CONCERT INFECTIOUS DISEASE: GENITOURINARY TESTING (vaginitis, vaginosis, UTI) - Coverage Criteria
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Outpatient testing policy for diagnostic laboratory evaluation of vaginitis/vaginosis and urinary tract infections, specifying medically necessary indications and investigational/unsupported tests for providers and payers.
Added numerous CPT codes to the coding table including expanded vaginal/urine and infectious agent detection codes (e.g., 87510, 87660, 87808, 87810, 87850, 0371U, 0372U, 0374U, 0504U, 81515, 87528-87539, 87901, 87903-87904, 87906).
Changed policy statements from 'may be considered medically necessary' to 'are considered medically necessary' for Targeted Vaginitis/Vaginosis Pathogen Testing and For Expanded Multiplex Vaginitis/Vaginosis Pathogen Panels.
Added specific laboratory tests (e.g., Urinary Tract Infection Testing and Vaginal Infection Testing by NxGen MDx, LLC) to the Policy Reference Table.
Removed several CPT/other codes from the policy reference table (examples: 87510 earlier corrected then later added; removed deleted code 0352U).
Coverage Criteria
Targeted Vaginitis/Vaginosis Pathogen Testing (Medically Necessary)
Covered when ALL of the following are met:
See investigational criteria for asymptomatic pregnancy
Symptom list taken verbatim from policy
Targeted Vaginitis/Vaginosis Pathogen Testing (Investigational)
Investigational (tests not covered) when ANY of the following apply:
Explicitly listed as investigational in policy
Expanded Multiplex Vaginitis/Vaginosis Pathogen Panels (Investigational)
Investigational when ANY of the following are true:
Expanded multiplex vaginitis/vaginosis panels (>6 targets) are considered investigational for all indications
Urine Culture for Asymptomatic Bacteriuria (Medically Necessary)
Considered medically necessary when ANY of the following are met:
Supported by IDSA guideline recommending screening in pregnancy
Procedure examples listed in policy definitions and supported by IDSA guidance
Urine Culture for Asymptomatic Bacteriuria (Investigational)
Considered investigational (not medically necessary) when ANY of the following apply:
Policy and IDSA guidance recommend against screening in most other populations
Molecular/Multiplex UTI Panels (Investigational)
Coverage stance:
No professional guidelines identified to support use
Medical necessity stance revisions
Policy-level wording changes implemented in the recent revision:
Expanded multiplex vaginitis/vaginosis pathogen panels that include more than 6 targets are designated investigational and are therefore excluded from coverage. Similarly, molecular/multiplex UTI panels are considered investigational for all indications and are excluded from coverage under this policy.
Operational maintenance of the coding table is performed as part of regular revisions; recent updates included adding numerous CPT and PLA codes and removing obsolete entries. Notably, the revision record documents that the deleted code 0352U was removed from the policy reference/coding table.
Targeted vaginitis/vaginosis pathogen testing performed for asymptomatic pregnant members/enrollees is considered investigational and therefore not medically necessary under this policy, regardless of preterm labor risk.
Revision notes indicate editorial updates to the policy’s medical necessity language: select sections were changed from phrasing that tests "may be considered medically necessary" to definitive language that they "are considered medically necessary." These wording adjustments are reflected in the policy history and coding implications sections.
Coding and Billing
| 0321U | Infectious agent detection by nucleic acid (DNA or RNA), genitourinary pathogens, identification of 20 bacterial and fungal organisms and identification of 16 associated antibiotic-resistance genes, multiplex amplified probe technique. |
| 0330U | Infectious agent detection by nucleic acid (DNA or RNA), vaginal pathogen panel, identification of 27 organisms, amplified probe technique, vaginal swab. |
| 0371U | Infectious agent detection by nucleic acid (DNA or RNA), genitourinary pathogen, semiquantitative identification, DNA from 16 bacterial organisms and 1 fungal organism, multiplex amplified probe technique via quantitative polymerase chain reaction (qPCR), urine. |
| 0372U | Infectious disease (genitourinary pathogens), antibiotic-resistance gene detection, multiplex amplified probe technique, urine, reported as an antimicrobial stewardship risk score. |
| 0374U | Infectious agent detection by nucleic acid (DNA or RNA), genitourinary pathogens, identification of 21 bacterial and fungal organisms and identification of 21 associated antibiotic-resistance genes, multiplex amplified probe technique, urine. |
| 0504U | Infectious disease (urinary tract infection), identification of 17 pathologic organisms, urine, real-time PCR, reported as positive or negative for each organism. |
| 81513 | Infectious disease, bacterial vaginosis, quantitative real-time amplification of RNA markers for Atopobium vaginae, Gardnerella vaginalis, and Lactobacillus species, utilizing vaginal-fluid specimens, algorithm reported as a positive or negative result for bacterial vaginosis. |
| 81514 | Infectious disease, bacterial vaginosis and vaginitis, quantitative real-time amplification of DNA markers for Gardnerella vaginalis, Atopobium vaginae, Megasphaera type 1, BVAB-2, and Lactobacillus species; includes separate detection of Trichomonas vaginalis and/or Candida species. |
| 81515 | Infectious disease, bacterial vaginosis and vaginitis, real-time PCR amplification of DNA markers for Atopobium vaginae, Atopobium species, Megasphaera type 1, BVAB-2; includes separate detection of Trichomonas vaginalis and Candida species, with Candida glabrata/Candida krusei when reported. |
| 87086 | Culture, bacterial; quantitative colony count, urine. |
| 87088 | Culture, bacterial; with isolation and presumptive identification of each isolate, urine. |
| 87481 | Infectious agent detection by nucleic acid (DNA or RNA); Candida species, amplified probe technique. |
| 87482 | Infectious agent detection by nucleic acid (DNA or RNA); Candida species, quantification. |
| 87490 | Infectious agent detection by nucleic acid (DNA or RNA); Chlamydia trachomatis, amplified probe technique. |
| 87491 | Infectious agent detection by nucleic acid (DNA or RNA); Chlamydia trachomatis, amplified probe technique. |
| 87492 | Infectious agent detection by nucleic acid (DNA or RNA); Chlamydia trachomatis, quantification. |
| 81513 | Infectious disease, bacterial vaginosis, quantitative real-time amplification of RNA markers for Atopobium vaginae, Gardnerella vaginalis, and Lactobacillus species; algorithm reported as positive/negative for bacterial vaginosis |
| 81514 | Infectious disease, bacterial vaginosis and vaginitis, quantitative real-time amplification of DNA markers for Gardnerella vaginalis, Atopobium vaginae, Megasphaera type 1, BVAB-2, and Lactobacillus species; includes separate detection of Trichomonas vaginalis and/or Candida species |
| 81515 | Infectious disease, bacterial vaginosis and vaginitis, real-time PCR amplification of DNA markers for Atopobium vaginae, Atopobium species, Megasphaera type 1, BVAB-2; includes separate detection of Trichomonas vaginalis and Candida species, Candida glabrata/Candida krusei when reported |
| 87086 | Culture, bacterial; quantitative colony count, urine |
| 87088 | Culture, bacterial; with isolation and presumptive identification of each isolate, urine |
| 87481 | Infectious agent detection by nucleic acid; Candida species, amplified probe technique |
| 87482 | Infectious agent detection by nucleic acid; Candida species, quantification |
| 87490 | Infectious agent detection by nucleic acid; Chlamydia trachomatis, amplified probe technique |
| 87491 | Infectious agent detection by nucleic acid; Chlamydia trachomatis, amplified probe technique |
| 87492 | Infectious agent detection by nucleic acid; Chlamydia trachomatis, quantification |
| 87498 | Infectious agent detection by nucleic acid; enterovirus, amplified probe technique |
| 87500 | Infectious agent detection by nucleic acid; vancomycin resistance (eg, enterococcus van A, van B), amplified probe technique |
| 87510 | Infectious agent detection by nucleic acid; Gardnerella vaginalis, direct probe technique |
| 87511 | Infectious agent detection by nucleic acid; Gardnerella vaginalis, amplified probe technique |
| 87512 | Infectious agent detection by nucleic acid; Gardnerella vaginalis, quantification |
| 87528 | Infectious agent detection by nucleic acid; Herpes simplex virus, direct probe technique |
| 87529 | Infectious agent detection by nucleic acid; Herpes simplex virus, amplified probe technique |
| 87530 | Infectious agent detection by nucleic acid; Herpes simplex virus, quantification |
| 87531 | Infectious agent detection by nucleic acid; Herpes virus-6, direct probe technique |
| 87532 | Infectious agent detection by nucleic acid; Herpes virus-6, amplified probe technique |
| 87533 | Infectious agent detection by nucleic acid; Herpes virus-6, quantification |
| 87534 | Infectious agent detection by nucleic acid; HIV-1, direct probe technique |
| 87535 | Infectious agent detection by nucleic acid; HIV-1, amplified probe technique, includes reverse transcription |
| 87536 | Infectious agent detection by nucleic acid; HIV-1, quantification, includes reverse transcription |
| 87537 | Infectious agent detection by nucleic acid; HIV-2, direct probe technique |
The most recent revision included code-list maintenance and adjustments to the coding implications section. Several CPT/PLA codes were added to the coding table and obsolete or deleted codes were removed as part of this update; these operational edits are documented in the policy revision history.
Provider Actions and Documentation Requirements
Prior Authorization — Confirm Requirements
Prior authorization governance: Providers should confirm whether prior authorization (PA) is required for specific high-complexity or multiplex tests prior to ordering. Coverage determinations in this policy may interface with PA processes; PA requirements and submission instructions are governed by the member's specific plan and Health Plan administrative procedures.
- Confirm PA requirements for high-complexity or multiplex molecular panels (including tests identified by proprietary or U-codes).
- Submit clinical justification and required documentation with any PA request per Health Plan instructions.
Investigational Tests — Denial Risk
Investigational tests may trigger denial: Expanded multiplex panels (>6 targets), molecular/multiplex UTI panels, and other tests designated investigational in this policy are subject to denial when submitted for indications not supported by the policy.
- Expanded multiplex vaginitis/vaginosis panels with more than six targets (investigational).
- Molecular/multiplex UTI panels (investigational).
- Other targeted tests flagged investigational in the coding/coverage sections (see policy coding implications).
Urine Culture for ASB — Denial Risk
Urine culture for asymptomatic bacteriuria (ASB): Ordering urine cultures for ASB outside of the medically necessary indications listed in this policy may be denied.
- Urine culture for ASB is considered medically necessary only for pregnant members or members undergoing endoscopic urologic procedures with mucosal trauma.
- Urine cultures for ASB outside these indications are investigational and may be denied.
Documentation and Coverage Governance
Documentation and coverage governance: Providers must follow the coverage terms in the member's benefit plan and retain clinical documentation supporting medical necessity per contract and regulatory requirements.
- Maintain and provide, upon request, clinical records that demonstrate the symptomatic findings, indications, and rationale for testing.
- Coverage decisions are subject to plan terms, exclusions, state and federal requirements, and Health Plan administrative policies.
Required Clinical Documentation
Required clinical documentation: To support testing for vaginitis/vaginosis or urine culture, document the presence of relevant symptoms and findings.
- For vaginitis/vaginosis testing: abnormal vaginal discharge, vulvovaginal itching/irritation/redness, dyspareunia, dysuria, or postcoital/contact bleeding.
- For urine culture (ASB) testing: pregnancy status or planned endoscopic urologic procedure with mucosal trauma.
- Include pertinent exam findings, symptom onset/duration, and any prior test results or prior treatments tried.
Coverage Administrative Constraints
Coverage administrative constraints: Coverage is subject to member-specific benefit terms and may vary by contract; the Health Plan may change or withdraw this policy and apply additional administrative rules.
- Verify member eligibility and benefits prior to ordering.
- Policy effective/posting dates and any regulatory requirements govern applicability; when discrepancies exist, law/regulation prevails.
Background
Urinary tract infections (UTIs) can involve the lower or upper urinary tract and commonly arise from bacterial colonization or instrumentation. Symptoms range from dysuria and frequency to flank pain and systemic signs in upper tract infection. Vaginitis and vaginosis encompass multiple etiologies — including bacterial vaginosis, Candida species (yeast), and Trichomonas vaginalis — and present with overlapping symptoms such as abnormal vaginal discharge, vulvovaginal itching, irritation, or painful intercourse. Because symptoms cannot reliably distinguish cause, targeted diagnostic testing (culture, microscopy, NAAT/PCR, or limited multipathogen panels) is used in the outpatient setting to identify the responsible organism(s) and guide appropriate therapy.
Definitions and Examples
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