CurrentBlue Cross Blue Shield - MassachusettsPolicy 711

Multitarget PCR testing for diagnosis of bacterial vaginosis — Coverage Criteria

This policy governs coverage and prior‑authorization requirements for multitarget polymerase chain reaction (PCR) tests to diagnose bacterial vaginosis (BV) for Blue Cross Blue Shield Massachusetts members, specifying clinical scenarios where testing is medically necessary versus investigational.

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyMultitarget PCR testing for diagnosis of bacterial vaginosis — Coverage Criteria

Policy CodePolicy 711

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain testing only for symptomatic individuals using FDA‑approved assays collected by the prescribing provider as an alternative to Amsel criteria or Gram stain with Nugent scoring.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3Covered CPT codes listed

3Investigational CPT codes listed

84-95% / 85-97%Reported sensitivity/specificity

BD Max, AptimaFDA-cleared test examples

~28

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Coverage Criteria for Multitarget PCR Testing for Bacterial Vaginosis

Medically necessary indications

Covered when ALL of the following are met

Clinical indication and test characteristics: Test is used as an alternative to Amsel clinical criteria or gram stain with Nugent scoring

From policy: alternative to Amsel or Nugent

Symptomatic: Individual must be symptomatic

Policy specifies symptomatic individuals

Assay approval: Assay must be FDA-approved

Policy requires FDA-approved assays

Specimen collection: Specimen must be collected by the prescribing provider

Policy requires provider-collected specimens

Investigational/Not covered

Not covered (investigational) when ANY of the following apply

Investigational uses: Multitarget PCR testing for diagnosis of bacterial vaginosis is considered investigational in all other scenarios not meeting the above criteria

Policy statement

The policy specifies that multitarget PCR testing for bacterial vaginosis is considered investigational when used in any scenario that does not meet the listed medically necessary conditions. In particular, testing is investigational if it is not being used as an alternative to Amsel clinical criteria or gram stain with Nugent scoring, if the individual is not symptomatic, if the assay is not FDA‑approved, or if the specimen was not collected by the prescribing provider. Tests used outside these conditions are therefore subject to denial as investigational.

The policy references the U.S. Preventive Services Task Force guidance that recommends against screening for bacterial vaginosis in pregnancy to prevent preterm delivery. Screening pregnant individuals for BV for the purpose of preventing preterm birth is therefore not supported by USPSTF guidance and would not be considered an appropriate indication under this policy.

Specific multitarget or multipathogen panels are listed as investigational for Commercial Members. Examples cited in the policy include CPT codes 0330U, 0505U, and 0557U, which describe broad vaginal pathogen panels and large multiplex organism lists; these tests are categorized as not covered under this policy for commercial members.

Relevant Billing and Diagnosis Codes

Covered CPT CodesCPTCovered

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, Bacterial Vaginosis Associated Bacteria-2 (BVAB-2), and Lactobacillus species, utilizing vaginal-fluid specimens, algorithm reported as a positive or negative for high likelihood of bacterial vaginosis, includes separate detection of Trichomonas vaginalis and/or Candida species when reported
81515	Infectious disease, bacterial vaginosis and vaginitis, real-time PCR amplification of DNA markers for Atopobium vaginae, Atopobium species, Megasphaera type 1, and Bacterial Vaginosis Associated Bacteria-2 (BVAB-2), utilizing vaginal-fluid specimens, algorithm reported as positive or negative for high likelihood of bacterial vaginosis, includes separate detection of Trichomonas vaginalis and Candida species when reported

Investigational CPT CodesCPTNot Covered

0330U	Infectious agent detection by nucleic acid (DNA or RNA), vaginal pathogen panel, identification of 27 organisms—amplified probe technique—vaginal swab
0505U	Infectious disease (vaginal infection), identification of 32 pathogenic organisms
0557U	Infectious disease, bacterial vaginosis and vaginitis, real-time amplification of DNA markers for Atopobium vaginae, Gardnerella vaginalis, Megasphaera types and 2, bacterial vaginosis associated bacteria-2 and -3 (BVAB-2, BVAB-3), Mobiluncus species, Trichomonas vaginalis, Neisseria gonorrhoeae, Candida species, Herpes simplex viruses 1 and 2, vaginal-fluid, reported as detected or not detected for each organism

Associated ICD-10 Diagnosis CodesICD-10

B37.31	Acute candidiasis of vulva and vagina
B37.32	Chronic candidiasis of vulva and vagina
B37.9	Candidiasis, unspecified
L29.2	Pruritus vulvae
L29.3	Anogenital pruritus, unspecified
L29.9	Pruritus, unspecified
N76.0	Acute vaginitis
N76.1	Subacute and chronic vaginitis
N76.2	Acute vulvitis
N76.3	Subacute and chronic vulvitis

1–10 of 19

1/2

inv-09: G. vaginalis quantitative threshold (example from SureSwab)

G. vaginalis quantitative threshold>= 6.0 log cells/mL is used to classify specimens (e.g., supportive or equivocal for BV in SureSwab)

Classification useG. vaginalis <6.0 log cells/mL contributes to 'not supportive' classifications

Equivocal criterionG. vaginalis >=6.0 log cells/mL with presence of Lactobacillus and/or A. vaginae/Megasphaera can be 'equivocal'

Supportive criterionG. vaginalis >=6.0 log cells/mL plus absence of Lactobacillus and presence of A. vaginae and/or Megasphaera is 'supportive' of BV

Provider Requirements and Actionable Rules

Prior Authorization

Prior Authorization Required for Inpatient Procedures

For services described in this policy, precertification/preauthorization IS REQUIRED for all products if the procedure is performed inpatient. When performed outpatient, prior authorization is not required for Commercial PPO and Indemnity and for Medicare HMO BlueSM (see member contract for details).

Inpatient = Prior authorization required for all products
Outpatient = Prior authorization not required for Commercial PPO and Indemnity; Medicare HMO BlueSM outpatient prior auth not required — verify member contract

Denial Risk

Investigational Use Triggers Denial

Multitarget PCR testing for diagnosis of bacterial vaginosis is considered INVESTIGATIONAL and will be denied when used outside the covered scenario: testing must be for symptomatic individuals, used as an alternative to Amsel criteria or Gram stain with Nugent scoring, performed using FDA-cleared assays, and on specimens collected by the prescribing provider. Any use outside these conditions is investigational and not covered.

Clinical Background

Bacterial vaginosis (BV) is caused by an imbalance of normal vaginal flora, characterized by depletion of hydrogen peroxide–producing Lactobacillus species and overgrowth of anaerobic bacteria such as Gardnerella vaginalis and other BV‑associated organisms. Most cases may be asymptomatic, while symptomatic patients typically present with vaginal discharge and odor; diagnosis is commonly made using clinical criteria (Amsel) and microscopic evaluation (Gram stain with Nugent scoring). Multitarget PCR assays detect and may quantify multiple BV‑associated organisms and can be used as an alternative diagnostic method when the policy’s criteria are met.

Definitions and Test Types

inv-19: Multitarget PCR testing — examples and specimen context

Examples of assaysSureSwab Total (Quest Diagnostics), BD Max (Becton, Dickinson), Aptima BV Assay (Hologic)

Specimen typeVaginal swab specimens collected for provider-collected testing

Analyte and result formatExtracts nucleic acid and detects/quantitates multiple BV-associated organisms reported as qualitative or quantitative results

Reporting approachSome assays report organism concentrations (log cells/mL) while others report a qualitative BV result (positive/negative) based on relative quantities

inv-21: Molecular PCR assays and Nugent/Gram stain context

Nugent score / Gram stainStandardized Gram stain interpretation method for diagnosing bacterial vaginosis (Nugent RP et al.), used as a reference comparator in validation studies