CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Multitarget Polymerase Chain Reaction Testing for Diagnosis of Bacterial Vaginosis

Defines medical coverage stance for specific multitarget PCR assays to diagnose bacterial vaginosis for Medicare Advantage and Commercial products offered by Blue Cross Blue Shield of Rhode Island, including which assays/CPT codes are considered medically necessary and which are not covered.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyMultitarget Polymerase Chain Reaction Testing for Diagnosis of Bacterial Vaginosis

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateMar 1, 2026

Next Review DateN/A

Key ActionOrdering physicians must obtain any prior authorization and handle appeals themselves; laboratories and third parties must not obtain authorization or participate on behalf of the ordering physician.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4multitarget PCR tests addressed

3tests considered medically necessary

1test not covered / not medically necessary

~84-95% / 85-97%reported sensitivity / specificity ranges in validation studies

Medically Necessary and Not Covered Multitarget PCR Tests for Bacterial Vaginosis

Medically Necessary — Medicare Advantage and Commercial Products

The following multitarget PCR tests for the diagnosis of bacterial vaginosis may be considered medically necessary:

ANY of the following

Aptima® BV Assay (Hologic, Inc.) — CPT 81513
BD MAX™ Vaginal Panel (Becton Dickinson and Company) — CPT 81514
Xpert® Xpress MVP (Cepheid) — CPT 81515

Not Covered / Not Medically Necessary — Medicare Advantage and Commercial Products

The following multitarget PCR test is considered not covered for Medicare Advantage and not medically necessary for Commercial Products:

ALL of the following must be met

Bridge Women's Health Infectious Disease Detection Test (Bridge Diagnostics) — CPT 0330U
Evidence insufficient to demonstrate improvement in net health outcome

Relevant CPT and ICD-10 Codes

Covered CPT codes (with ICD-10 requirement)CPTCovered

81513	Aptima BV Assay: quantitative real-time amplification of RNA markers for Atopobium vaginae, Gardnerella vaginalis, and Lactobacillus species; algorithm reported as positive/negative for BV
81514	BD MAX Vaginal Panel: quantitative real-time amplification of DNA markers for Gardnerella vaginalis, Atopobium vaginae, Megasphaera type 1, BVAB-2, Lactobacillus species; includes separate detection of Trichomonas and Candida species when reported
81515	Xpert Xpress MVP: real-time PCR amplification of DNA markers for Atopobium vaginae/species, Megasphaera type 1, BVAB-2; includes separate detection of Trichomonas and Candida species when reported

Not covered / not medically necessary CPT codeCPTNot Covered

0330U

Bridge Women's Health Infectious Disease Detection Test: vaginal pathogen panel identification of 27 organisms; amplified probe technique — not covered / not medically necessary

ICD-10 allowed diagnosis codes for 81513 and 81514ICD-10

B37.31	Candidal vulvovaginitis
B37.32	Candidal vulvovaginitis, other
B37.9	Candidiasis, unspecified
L29.2	Pruritus of female genital organs
L29.3	Pruritus of external genital organs
L29.9	Pruritus, unspecified
N76.0	Acute vaginitis
N76.1	Subacute and chronic vaginitis
N76.2	Other inflammatory diseases of vagina
N76.3	Vulvitis and vulvovaginitis

1–10 of 19

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Authorization, Documentation, and Billing Rules

Documentation Required

Ordering physician must handle prior authorization and appeals

Only the ordering physician may obtain authorizations, file appeals, or otherwise participate in the authorization process; laboratories and third parties are prohibited from obtaining authorization or participating on behalf of the ordering physician. Violation may result in termination from the BCBSRI provider network and financial liability for unauthorized laboratory services.

Laboratories and third parties are prohibited from obtaining authorization or participating in the authorization process on behalf of the ordering physician; violations may result in termination from the BCBSRI provider network and financial liability for unauthorized laboratory services.

Clinical and Test Performance Context

Bacterial vaginosis (BV) is a common condition caused by an imbalance in the normal vaginal bacterial flora, typically characterized by depletion of hydrogen peroxide–producing Lactobacillus species, a rise in vaginal pH, and overgrowth of other organisms such as Gardnerella vaginalis, Mycoplasma hominis, Mobiluncus species and other anaerobic gram-negative rods. Vaginal culture is not an appropriate diagnostic method for BV because the condition reflects a shift in the overall microbial community rather than the presence of a single etiologic organism.

Multitarget polymerase chain reaction (PCR) tests are nucleic acid amplification assays that detect and/or quantify multiple microorganisms associated with BV from vaginal-fluid specimens and report results by an algorithm as a positive or negative indication for bacterial vaginosis. These assays can be qualitative or quantitative and are designed to detect several BV-associated targets concurrently, which may include combinations of Gardnerella vaginalis, Atopobium (or Atopobium species), Megasphaera type 1, BV-associated bacteria-2 (BVAB-2), and Lactobacillus species. Examples addressed by this policy include the Aptima® BV Assay, BD MAX™ Vaginal Panel, Bridge Women’s Health Infectious Disease Detection Test, and Xpert® Xpress MVP.

Technical performance studies of commercially available multitarget PCR assays have shown diagnostic sensitivities in the range of approximately 84%–95% and specificities of approximately 85%–97% when compared with standard diagnostic methods (most studies used a combination of the Amsel criteria and Nugent score as the reference standard). However, there is limited direct evidence that multitarget PCR testing improves clinical management or patient outcomes compared with the standard clinical and microscopic evaluation, and the evidence is considered insufficient to demonstrate improved net health outcomes for some assays.

Defined Terms

Definitions

Multitarget PCR testingNucleic acid amplification tests that detect and/or quantify multiple microorganisms associated with BV from vaginal-fluid specimens, reported by algorithm as positive or negative for bacterial vaginosis.

Medically necessary (as used)Services considered appropriate based on available evidence and covered by Medicare Advantage and Commercial Products per this policy when specified.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyMultitarget Polymerase Chain Reaction Testing for Diagnosis of Bacterial Vaginosis

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateMar 1, 2026

Next Review DateN/A

SourceLink

On This Page

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Multitarget Polymerase Chain Reaction Testing for Diagnosis of Bacterial Vaginosis

Medically Necessary and Not Covered Multitarget PCR Tests for Bacterial Vaginosis

Relevant CPT and ICD-10 Codes

Authorization, Documentation, and Billing Rules

Clinical and Test Performance Context

Defined Terms

Policy Dates and Review

Multitarget Polymerase Chain Reaction Testing for Diagnosis of Bacterial Vaginosis

Medically Necessary and Not Covered Multitarget PCR Tests for Bacterial Vaginosis

Relevant CPT and ICD-10 Codes

Authorization, Documentation, and Billing Rules

Clinical and Test Performance Context

Defined Terms

Additional Policies to Review

Policy Dates and Review