Capital Bluecross Vaginitis Diagnosis Coverage

Coverage Summary

This policy (AHS M2057, effective 2015-09-18, status CURRENT) addresses diagnosis of vaginitis, specifically the three primary conditions: bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), and trichomoniasis (TV)

The policy outlines coverage and diagnostic approaches including traditional in-office tests (Amsel criteria, Nugent Gram stain, wet mount, culture) and molecular methods. It recognizes FDA-cleared multiplex NAAT panels (eg, BD MAX Vaginal Panel, Aptima BV and CV/TV assays) and lists related CPT/CPT‑like codes, stating a mixed coverage stance: multiplex NAATs and organism-specific NAATs MEET coverage criteria for symptomatic individuals while screening asymptomatic persons is not supported.

High-level guidance emphasizes that multiplex NAATs are intended for symptomatic patients, provide higher sensitivity and NPV than clinician assessment or some POCTs, detect coinfections, and are not intended for routine screening, prognostic use, or test-of-cure.

Key facts and thresholds

Primary conditions addressed3 (BV, VVC, Trichomoniasis)

FDA-cleared multiplex NAATs referencedmultiple (eg, BD MAX Vaginal Panel; Aptima BV and CVITV)

CPT/HCPCS codes providedlisted (examples: 0330U, 0505U, 81513, 81514, 81515, 87480-87482, 87511-87512, 87660-87661, Q0111)

Vaginal pH threshold for BV> 4.5

Amsel criteria threshold3 of 4 findings

Intended use of multiplex NAATsFor symptomatic patients; not intended for routine screening or test-of-cure

Diagnostic Testing Criteria

Relevant Codes (CPT / HCPCS / Proprietary)

Molecular NAAT / Proprietary Vaginal Panel Codes (listed by FDA/test descriptions)CPT

0330U	Infectious agent detection by nucleic acid (DNA or RNA); vaginal pathogen panel, identification of 27 organisms, amplified probe technique, vaginal swab (Bridge Women's Health Infectious Disease Detection Test)
0505U	Infectious disease (vaginal infection), identification of 32 pathogenic organisms, swab, real-time PCR, reported as positive or negative for each organism (NxGen MDx LLC Vaginal Infection Testing)
Q0111	Wet mounts including preparations of vaginal/cervical or skin specimens

Aptima BV / CV/TV / BD MAX / Proprietary NAATs (FDA cleared)mixed

81513	Aptima BV Assay: quantitative real-time amplification of RNA markers for Atopobium vaginae, Gardnerella vaginalis, and Lactobacillus species, reported as positive/negative for BV (Hologic)
81514	Infectious disease, BV 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 and/or Candida species; used in conjunction with 87480-87661 range
81515	BD MAX Vaginal Panel: infectious disease, BV and vaginitis, real-time PCR amplification (Becton Dickinson)

Individual organism NAAT / molecular CPT codesCPT

87480	Infectious agent detection by nucleic acid (DNA or RNA); Candida species, direct probe technique
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
87511	Infectious agent detection by nucleic acid (DNA or RNA); Gardnerella vaginalis, amplified probe technique
87512	Infectious agent detection by nucleic acid (DNA or RNA); Gardnerella vaginalis, quantification
87660	Infectious agent detection by nucleic acid (DNA or RNA); Trichomonas vaginalis, direct probe technique
87661	Infectious agent detection by nucleic acid (DNA or RNA); Trichomonas vaginalis, amplified probe technique
87797	Infectious agent detection by nucleic acid (DNA or RNA), not otherwise specified; direct probe technique; each organism
87798	Infectious agent detection by nucleic acid (DNA or RNA), not otherwise specified; amplified probe technique; each organism
87799	Infectious agent detection by nucleic acid (DNA or RNA); not otherwise specified; quantification; each organism

Ancillary / non-NAAT lab and POCT codesmixed

82120	Amines, vaginal fluid, qualitative (whiff test)
83986	pH; body fluid, not otherwise specified
87070	Culture, bacterial; any other source except urine, blood or stool, aerobic, with isolation and presumptive identification of isolates
87149	Culture, typing; identification by nucleic acid (DNA or RNA) probe, direct probe technique, per culture or isolate, each organism probed
87150	Culture, typing; identification by nucleic acid (DNA or RNA) probe, amplified probe technique
87480	Also listed under molecular: wet mount / infectious agent detection references
87808	Infectious antigen detection by immunoassay with direct optical observation; Trichomonas vaginalis antigen
87905	Infectious agent enzymatic activity other than virus (eg, sialidase activity in vaginal fluid)

Required Actions & Billing Notes

Documentation Required
Symptom documentation and initial diagnostic workup
For symptomatic patients, document a complete history and physical exam and perform vaginal pH testing, a potassium hydroxide (KOH) whiff test, and microscopy (wet mount) of vaginal discharge as the initial evaluation per guideline recommendations.

Prior Authorization
Use of multiplex NAATs limited to symptomatic patients
Multiplex NAAT assays are intended for use in symptomatic patients with signs consistent with vaginitis/vaginosis and are not intended for routine screening of asymptomatic patients, prognostic use, or as a test-of-cure. Prior authorization applies to these proprietary/multiplex NAAT codes when used outside intended symptomatic indications.
0330U
0505U
81513
81514

Background & Evidence

This section compiles guideline recommendations from major organizations (ACOG, IDSA, SOGC, Australian guidelines, CDC and USPSTF) that support a standard initial evaluation of symptomatic vaginitis using history, physical exam, vaginal pH, KOH whiff test, and microscopy; and that recommend specific tests: Amsel or Nugent Gram stain for BV, microscopy/culture for VVC confirmation, and NAAT for trichomoniasis.

The background summarizes regulatory and test-specific information: multiple FDA-cleared multiplex NAATs (eg, BD MAX Vaginal Panel; Aptima BV and Aptima CV/TV) and several laboratory-developed multiplex assays exist. Evidence and guideline statements note that NAATs have higher sensitivity and negative predictive value than clinician assessment or many point-of-care tests and can identify mixed infections, but their diagnostic accuracy is established primarily for symptomatic women and may detect organisms of uncertain clinical relevance in asymptomatic persons.

Label	Value
ACOG Practice Bulletin Number 215
2020 (reaffirmed 2022) — Recommends Amsel criteria or Gram stain with Nugent scoring for BV; NAAT for trichomoniasis; microscopy or culture or commercial diagnostic test positive for Candida species to confirm VVC; notes advanced single‑swab multiplex PCR/DNA probe panels as a promising alternative to microscopy
IDSA guidance
Supports diagnostic confirmation prior to empiric antifungal therapy; describes FDA‑cleared multiplex vaginal NAATs (BD MAX, Aptima BV/CV/TV, Xpert/Cepheid) and notes multiplex NAATs have higher sensitivity and NPV than clinician assessment or POCTs and detect coinfections; multiplex tests intended for symptomatic patients and not for screening asymptomatic patients or test‑of‑cure
FDA approvals
BD MAX Vaginal Panel: Class III designation (approved 2016; modification 2019); Aptima BV Assay: FDA approved May 23, 2019; Aptima CV/TV and other Aptima assays FDA cleared in 2019; code descriptors and proprietary panel codes listed (e.g., 81513, 81514, 81515, 0330U, 0505U)

Definitions

Amsel criteriaClinical diagnosis requiring 3 of 4 findings: thin homogenous discharge; pH >4.5; positive whiff test; clue cells on microscopy

Nugent scoreGram stain scoring method for BV based on bacterial morphotypes (laboratory reference standard)

NAATNucleic acid amplification test — molecular methods for pathogen detection (eg, PCR, TMA)

OpenPayer

Diagnosis of Vaginitis

Coverage Summary

Diagnostic Testing Criteria

Relevant Codes (CPT / HCPCS / Proprietary)

Required Actions & Billing Notes

Background & Evidence

Revision History