No prior authorization specified — coverage per clinical indications

This policy excerpt does not specify any prior authorization requirement for STI assays; coverage is determined by whether the requested test meets the clinical indications described in the policy (e.g., CC criteria).

No prior authorization stated for proprietary assays in excerpt

Proprietary assays (examples: BD Onclarity, Cepheid Xpert CT/NG, Abbott Alinity m STI) are described with their specimen/indication details, but the policy text in this excerpt does not state any payer prior authorization requirement for these assays.

• Use manufacturer/FDA indications and specimen guidance when ordering proprietary platform tests.
• No PA language for these assays appears in the provided sections.

No explicit prior authorization requirements stated

The document reiterates that no explicit prior authorization requirements are specified in the policy sections presented; ensure coding and specimen type match the test performed when submitting claims.

• Confirm specimen type per platform (urine, clinician- or patient-collected vaginal swab, endocervical swab, pharyngeal/rectal swabs).

M. genitalium testing — use FDA-cleared NAATs; resistance testing when available

For Mycoplasma genitalium, the policy aligns with CDC recommendations: use FDA-cleared NAATs for indicated specimen types and perform resistance testing when available to guide therapy.

• NAAT specimen types include urine and urethral, penile meatal, endocervical, and vaginal swabs.
• If resistance testing is available, perform it to inform treatment for recurrent or persistent infections.

No prior authorization noted in guideline excerpts

Guideline and coverage text describe laboratory testing as standard-of-care using NAATs/serology where appropriate; no prior authorization requirement is specified in the guideline excerpts included here.

• NAATs are described as standard-of-care for chlamydia/gonorrhea; serologic algorithms described for syphilis.

Proprietary assay coding — verify billing per listed proprietary codes

The policy lists specific proprietary panel/assay CPT/U codes in the coding section; payer verification may be needed to ensure correct billing when using these proprietary tests.

• Examples of proprietary codes listed include 0064U, 0065U, 0402U and others.
• Verify appropriate code mapping and payer requirements before claim submission.

Coding updates — verify PA requirements for added/removed CPT codes

Coding changes in the revision history (e.g., addition of CPT 87800 and other new/removed codes) mean providers should verify whether newly added or revised CPT codes require prior authorization under payer systems before submitting claims.

• Added codes referenced include 87800, 0483U, 0484U, and 87626; multiple older codes were removed.
• Confirm PA rules for any newly used CPT/HCPCS before ordering or billing.

Verify prior authorization requirements on new/updated CPT codes

Operational recommendation: when ordering tests that use newly added or updated CPT codes referenced by this policy, providers should confirm payer-specific prior authorization rules and billing mappings to avoid claim issues.

• Check payer portals or contact provider services for PA requirements on codes such as 87800, 0402U, 87563, and other recent additions.
• Ensure the claim's specimen and indication match the policy-covered clinical scenarios.

No step therapy described

No step therapy requirements are described in this policy excerpt for diagnostic STI testing.

Syphilis diagnostic algorithm described — no step therapy

The policy describes a syphilis diagnostic algorithm (two-tiered treponemal and non-treponemal testing) and does not impose step therapy for testing.

• Algorithms detail reflex testing (TT and NTT) rather than step-therapy requirements.

No step therapy requirements for STI diagnostic tests

The policy explicitly states there are no step therapy requirements for STI diagnostic tests in the provided sections.

Obtain gonorrhea culture for suspected treatment failure and susceptibility testing

When gonorrhea treatment failure or suspected resistance is encountered, the policy requires culture capacity for N. gonorrhoeae to perform antimicrobial susceptibility testing.

• Obtain gonococcal culture for antimicrobial susceptibility when individuals do not respond to initial treatment.
• CDC recommends labs maintain or partner for culture capacity for surveillance and susceptibility testing.

Provider actions not specified in this document

This document does not specify certain provider actions referenced in other policies; where requirements are not specified here, follow the clinical indications and code verification steps outlined in the policy and applicable government rules.

Document clinical justification: risk status, symptoms, age, sexual assault, HIV status, and timing

Document the clinical justification for covered testing: risk category or high-risk status, symptoms, patient age (e.g., <18), sexual assault follow-up, HIV status, and timing relative to prior infection or treatment (e.g., TOC intervals).

• Indicate symptomatic vs asymptomatic and whether patient meets Note 8 high-risk criteria when ordering T. vaginalis NAAT or other screening.
• For TOC or retesting, document timing (e.g., >=3 months for trichomoniasis, 3-month TOC for chlamydia in some indications).

No explicit documentation/submission requirements for proprietary tests in excerpt; follow assay guidance

No explicit documentation or submission instructions are provided for proprietary tests in these chunks; use assay-specific specimen and indication guidance described by manufacturers when ordering and documenting.

• Follow platform-specific specimen guidance (e.g., Cervical swab for BD Onclarity; urine or vaginal/endocervical swabs for Abbott Alinity and Cepheid Xpert).

Document specimen type and collection method on orders and claims

Document the specimen type and collection method (e.g., clinician-collected endocervical swab, patient-collected vaginal swab in clinic, first-catch urine, pharyngeal or rectal swab) to support use of platform-specific assays.

• Cepheid Xpert and Abbott Alinity list acceptable specimen types—confirm and document the specimen on the order and claim.
• Specimen source impacts test sensitivity and appropriateness (e.g., rectal pharyngeal sampling when exposure indicated).

Neurosyphilis signs — obtain and document CSF cell/protein and reactive CSF‑VDRL

For patients with signs suggesting neurosyphilis, document CSF evaluation including cell count/protein and a reactive CSF‑VDRL; ocular/neurologic findings should prompt CSF testing prior to treatment as described by CDC guidance.

• Document neurologic, ocular, or otologic symptoms and CSF results (cell count/protein and CSF‑VDRL) when pursuing neurosyphilis evaluation.

Syphilis testing documentation — algorithm, reflex quantitative NTT, repeat testing

Document which serologic algorithm was used for syphilis testing (treponemal vs non-treponemal approach), include reflex quantitative NTT results and note any planned repeat testing to support coverage determinations.

• If TT used as primary screen and positive, document reflex quantitative NTT titer (target >=1:8 to 1:16) performed on same serum.
• If discordant (TT positive/NTT negative) without suspicion of early syphilis, document plan to repeat both tests in 1 month.

Syphilis confirmatory testing — document alternate treponemal test and quantitative RPR/VDRL

When initial syphilis screening is positive, document confirmatory testing with an alternate treponemal test and a quantitative RPR or VDRL; include specimen sources and results for screening and confirmatory tests.

• Record both treponemal and nontreponemal test results; include titers for quantitative NTT (RPR/VDRL).
• If primary NTT was used, ensure a reflex TT is performed and documented.

Document indication for T. vaginalis NAAT per CC10 subcriteria

For qualitative NAAT for T. vaginalis, document the indication in line with CC10 subcriteria: symptomatic status, timing of follow-up testing (>=3 months), membership in a high-risk group per Note 8, HIV-positive status if applicable, or sexual assault follow-up.

• CC10 enumerates coverage scenarios (symptomatic; >=3 months follow-up; annual screening for high-risk or HIV-positive asymptomatic individuals; sexual assault follow-up).
• Ensure documentation references the specific CC10 subcriterion that justifies testing.

Support T. vaginalis NAAT coverage with documentation of status, timing, and risk

For coverage of T. vaginalis qualitative NAAT, ensure documentation supports symptomatic status, timing of follow-up testing (>=3 months), high-risk membership per Note 8, HIV status if relevant, or sexual assault follow-up as applicable.

• Retesting after initial diagnosis should be documented as occurring at least 3 months post-diagnosis when used as follow-up.
• For annual screening under CC10.c/d, document high-risk status or HIV-positive status per policy Note 8.

Denial risk — tests explicitly designated as not meeting coverage criteria

Tests explicitly listed as not meeting coverage criteria (e.g., PCR/NAAT for syphilis; serology for chlamydia/LGV; rapid enzyme immunoassays for Trichomonas; nucleic acid testing for antimicrobial susceptibility) may trigger claim denial if submitted for coverage.

• CC23: NAAT to determine antimicrobial susceptibility for N. gonorrhoeae or macrolide resistance in M. genitalium does not meet coverage criteria.
• CC24: Direct probe detection and/or quantitative NAAT for listed organisms does not meet coverage criteria.

No additional explicit denial-trigger actions in excerpt

There are no additional denial-trigger provider actions explicitly stated in this excerpt.

Use NAAT for chlamydia and gonorrhea per guideline recommendations — non-NAAT methods risk denial

When screening or diagnosing chlamydia and gonorrhea, use NAATs per USPSTF/CDC recommendations; ordering lower-sensitivity non-NAAT methods where NAAT is recommended may risk noncoverage or denial.

• USPSTF and CDC recommend NAAT for chlamydia and gonorrhea screening in indicated populations.
• Avoid antigen-based POCTs as primary screening due to low sensitivity compared to NAAT.

Do not use a single serologic test alone for syphilis — perform/ document both TT and NTT

Do not rely on a single serologic test (treponemal OR nontreponemal) alone for syphilis diagnosis; submitting only one test without appropriate reflex/confirmatory testing may leave workup incomplete and risk denial or inadequate documentation.

• Policy and CDC guidance require both treponemal and nontreponemal tests interpreted together for diagnosis.
• If TT is primary and positive, a reflex quantitative NTT should be performed and documented.

Syphilis reflex testing expectation — perform reflex quantitative NTT (target >=1:8–1:16)

Failure to perform the recommended reflex quantitative non-treponemal test (e.g., RPR/VDRL titration to at least 1:8–1:16) when a treponemal test is positive may result in incomplete confirmatory workup and potential coverage issues.

• Reflex quantitative NTT titration should reach at least 1:8 to 1:16 dilution per guidance.
• Document reflex testing and titer results on the medical record and claim as applicable.

Government policy precedence — follow LCD/NCD/Medicaid rules when applicable

If there is any conflict between this policy and applicable government coverage (LCDs/NCDs or state Medicaid), the government policy governs determinations; failure to follow an applicable government policy could affect coverage decisions.

Denial risk — direct probe detection / quantitative NAAT under CC24 not covered

Tests that fall under CC24 (direct probe detection and/or quantitative NAAT for specified microorganisms) are designated as NOT MEETING COVERAGE CRITERIA and therefore may be denied if billed under the indicated scenarios.

• CC24 lists organisms including C. trachomatis, N. gonorrhoeae, HSV-1/2, HPV, and T. pallidum.
• Do not submit direct probe detection or quantitative NAAT for coverage when CC24 applies.

Do not submit NAATs intended to determine antimicrobial susceptibility — CC23 not covered

Claims for NAAT performed to determine antimicrobial susceptibility in N. gonorrhoeae or macrolide resistance in M. genitalium are designated as not meeting coverage criteria (CC23) and are subject to denial.

• CC23 explicitly states nucleic acid testing for antimicrobial susceptibility in N. gonorrhoeae or macrolide resistance in M. genitalium does not meet coverage criteria.