Testing for Select Genitourinary Conditions
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Defines medical necessity and coding guidance for diagnostic evaluation of vaginitis and use of DNA/probe and amplified molecular tests in members aged ≥13; applies to providers and claims for Arizona Complete Health (Centene-affiliated) plans.
No material clinical or coverage changes in this revision.
Coverage Criteria — Diagnostic Testing for Vaginitis
Medically necessary diagnostic tests for symptomatic vaginitis
Covered when ALL of the following are met
Refer to Table 1 for covered CPT codes (e.g., 82120, 87480, 87510, 87905).
BV screening in asymptomatic pregnant women
Not medically necessary for screening
Rationale: no evidence that treatment of BV in asymptomatic pregnant women reduces these complications.
Not medically necessary: amplified/multiplex molecular testing
Not medically necessary — amplified/multiplex testing
Has not been shown to improve clinical outcomes over direct DNA-probe testing.
Not shown to improve clinical outcomes over direct DNA-probe testing.
Although multiplex PCR may have comparable diagnostic sensitivity/specificity to conventional criteria, evidence of clinical utility over direct testing is lacking.
Not Medically Necessary CPT/ICD Combinations
Certain CPT codes are considered not medically necessary when billed with specific ICD-10-CM diagnosis codes listed in the policy tables.
See Tables 4–7 for the enumerated CPT codes and corresponding ICD-10-CM diagnosis lists that define not medically necessary combinations.
This policy excludes the routine use of multiplex/multitarget PCR panel testing and amplified probe techniques for evaluation of vaginitis and certain gynecologic/obstetric indications. The policy states that current literature does not support multiplex/multitarget PCR panel testing of genitourinary pathogens commonly associated with vaginitis, and that unspecified amplified DNA-probe testing is considered not medically necessary for many diagnostic and screening uses because it has not been shown to improve clinical outcomes over direct DNA-probe testing. Specific examples of excluded amplified/multiplex assays include CPT codes such as 81513, 81514, 87511, and 87798, which are categorized as not medically necessary in the policy tables.
The policy documentation and revision history clarify that this policy does not apply to the diagnosis of Trichomonas vaginalis, nor does it address point-of-care tests such as vaginal pH testing or wet mount microscopic examinations. These items were specifically noted in the policy revision log as out of scope for the amplified/multiplex testing exclusions.
Unspecified amplified DNA-probe tests and certain multiplex/amplified CPT-coded assays are considered not medically necessary under this policy. The policy expressly lists amplified or multiplex assays—examples include CPT 81513 and 81514 (multiplex PCR panels) and CPT 87511 (Gardnerella vaginalis, amplified probe technique)—and also identifies CPT 87798 (amplified probe, not otherwise specified) as not medically necessary when used for the covered indications described in the policy.
The policy includes specific coding restrictions: CPT 87798 and CPT 87481 are designated as not medically necessary when billed with certain ICD-10-CM diagnosis codes listed in the policy tables. Table 4 lists CPT 87798 as a not medically necessary code, with Table 5 enumerating the ICD-10-CM diagnoses (for example, N76.0 Acute vaginitis; N76.2 Acute vulvitis; N39.0 Urinary tract infection). Table 6 identifies CPT 87481 as not medically necessary when billed with the diagnosis codes listed in Table 7 (the policy provides the full code pairings in those tables).
Coding — CPT and ICD-10 Guidance
| 82120 | Amines, vaginal fluid, qualitative |
| 87480 | Infectious agent detection by nucleic acid (DNA or RNA); Candida species, direct probe technique |
| 87510 | Infectious agent detection by nucleic acid (DNA or RNA); Gardnerella vaginalis, direct probe technique |
| 87905 | Infectious agent enzymatic activity other than virus (eg, sialidase activity in vaginal fluid) |
| 81513 | Infectious disease, bacterial vaginosis, quantitative real-time amplification of RNA markers (Atopobium vaginae, Gardnerella vaginalis, Lactobacillus spp.) |
| 81514 | Infectious disease, bacterial vaginosis and vaginitis, quantitative real-time amplification of DNA markers (Gardnerella, Atopobium, Megasphaera type 1, BVAB-2, Lactobacillus spp.; may include Trichomonas and Candida species) |
| 87511 | Infectious agent detection by nucleic acid (DNA or RNA); Gardnerella vaginalis, amplified probe technique |
| 87798 | Infectious agent detection by nucleic acid (DNA or RNA), not otherwise specified; amplified probe technique, each organism |
| B37.3 | Candidiasis of vulva and vagina |
| L29.2 | Pruritus of genitals |
| L29.3 | Pruritus of genitals |
| N76.0 | Acute vaginitis |
| N76.1 | Subacute and chronic vaginitis |
| N76.2 | Acute vulvitis |
| N76.3 | Subacute and chronic vulvitis |
| N77.1 | Vaginitis, vulvitis, and vulvovaginitis in diseases classified elsewhere |
| N89.8 | Other specific noninflammatory disorders of vagina |
| O23.511 | Infection of genitourinary tract in pregnancy |
| N39.0 | Urinary tract infection, site not specified |
| N72 | Inflammatory disease of cervix uteri |
| N76.0 | Acute vaginitis |
| N76.2 | Acute vulvitis |
| N89.9 | Noninflammatory disorder of vagina, unspecified |
| N90.89 | Other specified noninflammatory disorders of vulva and perineum |
| N90.9 | Noninflammatory disorder of vulva and perineum, unspecified |
| N91.0 | Absent menstruation |
| N91.1 | Oligomenorrhea |
| N91.2 | Hypomenorrhea |
| 87798 | Infectious agent detection by nucleic acid (DNA or RNA), not otherwise specified; amplified probe technique, each organism |
| 87481 | Infectious agent detection by nucleic acid (DNA or RNA); Candida species, amplified probe technique |
| B37.3 | Candidiasis of vulva and vagina |
| L29.2 | Pruritus of genitals |
| L29.3 | Pruritus of genitals |
| N39.0 | Urinary tract infection, site not specified |
| N72 | Inflammatory disease of cervix uteri |
| N76.0 | Acute vaginitis |
| N76.1 | Subacute and chronic vaginitis |
| N76.2 | Acute vulvitis |
| N76.3 | Subacute and chronic vulvovaginitis |
| N76.81 | Mucositis (ulcerative) of vagina and vulva |
Provider Actions — Billing, Documentation, and Prior Authorization
Not Medically Necessary CPT Codes — Denial Risk
Claims for the amplified/multiplex panel and amplified probe CPT codes listed below are considered not medically necessary and are at risk for denial when billed without meeting the policy's medical necessity criteria. Ensure documentation supports the clinical indication and that billed CPT/ICD-10-CM combinations are appropriate per policy tables. Prior authorization requirements (if any) should be verified separately with the payer prior authorization policy.
- Not medically necessary CPT codes — denial risk: 81513, 81514, 87511, 87798, 87481
- Not medically necessary code pairings: CPT 87798 billed with ICD-10-CM codes listed in Table 5 (e.g., N39.0, N72, N76.0, N76.2, N89.9, N90.89, N91.x–N94.x, etc.) are considered not medically necessary.
- Not medically necessary code pairings: CPT 87481 billed with ICD-10-CM codes listed in Table 7 (e.g., B37.3, L29.2, N39.0, N72, N76.0–N76.3, N89.8–N90.9, N91.x–N94.x, etc.) are considered not medically necessary.
- Support clinical indication: Documentation in the medical record must justify that the specific CPT code billed is appropriate for the member's clinical presentation; absence of supporting documentation may result in denial.
- Provider actions: Review Table 1 and Table 2 for CPT codes that are medically necessary when billed with supporting ICD-10-CM diagnosis codes; avoid billing amplified/multiplex panel codes when direct DNA-probe testing codes are indicated.
Provider Actions — Documentation and CPT/ICD Linkage
When billing CPT codes in Table 1, include a supporting ICD-10-CM diagnosis from Table 2 that justifies medical necessity. Claims with CPT codes listed as not medically necessary or with disallowed CPT/ICD pairings per policy tables may be denied. Check the payer prior authorization policy for any separate authorization requirements for molecular testing panels.
- Diagnostic ICD-10 linkage: Use ICD-10-CM codes from Table 2 to support medical necessity for CPT codes in Table 1 (e.g., B37.3, N76.x, O23.511-O23.93, Z72.51-Z72.53, etc.).
- Amplified/multiplex panel codes not supported: CPT 81513 and 81514 (multiplex PCR panel codes) are categorized as not medically necessary per Table 3.
- Amplified probe technique codes not supported: CPT 87511 and 87481 are restricted per Tables 3 and 6/7; verify diagnosis pairing before billing.
- CPT 87798 use restriction: CPT 87798 is considered not medically necessary when billed with the ICD-10-CM codes listed in Table 5.
Background
Vaginitis is most commonly caused by three etiologies: bacterial vaginosis (BV), trichomoniasis, and vulvovaginal candidiasis (VVC). Typical point-of-care diagnostic approaches include the KOH 'whiff' (amine) test, assessment of vaginal fluid pH, and microscopic examination of saline or KOH wet mounts to identify clue cells, yeast, or motile trichomonads. The policy specifies that for symptomatic women age ≥ 13, medically necessary diagnostic options include the KOH whiff test, an assay for sialidase activity, or direct DNA probe tests for Candida and Gardnerella vaginalis; multiplex PCR panels and unspecified amplified probe techniques are not supported as superior to these direct or point-of-care methods.
Definitions and Diagnostic Thresholds
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