CurrentFidelis CarePolicy FC.CG.PP.07

Payment Policy: Infectious Disease Genitourinary Testing

Defines coverage and reimbursement rules for outpatient genitourinary infectious disease testing (vaginitis/vaginosis and urinary tract infections) for Fidelis Care members on Medicaid and the Health Insurance Marketplace.

Policy Summary

PayerFidelis Care

PolicyInfectious Disease Genitourinary Testing

Policy CodePolicy FC.CG.PP.07

Change TypeNo material change

Effective Date

Next Review Date

Key ActionOrder targeted vaginitis/vaginosis testing only when clinical criteria are met; targeted panels must be six targets or fewer.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≤6 targetsAllowed vaginitis/vaginosis panels size

>6 targetsNot covered

Not coveredMolecular/multiplex UTI panels

Pregnancy or procedureUrine culture for asymptomatic bacteriuria

Medicaid & MarketplaceApplies to

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Coverage Criteria for Genitourinary Infectious Disease Testing

Targeted vaginitis/vaginosis testing criteria

Covered when ALL of the following are met:

ALL of the following

Test modality
- Test modality: direct probe for Gardnerella vaginalis, Candida albicans, and/or Trichomonas vaginalis.
- Nucleic acid/PCR tests for bacterial vaginosis, candidiasis, and/or trichomoniasis.
- Multipathogen panel of six targets or fewer (with or without chlamydia and/or gonorrhea).
Clinical indication
- Abnormal vaginal discharge.
- At least one of: vulvovaginal itching/irritation/redness (e.g., pruritus, erythema, edema); painful urination (dysuria); painful sexual intercourse (dyspareunia); or postcoital/contact bleeding.
Also covered for asymptomatic pregnant members/enrollees (regardless of preterm labor risk).

Limitations on targeted testing

Not covered when the following applies:

Targeted vaginitis/vaginosis pathogen testing (direct probe, nucleic acid/PCR, or multipathogen panel ≤6 targets) is not covered for indications other than those specified above (i.e., not covered for all other indications).

Expanded multiplex vaginitis/vaginosis panels

Expanded multiplex panels are excluded as follows:

Expanded multiplex vaginitis/vaginosis pathogen panels with more than six targets are not covered.

Urine culture coverage

Urine culture for asymptomatic bacteriuria is covered ONLY when at least one of the following applies:

ANY of the following

Member/enrollee is pregnant.
Member/enrollee will undergo an endoscopic urologic procedure with mucosal trauma.

Urine culture for asymptomatic bacteriuria is not covered for all other indications.

Molecular/multiplex UTI panels

Exclusion (no covered indications):

Molecular/multiplex UTI panels are not covered for all indications.

Coverage and administrative rules

Administrative and legal constraints that affect coverage determinations:

This payment policy is a guide; coverage and payment determinations are subject to all terms, conditions, exclusions and limitations of the member's coverage documents and to applicable state and federal requirements.

For Medicaid members, state Medicaid provisions take precedence if they conflict with this payment policy; for Medicare members, applicable NCDs and LCDs should be reviewed prior to applying these criteria.

Fidelis Care may change, amend, or withdraw this payment policy at any time; the policy does not constitute medical advice or a guarantee of payment. Providers are expected to exercise professional medical judgment and remain independent contractors.

Specific CPT and assay codes for nucleic acid and antigen testing are enumerated in the policy for billing reference.

Codes and Billing

Referenced CPT / Procedure CodesCPT

0321U	Infectious agent detection by nucleic acid (DNA or RNA) genitourinary pathogens, identification of 20 bacterial and fungal organisms and 16 antibiotic-resistance genes, multiplex amplified probe technique.
0330U	Infectious agent detection by nucleic acid; vaginal pathogen panel, identification of 27 organisms, amplified probe technique (vaginal swab).
0371U	Infectious agent detection by nucleic acid, genitourinary pathogen, semiquantitative identification of 16 bacterial and 1 fungal organism, multiplex amplified probe technique via 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, genitourinary pathogens, identification of 21 bacterial and fungal organisms and 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; algorithm reported as positive/negative for BV.
81514	Infectious disease, bacterial vaginosis and vaginitis, quantitative real-time amplification of DNA markers for multiple organisms, 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 and BV-associated bacteria, includes separate detection of Trichomonas vaginalis and Candida species.
87086	Culture, bacterial; quantitative colony count; urine.

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Provider Actions, Billing Guidance, and Exceptions

Documentation Required

General administrative guidance

It is the policy of Fidelis Care that the specific tests noted below are covered when meeting the clinical requirements described in the policy. Providers must follow applicable plan coverage rules, documentation requirements, and state/federal regulations when ordering and billing for infectious disease/genitourinary testing. Payment is subject to the member's benefit plan terms, exclusions, limitations, and Fidelis Care administrative policies. The effective date posted may not be the same as the policy effective date; providers should verify the operative effective date before rendering services.

Coverage and payment determinations are governed by the member's evidence of coverage, certificate of coverage, policy, or contract.
Providers must exercise professional judgment; medical necessity documentation should be maintained in the medical record and made available on request.
Billing and coding must reflect the services rendered and adhere to applicable CPT/HCPCS/ICD-10 coding guidance and payer billing rules.
This payment policy is a guide to payment and does not guarantee reimbursement; payment is subject to plan terms and any applicable state or federal requirements.

Definitions and Terms

Endoscopic urologic procedure with mucosal trauma — examples

Examples of procedures with mucosal traumaTransurethral surgery of the prostate or bladder (e.g., TURP/TURBT).

Ureteroscopy including lithotripsyUreteroscopy procedures that include stone fragmentation (lithotripsy).

Percutaneous stone surgeryPercutaneous nephrolithotomy or other percutaneous approaches for stone removal.

Health Plan (definition and policy context)

Definition of Health Plan'Health Plan' means a health plan that has adopted this payment policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC, or an affiliate.

Policy purposeThis payment policy is a guide to payment and assists in coverage and payment determinations; it is not a contract or guarantee of payment.