first: If a non-treponemal test (NTT) is used alone as primary screening and is positive, follow with a reflex treponemal test (TT) on the same serum; if the initial NTT was nonquantitative, repeat quantitatively.

When both TT and NTT are used as primary screens, ensure the NTT is quantitative if not initially performed.

NAAT-preferred organism testing and site-specific sampling

Covered when testing follows organism- and site-specific NAAT guidance:

Chlamydia and Gonorrhea NAAT: Use NAAT (DNA or RNA) as the preferred test for symptomatic and asymptomatic sexually active individuals; obtain specimens from exposed anatomic sites (first-catch urine, vaginal/endocervical swabs for urogenital infection; rectal and pharyngeal swabs for extragenital exposure) as appropriate; culture is indicated when antimicrobial susceptibility testing is required (e.g., treatment failure).

Consult individual assay product inserts for accepted specimen types.

HSV lesion testing: For symptomatic genital lesions, perform HSV DNA detection (NAAT/PCR) rather than culture; consider type-specific serology when lesion testing is not possible or for counseling reasons, recognizing seroconversion timing (~90 days).

M. genitalium specimen guidance: NAAT for M. genitalium can be performed on urine, cervical, vaginal, urethral or meatal swabs and endometrial biopsies per available FDA-cleared assays.

Resistance testing, when available, is recommended to guide therapy.

HPV testing recommendations

Covered/Not covered decisions regarding HPV testing:

Anogenital warts: Diagnosis of anogenital warts is usually by visual inspection; HPV testing is not recommended for AGW because it does not alter clinical management.

Cervical cancer screening: HPV testing for high-risk oncogenic types is supported when used for cervical cancer screening or cancer-related diagnostic/therapeutic decisions in appropriate patients (typically women aged 30 and older) per guideline recommendations.

BD Onclarity and other assays have specific intended uses; positive high-risk results may prompt referral (e.g., colposcopy).

Guideline-concordant indications

Coverage aligns with evidence-based guideline recommendations; tests are supported when indicated per organism and clinical scenario:

Guideline-aligned coverage: Testing is appropriate when consistent with cited guideline recommendations (e.g., NAAT for chlamydia and gonorrhea in indicated populations; two-test serologic algorithm for syphilis; NAAT/PCR for HSV lesions).

References include CDC, IUSTI, BASHH, AAP, USPSTF, NCCN as cited in the policy.

CC10 - Qualitative NAAT for Trichomonas vaginalis

Qualitative NAAT for T. vaginalis MEETS COVERAGE CRITERIA in the following situations:

CC10

CC10a: For symptomatic individuals (see Note 7).
Refer to Note 7 for symptom definitions.
CC10b: Follow-up testing a minimum of three months after initial trichomoniasis diagnosis.>= 3 months
CC10c: Annual screening for asymptomatic individuals belonging to a high-risk group (see Note 8).annual
See Note 8 for high-risk definition.
CC10d: Annual screening for asymptomatic individuals who have an HIV infection.annual
CC10e: As part of follow-up in a victim of sexual assault.

CC10 — T. vaginalis Qualitative NAAT indications

CC10: Qualitative NAAT for T. vaginalis MEETS COVERAGE CRITERIA in the following situations:

CC10a: a) For symptomatic individuals (see Note 7).

See Note 7 for symptomatic criteria.

CC10b: b) Follow up testing a minimum of three months after initial trichomoniasis diagnosis.>= 3 months

CC10c: c) Annual screening for asymptomatic individuals belonging to a high-risk group (see Note 8).annual

Note 8 defines high-risk groups.

CC10d: d) Annual screening for asymptomatic individuals who have an HIV infection.annual

CC10e: e) As a part of follow-up in a victim of sexual assault.

Tests explicitly listed as not meeting coverage criteria include PCR/NAAT for syphilis, serology for Chlamydia/LGV, rapid Trichomonas enzyme immunoassay, and nucleic acid testing to determine antimicrobial susceptibility in N. gonorrhoeae or macrolide resistance in M. genitalium. Submission of these modalities may trigger claim denial when provided for the excluded indications.

BD Onclarity high-risk HPV results should not be used to defer indicated diagnostic procedures: a positive result for HPV genotypes 16 and/or 18 should prompt referral to colposcopy per the manufacturer's intended use and clinical guidance. Onclarity may be used adjunctively with cytology in women ≥30 years to guide management but does not replace clinician assessment or recommended follow-up.

Routine serologic screening for genital herpes in asymptomatic adolescents and adults, including pregnant persons, is not recommended due to a high rate of false-positive results and potential psychosocial harms. Type-specific HSV serology may be useful in selected clinical scenarios (see policy) but is not appropriate for general asymptomatic screening.

Screening asymptomatic persons for Mycoplasma genitalium is not recommended; qualitative NAAT for M. genitalium is covered only for symptomatic individuals or other specified clinical indications. Likewise, routine HPV testing in men and in women under age 30 as part of general STI screening is not recommended and does not meet coverage criteria.

HPV testing is covered when used for the diagnosis or management of cancer (for example, p16 immunohistochemistry or NAAT for high-risk HPV in appropriate oncology settings). HPV testing is not indicated for diagnosis of anogenital warts or as part of routine STI screening in asymptomatic men or younger women; it does not alter clinical management in these contexts.

HPV testing is not recommended for general STI screening in asymptomatic men, adolescents, or women under age 30. Testing for oncogenic HPV is appropriate only in the specified cervical cancer screening age range and oncologic indications described elsewhere in the policy.

Multi-organism vaginitis panels that include Trichomonas vaginalis are addressed under the payer's vaginitis policy (M2057). This policy instead covers individual organism testing for T. vaginalis where indicated; multi-organism panels with T. vaginalis remain managed per M2057.

Multi-organism vaginitis panels that also test for T. vaginalis continue to be covered under policy M2057. This document limits coverage language to individual organism testing for T. vaginalis and refers multi-target vaginitis panel questions to the referenced policy.

Per the updated coverage criteria (CC24), direct probe detection and/or quantitative NAAT for the listed organisms (including Chlamydia trachomatis, Neisseria gonorrhoeae, HSV-1/2, HPV, and Treponema pallidum) does not meet coverage criteria and should not be submitted for coverage in those indications.

The policy reiterates that screening asymptomatic individuals for HSV-1/HSV-2 and routine HPV testing as part of general STI panels in asymptomatic people do not meet coverage criteria. NAAT-based testing is preferred for symptomatic lesion diagnosis and other guideline-supported indications, while NAAT-based antimicrobial susceptibility testing for N. gonorrhoeae and macrolide resistance in M. genitalium is not covered.

Antigen-detection point-of-care tests for Chlamydia trachomatis have substantially lower sensitivity compared with laboratory NAATs (pooled sensitivities for cervical, vaginal, and male urine POCTs ~53%, 37%, and 63% respectively) and are not recommended as screening tests due to inadequate sensitivity.

HPV testing of male partners is not an approved or recommended use; routine HPV testing for male partners or for diagnosis of genital warts is not recommended and therefore is not an indicated coverage use.

Serologic testing for HSV is not routinely recommended in asymptomatic patients because of false-positive rates and limited benefit; type-specific HSV serology may be useful selectively (for example, in partners of persons with genital herpes, pregnant women in specific circumstances, or individuals with recurrent/atypical disease).

Routine asymptomatic screening is limited per guideline-based recommendations: NAAT screening for chlamydia and gonorrhea is generally recommended annually for sexually active women <25 and for other high-risk persons, with more frequent (every 3–6 months) screening in higher-risk groups (e.g., MSM); routine HPV testing for general STI screening in asymptomatic people is not supported outside defined cervical cancer screening indications.

Direct probe detection and/or quantitative NAAT modalities are explicitly listed in the policy (CC24) as not meeting coverage criteria for specified organisms. These methods should not be used in place of guideline-recommended qualitative NAATs or serologic algorithms where those are the standard of care.

The revision restates that direct probe detection and quantitative NAAT for the named organisms do not meet coverage criteria (per CC24). Providers submitting these test types for the excluded organisms risk noncoverage.

Procedure Codes and Coding Guidance

M. genitalium testingmixed

FDA-cleared NAAT (unspecified CPT)	NAATs for M. genitalium (urine and urethral, penile meatal, endocervical, vaginal swabs)
87563	Infectious agent detection by nucleic acid (DNA or RNA); Mycoplasma genitalium, amplified probe technique.
0484U	Mycoplasma genitalium macrolide resistance (23S rRNA point mutation) algorithm (Proprietary).

Syphilis serologymixed

TT (TPHA/TPPA/EIA/ELISA/CLIA)	Treponemal tests for syphilis
NTT (RPR/VDRL)	Nontreponemal serologic tests for syphilis, preferably quantitative
86592	Syphilis test, non-treponemal antibody; qualitative (eg, VDRL, RPR, ART).
86593	Syphilis test, non-treponemal antibody; quantitative.
86780	Antibody; Treponema pallidum.
0064U	Antibody, Treponema pallidum, total and rapid plasma reagin (RPR), immunoassay, qualitative (Proprietary).
0065U	Syphilis test, non-treponemal antibody, immunoassay, qualitative (RPR) (Proprietary).
0210U	Syphilis test, non-treponemal antibody, immunoassay, quantitative (RPR) (Proprietary).

Chlamydia/Gonorrhea/Trichomonas testingmixed

NAAT (unspecified CPT)	NAATs for Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis; specimen site per exposure (urine, vaginal, endocervical, rectal, pharyngeal)
Culture (unspecified CPT)	Bacterial culture for N. gonorrhoeae when antimicrobial susceptibility or treatment failure evaluation is needed
87490	Chlamydia trachomatis, direct probe technique.
87491	Chlamydia trachomatis, amplified probe technique.
87492	Chlamydia trachomatis, quantification.
87590	Neisseria gonorrhoeae, direct probe technique.
87591	Neisseria gonorrhoeae, amplified probe technique.
87592	Neisseria gonorrhoeae, quantification.
87661	Trichomonas vaginalis, amplified probe technique.
87808	Trichomonas vaginalis antigen detection by immunoassay with direct optical observation.

Herpes testingmixed

HSV NAAT (unspecified CPT)	HSV nucleic acid amplification testing from lesions; more sensitive than culture
HSV type-specific serology (unspecified CPT)	Type-specific HSV IgG antibody testing in selected scenarios
87528	Herpes simplex virus, direct probe technique.
87529	Herpes simplex virus, amplified probe technique.
87530	Herpes simplex virus, quantification.
86694	Antibody; herpes simplex, non-specific type test.
86695	Antibody; herpes simplex, type 1.
86696	Antibody; herpes simplex, type 2.

Syphilis testing algorithms (treponemal and non-treponemal groups)mixed

TT (TPHA/TPPA/EIA/ELISA/CLIA)	Treponemal tests (e.g., TPHA, TPPA, EIA/ELISA/CLIA)
NTT (RPR/VDRL)	Nontreponemal tests (RPR or VDRL), preferably quantitative; reflex quantitative NTT target at least 1:8 to 1:16 dilution.

NAAT-preferred tests (Chlamydia, Gonorrhea, M. genitalium, HSV lesion PCR)mixedCovered

NAAT (unspecified CPT)	Organism-specific NAATs preferred for C. trachomatis, N. gonorrhoeae, M. genitalium, and HSV lesion PCR
87563	Mycoplasma genitalium, amplified probe technique.
87491	Chlamydia trachomatis, amplified probe technique.
87591	Neisseria gonorrhoeae, amplified probe technique.
87529	Herpes simplex virus, amplified probe technique.
87661	Trichomonas vaginalis, amplified probe technique.

HPV / Anogenital warts testing (visual diagnosis; HPV testing not recommended for AGW)mixedNot Covered

visual diagnosis	Anogenital warts are usually diagnosed by visual inspection; HPV testing is not recommended for AGW.
HPV testing for AGW (unspecified CPT)	HPV testing not recommended for diagnosis of anogenital warts or routine STI screening; see cervical cancer screening guidance for HPV use.
87623	HPV, low-risk types.
87624	HPV, high-risk types, pooled result.
87625	HPV, types 16 and 18 only.
87626	HPV, separately reported high-risk types and pooled results.

Listed CPT Codes (serology, culture, susceptibility)CPT

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.

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Listed CPT Codes (NAAT/antigen/HPV/trichomonas)CPT

87340	Infectious agent antigen detection by immunoassay technique; HBsAg (example listed).
87490	Infectious agent detection by nucleic acid (DNA or RNA); Chlamydia trachomatis, direct probe technique.
87491	Chlamydia trachomatis, amplified probe technique.
87492	Chlamydia trachomatis, quantification.
87528	Herpes simplex virus, direct probe technique.
87529	Herpes simplex virus, amplified probe technique.
87530	Herpes simplex virus, quantification.
87563	Mycoplasma genitalium, amplified probe technique.
87590	Neisseria gonorrhoeae, direct probe technique.
87591	Neisseria gonorrhoeae, amplified probe technique.

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Listed CPT Codes (multiplex and other NAAT/antigen)CPT

87797	Infectious agent detection by nucleic acid, not otherwise specified; direct probe technique, each organism.
87798	Infectious agent detection by nucleic acid, not otherwise specified; amplified probe technique, each organism.
87799	Infectious agent detection by nucleic acid, not otherwise specified; quantification, each organism.
87800	Infectious agent detection by nucleic acid (DNA or RNA), multiple organisms; direct probe(s) technique.
0402U	Multiplex STI assay (Chlamydia, Gonorrhoeae, Trichomonas, Mycoplasma genitalium) - Abbott Alinity m STI Assay.

Listed CPT Codes (IHC/ICC)CPT

88341	Immunohistochemistry or immunocytochemistry, per specimen; each additional single antibody stain procedure.
88342	Immunohistochemistry or immunocytochemistry, per specimen; initial single antibody stain procedure.
88344	Immunohistochemistry or immunocytochemistry, per specimen; each multiplex antibody stain procedure.

Proprietary / HCPCS Level II / Proprietary CPT Category IIsmixed

0064U	Antibody, Treponema pallidum, total and RPR, immunoassay, qualitative (BioPlex 2200 Syphilis Total & RPR Assay).
0065U	Syphilis test, non-treponemal antibody, immunoassay, qualitative (BioPlex 2200 RPR Assay).
0096U	HPV, high-risk types, male urine (Proprietary: Molecular Testing Labs/Roche Cobas).
0210U	Syphilis test, non-treponemal antibody, immunoassay, quantitative (BioPlex 2200 RPR Assay - Quantitative).
0402U	Multiplex STI assay (Chlamydia, Gonorrhoeae, Trichomonas, Mycoplasma genitalium) - Abbott Alinity m STI Assay.
0455U	Multiplex STI assay (Chlamydia, Gonorrhoeae, Trichomonas) - Abbott Alinity m STI Assay.
0463U	Oncology (cervix), mRNA gene expression profiling of 14 biomarkers (Proofer '7 HPV mRNA E6 and E7 Biomarker Test).
0483U	Neisseria gonorrhoeae ciprofloxacin resistance (gyrA S91F point mutation) susceptibility algorithm.
0484U	Mycoplasma genitalium macrolide resistance (23S rRNA point mutation) algorithm.
G0499	G0499.

Added CPT codesCPT

87800

Infectious agent detection by nucleic acid (DNA or RNA), multiple organisms; direct probe(s) technique. (Added per revision history).

Removed CPT/HCPCS codesmixedNot Covered

82565
82575
84702
84703
86701
86702
86703
86705
86803
86804

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Off-cycle added CPT codesCPT

87626

HPV, separately reported high-risk types and pooled results. (Off-cycle added effective 1/1/2025).

Deleted CPT codesCPTNot Covered

0500T

deleted code

Revised CPT code descriptionsCPT

87624

description revised effective 1/1/2025

Screening frequencies — examples

Annual screening examplesAnnual screening for asymptomatic persons in high-risk groups (e.g., sexually active women <25, high‑risk MSM/others) is supported.

Three-month interval exampleSyphilis serology and PrEP-related NAAT: once every 3 months for HIV‑positive men or MSM and for MSM on PrEP.

Three- to six-month interval exampleMore frequent (every 3–6 months) screening recommended for higher‑risk groups such as adolescents at increased risk or MSM per guideline references.

PrEP monitoring cadenceFor PrEP users: NAAT screening for chlamydia/gonorrhea every 3 months for MSM and every 6 months for sexually active individuals; syphilis blood testing aligned similarly.

Reflex quantitative NTT dilution target

Required reflex dilution targetWhen a treponemal test (TT) is used alone and is positive, perform a reflex quantitative non‑treponemal test (NTT) on the same serum reaching at least a 1:8 to 1:16 dilution.

Repeat testing when discordantIf TT positive and NTT negative with no suspicion of very early syphilis, repeat both tests after 1 month.

If NTT used firstIf NTT alone is used as primary screening and is positive, follow with a reflex TT on the same serum and ensure quantitative NTT if not initially done.

Age-based HPV screening

Age threshold for cervical screeningHPV testing for cervical cancer screening is recommended for women aged 30 years and older per cited guidance.

Not routine in men or younger womenHPV testing is not recommended for routine STI screening in men or for women under age 30 as part of general STI panels.

Use in cancer assessmentHR‑HPV testing or p16 IHC meets coverage when used in diagnosis/assessment of cancer or cancer therapy contexts.

Chlamydia/Gonorrhea screening frequency

Annual screening — young womenAnnual screening for sexually active women under age 25 is recommended per CDC/AAP guidance.

Higher‑risk personsAnnual screening also indicated for other persons who meet high‑risk criteria (see policy notes).

Increased frequency for high‑risk groupsFor higher‑risk groups (e.g., MSM, persons with multiple partners), screening every 3–6 months is recommended depending on risk per guideline sources.

Prior authorization headline and guidance

Prior authorization headlineNo explicit prior authorization requirements are specified in this excerpt; follow related AHS lab policies and payer procedures and verify at the payer lab policy URL.

Check payer lab policyThis document is subject to the payer lab policy disclaimer — always verify the most current version at https://www.medmutual.com/LabPolicies for any PA requirements.

Coding updates — verify PA when neededCertain CPT codes were added, removed, or revised (e.g., added 87800, off‑cycle 87626, revised 87624); verify code‑specific prior authorization requirements prior to submission.

Provider Actions, Documentation & Billing Considerations

Prior Authorization

Prior authorization: none stated in policy excerpt

No explicit prior authorization requirements are specified in this policy excerpt; follow related AHS lab policies and payer procedures for any required authorizations.

Prior Authorization

Check payer lab policy for PA and current version

This document is subject to the payer's lab policy disclaimer and may change; check the payer's Lab Policies website for the current policy and any prior authorization requirements before submitting tests for coverage.

Note

Consider near-patient NAATs for CT/NG to support same-day management

Consider using rapid near-patient NAATs (e.g., GeneXpert/Xpert CT/NG) when available because near-patient NAATs demonstrate high sensitivity and specificity and can alter management by reducing undertreatment and overtreatment.

GeneXpert/Xpert CT/NG provides results in ~90 minutes and supports same-day management (Chunk 34).
Pooled evidence shows near-patient NAAT sensitivity >98% and improved clinical management versus standard care (Chunks 43, 46).

Documentation Required

Use FDA‑cleared NAAT and resistance testing for M. genitalium

Order Mycoplasma genitalium testing using an FDA-cleared NAAT for the appropriate specimen types; when available, perform resistance testing and use results to guide therapy.

FDA-cleared NAATs for M. genitalium are validated for urine, urethral/meatal, endocervical, and vaginal swabs (Chunk 61).
CDC recommends resistance testing when available and using results to guide treatment (Chunk 61).

Documentation Required

Perform same‑serum reflex quantitative NTT after positive treponemal screen

When a treponemal-only screening test is positive, perform a reflex quantitative non-treponemal test on the same serum reaching at least a 1:8 to 1:16 dilution; repeat both tests after 1 month if TT positive and NTT negative with no suspicion of very early syphilis.

Reflex quantitative NTT should be performed on the same serum and reach at least 1:8 to 1:16 dilution (Chunk 72).
If TT positive and NTT negative with no suspicion of very early syphilis, repeat both tests after 1 month (Chunk 72).

Billing Rule

Refer to policy code list for billing and PA lookups

The policy lists multiple CPT/HCPCS and proprietary codes in its code tables; use these listed codes for billing and to inform any prior authorization lookups.

See listed CPT/HCPCS and Proprietary codes in the policy's code sections (Chunks 101–106).
Use the policy code list when preparing claims and checking for any code-specific PA requirements.

Prior Authorization

Verify prior authorization with payer — none specified here

No explicit prior authorization requirements are stated in this excerpt; verify any PA requirements with the payer or applicable AHS lab policy before ordering tests.

Billing Rule

Verify code changes and related PA before claim submission

Coding updates were made (codes added, removed, or revised); verify code-specific prior authorization requirements and use the current codes when submitting claims.

Policy revision history notes added CPT code 87800 and off-cycle addition of CPT 87626; multiple codes were removed and some descriptions revised (Chunk 128).
Confirm correct, current CPT/HCPCS codes and any PA implications prior to claim submission.

Documentation Required

Document clinical indication and patient risk to support coverage

Document the clinical indication and patient risk status when ordering STI tests (e.g., high‑risk screening, symptomatic diagnosis, test of cure, transplant screening, sexual assault follow‑up, or PrEP monitoring) to support coverage.

Syphilis: document high‑risk status, symptoms, HIV status, transplant evaluation, or TOC indication (Chunk 4).
Chlamydia/gonorrhea/trichomonas: document symptomatic status, high‑risk screening, TOC timing, or sexual assault follow‑up as applicable (Chunks 5, 6).

Documentation Required

Record specimen type and indication when ordering FDA‑cleared NAATs

When ordering FDA‑cleared assays (e.g., BD Onclarity, Cepheid Xpert CT/NG, Abbott Alinity m STI), document the specimen type and indication because assays have specified specimen types and intended uses.

BD Onclarity is indicated for cervical swabs and reports specific HPV genotypes (Chunk 32).
Cepheid Xpert CT/NG supports urine, patient-collected vaginal, clinician-collected endocervical, pharyngeal and rectal swabs (Chunk 34).
Abbott Alinity m STI lists endocervical, vaginal, and urine specimen types among others (Chunk 35).

Documentation Required

Document ulcer evaluation including syphilis serology, darkfield or lesion NAAT

For persons with genital, anal, or perianal ulcers, document evaluation including syphilis serology and, if available, darkfield exam or lesion NAAT; include HSV NAAT or culture and type‑specific HSV serology when indicated.

CDC recommends syphilis serology plus darkfield or lesion NAAT if available for ulcer evaluation (Chunk 54).
Document HSV NAAT or culture and type‑specific serology in appropriate clinical contexts (Chunk 55).

Documentation Required

Include reflex quantitative NTT and confirmatory TT per syphilis algorithm

When using syphilis testing algorithms, include reflex quantitative non‑treponemal testing (RPR/VDRL) and confirmatory treponemal testing (TPPA/TPHA) per the algorithm and document quantitative titers when indicated.

Reflex quantitative NTT on same serum is required when TT is used alone for primary screening (Chunk 72).
If NTT was used alone and positive, follow with reflex TT on the same serum or repeat quantitatively (Chunk 72).

Documentation Required

Ensure same‑serum reflex quantitative NTT at specified dilution

Ensure reflex quantitative non‑treponemal testing is performed on the same serum and reaches the specified dilution target (at least 1:8 to 1:16) when required by the algorithm.

Policy specifies reflex quantitative NTT should reach at least a 1:8 to 1:16 dilution on the same serum (Chunk 72).

Documentation Required

Document LDT validation and CLIA compliance for in‑house tests

If you plan to use laboratory‑developed tests (LDTs), ensure documentation supports LDT validation and CLIA compliance because LDTs are regulated as high‑complexity tests under CLIA.

LDTs are regulated by CMS under CLIA as high‑complexity tests and require laboratory validation and documentation (Chunk 100).

Documentation Required

Document covered indication when ordering qualitative NAAT for T. vaginalis

When ordering qualitative NAAT for T. vaginalis under expanded CC10 indications, document the covered indication (symptomatic, follow‑up ≥3 months, annual high‑risk screening, annual screening for persons with HIV, or sexual assault follow‑up).

CC10 lists covered indications including symptomatic testing and follow‑up ≥3 months (Chunk 6 and revision Chunk 127).
Note 8 defines high‑risk groups referenced for annual screening (Chunk 127).

Documentation Required

Support T. vaginalis NAAT orders with specific documentation per CC10

Documentation supporting T. vaginalis NAAT orders should indicate symptomatic status, timing since prior diagnosis (≥3 months), high‑risk status per Note 8, HIV status, or sexual assault follow‑up context to meet CC10 expectations.

CC10 requires documentation for symptomatic testing and timing for follow‑up testing ≥3 months (Chunk 6).
Note 8 enumerates high‑risk features to support annual screening (Chunk 127).

Denial Risk

Avoid ordering tests explicitly listed as not meeting coverage criteria to prevent denial

Submitting tests explicitly listed as not meeting coverage criteria (for example, PCR/NAAT for syphilis; direct probe detection or quantitative NAAT for listed organisms; nucleic acid antimicrobial susceptibility testing for N. gonorrhoeae or macrolide resistance in M. genitalium) may trigger denial.

PCR/NAAT for syphilis is stated as not meeting coverage criteria (Chunk 5).
CC23–24 list nucleic acid susceptibility testing and direct probe/quantitative NAAT for specific organisms as not meeting coverage criteria (Chunk 9).

Note

Confirm current policy version on payer lab policies site

Verify you are following the most current policy version at the payer lab policy URL; failure to adhere to the current policy could risk noncompliance or coverage issues.

The policy states the document is subject to the disclaimer and to always verify the most current version at the payer Lab Policies site (Chunks 2, 20).

Denial Risk

Risk of nonconcordance and denial if non‑NAAT methods used for CT/NG

Using non‑NAAT methods when CDC and USPSTF recommend NAAT (for chlamydia and gonorrhea) could result in nonconcordant, guideline‑discordant testing choices and increase risk of coverage denial.

USPSTF recommends chlamydia and gonorrhea testing using NAATs (Chunk 51).
POCT antigen tests have substantially lower sensitivity than near‑patient NAATs (Chunk 43).

Denial Risk

Perform both NTT and TT for syphilis—one test alone is insufficient

Do not rely on a single serologic test for syphilis diagnosis; use both a nontreponemal and a treponemal test because using only one test can yield false‑negative or false‑positive results.

CDC guidance states a presumptive syphilis diagnosis requires use of both NTT and TT; use of only one type is insufficient and can result in false results (Chunk 56).
Policy details reflex testing algorithms to ensure both test types are performed and interpreted correctly (Chunk 72).

Denial Risk

Risk of denial if reflex confirmatory testing is not performed

Failure to perform recommended reflex confirmatory testing (for example, reflex quantitative NTT after a positive treponemal‑only screen) may lead to unsupported or incomplete laboratory documentation and affect coverage determination.

Policy requires reflex quantitative NTT on same serum when TT used alone and prescribes repeat testing when discordant (Chunk 72).

Denial Risk

Government policies (LCDs/NCDs) take precedence over this policy

When there is a conflict between this policy and an applicable government policy (LCD/NCD), the government policy will take precedence and may dictate coverage decisions.

Denial Risk

Use M2057 for multi‑organism vaginitis panels including T. vaginalis to avoid denial

Ordering multi‑organism vaginitis panels that include T. vaginalis under this policy rather than policy M2057 may risk denial; multi‑organism vaginitis panels with T. vaginalis are directed to M2057.

Policy limits T. vaginalis panel responsibility and directs multi‑organism vaginitis panels that test for T. vaginalis to policy M2057 (Chunks 2, 127).

Denial Risk

Denial risk: direct probe detection or quantitative NAAT for listed organisms

Coverage does not meet criteria for direct probe detection and/or quantitative NAAT for the listed microorganisms (per CC24); submitting those test types may result in claim denials.

CC24 explicitly states direct probe detection and/or quantitative NAAT for listed organisms does not meet coverage criteria (Chunk 9).
Revision history clarifies CC24 was updated to include direct probe detection as not meeting coverage criteria (Chunk 127).

Definitions and Background

Sexually transmitted infections (STIs) encompass bacterial, viral, and other pathogens transmitted through sexual contact and can lead to serious sequelae including pelvic inflammatory disease, infertility, and neurologic or cardiac complications (e.g., from syphilis). Public health implications are substantial; guideline-based testing focuses resources on populations and indications where testing improves outcomes.

STIs covered

STIs includedC. trachomatis; N. gonorrhoeae; T. pallidum; T. vaginalis; HSV; HPV; M. genitalium

Scope limitationPolicy excludes other infections and refers to M2057 for multi‑organism vaginitis panels that include T. vaginalis

Policy useThese organisms are those to which the coverage criteria in this policy are limited

Allo‑HCT (definition and context)

DefinitionAllogeneic haematopoietic stem cell transplantation (Allo‑HCT): transplantation using donor hematopoietic stem cells; used in transplant‑related screening contexts

Context of useTreponemal and nontreponemal testing once prior to transplant as part of donor/recipient assessment for allo‑HCT

AbbreviationAllo‑HCT = allogeneic haematopoietic stem cell transplantation

NAAT — definition and role

DefinitionNucleic acid amplification testing (NAAT): molecular assays (e.g., PCR, TMA, SDA) that detect pathogen nucleic acid and are the preferred tests for chlamydia and gonorrhea

ExamplesMolecular methods include PCR, transcription‑mediated amplification (TMA), and strand displacement amplification (SDA)

Preferred useRecommended as first‑line testing for symptomatic and asymptomatic screening where available

PID — definition

DefinitionPelvic inflammatory disease (PID): clinical syndrome related to ascending STI infections such as chlamydia, gonorrhea, and M. genitalium

Clinical relevancePID is a complication prompting diagnostic testing and treatment as indicated

Associated organismsCommonly associated with C. trachomatis, N. gonorrhoeae, and M. genitalium per policy text

HR‑HPV — high‑risk HPV types / BD Onclarity

HR‑HPV definitionHigh‑risk (oncogenic) HPV types detectable by FDA‑cleared assays (BD Onclarity identifies types including 16, 18, 45)

Use caseHR‑HPV testing meets coverage criteria when used for diagnosis/assessment of cancer or cancer therapy (e.g., cervical cancer screening)

Assay exampleBD Onclarity HPV Assay can detect high‑risk genotypes (16, 18, 45) and may be used adjunctively in women ≥30

NAAT — molecular assay examples

Molecular assay examplesNAAT molecular assay types include PCR, transcription‑mediated amplification (TMA), and strand displacement amplification (SDA)

Performance notePooled studies of these assays show high specificity (>97%) and strong analytic validity for urine and swab specimens

ApplicationUsed for detection of C. trachomatis, N. gonorrhoeae, M. genitalium and lesion HSV where available

POCT — definition and sensitivity caveat

POCT definitionPoint‑of‑care test (POCT): rapid antigen or antibody assays performed near the patient, often with lower sensitivity than laboratory NAATs

Sensitivity caveatPOCT antigen tests for chlamydia/gonorrhea have substantially lower sensitivity (e.g., pooled sensitivities 37–63% across specimen types) compared to near‑patient NAAT (>98%)

RolePOCTs may be useful where rapid results are needed but are not recommended as replacements for laboratory NAAT for screening

TT — treponemal test

TT definitionTreponemal test (TT): assays such as TPHA, TPPA, EIA/ELISA/CLIA used to detect treponemal antibodies for syphilis

Role in algorithmTT may be used as primary screening (with reflex quantitative NTT) or as confirmatory test depending on algorithm

ExamplesTPHA, TPPA, EIA/ELISA/CLIA, immunoblots

NTT — non‑treponemal test

NTT definitionNon‑treponemal test (NTT): assays such as RPR or VDRL used for syphilis screening and to quantify disease activity (titers)

Quantitative usePreferably performed quantitatively to provide titers for diagnosis, monitoring, and test‑of‑cure

Role in algorithmRequired as reflex quantitative test on same serum when TT is used alone as primary screen

Treponemal test — TT

TT (synonym)Treponemal test — see definition (TPHA/TPPA/EIA/CLIA) used for syphilis detection

Use with NTTTT results should be interpreted in conjunction with NTT and reflex testing per algorithm

Confirmatory roleConfirmatory TT of a different type may be used for counselling/notification though limited treatment impact

Non‑treponemal test — NTT

NTT (synonym)Non‑treponemal test (NTT) — e.g., RPR or VDRL, may be quantitative to provide titers used for diagnosis and monitoring

Test‑of‑cureNTT used as TOC to monitor titer decline after therapy

Reflex requirementIf TT used alone, reflex quantitative NTT should be performed to at least 1:8–1:16 dilution

NAAT — preferred due to high sensitivity/specificity

NAAT preferredNAAT is preferred for chlamydia, gonorrhea, M. genitalium and HSV lesion testing due to superior sensitivity and specificity

Specimen guidanceObtain anatomy‑based specimens (vaginal/cervical/urine; rectal/pharyngeal for extragenital exposure) per organism guidance

Culture roleCulture remains necessary for gonorrhea antimicrobial susceptibility when treatment failure is suspected

NAAT — recommended for chlamydia and gonorrhea

Chlamydia/gonorrhea recommendationNAAT is recommended when available for chlamydia and gonorrhea because it is more sensitive than culture for many specimen sites

Anatomic sitesUse NAAT on urogenital and extragenital sites as indicated (rectal, pharyngeal) for exposure‑based testing

Clinical implicationNear‑patient NAATs (e.g., GeneXpert) may support same‑day management where available

LDT — laboratory‑developed test

LDT definitionLaboratory‑developed test (LDT): tests developed and validated by a laboratory and regulated under CLIA as high‑complexity tests; not necessarily FDA‑cleared/approved

Regulatory noteLDTs must meet CLIA validation and documentation requirements when used clinically

Use cautionDocument validation and CLIA compliance when ordering or using LDTs

Note 8 — High‑risk for Trichomoniasis

Note 8 titleNote 8: High‑risk for Trichomoniasis

Definition summaryHigh‑risk includes care in high‑prevalence settings (STI clinics, correctional facilities), multiple sexual partners, exchanging sex for money/drugs, previous or concurrent STI, drug misuse, history of incarceration, and being sexually active with HIV

Use in CC10Note 8 is referenced to define high‑risk for annual T. vaginalis screening under CC10

High‑risk for Trichomoniasis — details (Note 8)

High‑risk componentsIncludes: receiving care in high‑prevalence settings (STI clinics, correctional facilities); multiple sexual partners; exchanging sex for money/drugs; previous/concurrent STI; drug misuse; history of incarceration; sexually active individuals with HIV

Intended useApplied to determine eligibility for annual asymptomatic T. vaginalis screening (CC10.c)

ReferenceNew Note 8 added in revision history to clarify high‑risk definition

Policy Revisions and Change Log

2025-09-04material_revisionLatest

Operative wording tightened: added 'qualitative' to multiple coverage criteria (CC4, CC7, CC10, CC12, CC15, CC5, CC20.c.), CC10 rewritten with expanded indications for qualitative NAAT for T. vaginalis and new Note 8 defining high-risk groups; CC21/CC22 narrowed for PrEP-related screening and CC24 updated to explicitly include direct probe detection/quantitative NAAT as not covered.

2024-12-04coding_update

Off-cycle coding modification: added CPT code 87626 (effective 2025-01-01); removed CPT code 0500T (deleted effective 2025-01-01); revised description for CPT 87624 (effective 2025-01-01).

2024-09-04coding_and_list_change

Added CPT code 87800 and removed multiple CPT/HCPCS codes (including 82565, 82575, 84702, 84703, 86701–86705, 86803, 86804, 87660, G0432, G0433, G0435, G0472, G0475, S3645) as recorded in the revision history.

Recent coding updates in the revision history include the addition of CPT code 87800, an off‑cycle addition of CPT 87626 (effective 1/1/2025), removal of multiple CPT/HCPCS codes (including 82565, 82575, 84702, 84703, 86701–86705, 86803–86804, 87660, G0432, G0433, G0435, G0472, G0475, S3645), deletion of CPT 0500T (effective 1/1/2025), and a revised description for CPT 87624 effective 1/1/2025. Verify code-specific prior authorization and billing applicability before claim submission.

Billing Rule

Verify payer site for effective dates and PA implications of coding updates

Verify the payer's site for effective dates and any implications of coding changes (added/removed/revised CPT codes) prior to ordering or billing.

Revision history documents added and removed CPT codes and description revisions; verify effective dates and implications on billing (Chunk 128).