DraftBlue Cross Blue Shield - Rhode IslandPolicy N/A

Multitarget Polymerase Chain Reaction Testing for Diagnosis of Bacterial Vaginosis

This policy governs coverage determinations for commercially available multitarget polymerase chain reaction tests to diagnose bacterial vaginosis for Medicare Advantage and commercial products offered by Blue Cross Blue Shield of Rhode Island.

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 change

Effective DateJul 1, 202617d

Next Review DateMar 18, 2026

Key ActionFile services with a covered ICD-10-CM diagnosis code and ensure only the ordering physician handles authorization and appeals.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4tests addressed by policy

3covered CPT codes

1not covered CPT codes

Sens 84-95% / Spec 85-97%reported accuracy

Coverage determinations

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inv-01: Coverage stance by specific test

Coverage determinations by test:

Aptima, BD MAX, Xpert coverage: Aptima (81513), BD MAX (81514), and Xpert Xpress MVP (81515) may be considered medically necessary when filed with a covered ICD-10-CM diagnosis code.

Medicare Advantage Plans and Commercial Products: covered when filed with covered diagnosis codes (see Coding section).

Bridge test not covered: Bridge Women's Health Infectious Disease Detection Test (0330U) is not covered for Medicare Advantage Plans and not medically necessary for Commercial Products.

Insufficient evidence to demonstrate improvement in net health outcome; lack of clinical utility evidence and most symptomatic individuals can be diagnosed with standard workup.

Bridge Women's Health Infectious Disease Detection Test (0330U) is not covered for Medicare Advantage Plans and is considered not medically necessary for Commercial Products. The code descriptor for 0330U is: "Infectious agent detection by nucleic acid (DNA or RNA), vaginal pathogen panel, identification of 27 organisms, amplified probe technique, vaginal swab."

Medically necessary indications

inv-13: Diagnosis of bacterial vaginosis in individuals with a covered ICD-10-CM diagnosis code.

Covered when ALL of the following are met:

Indication: The individual has a clinical indication consistent with bacterial vaginosis (signs or symptoms) and the test is ordered for diagnosis of bacterial vaginosis.

See Definitions and Background for common clinical presentation and reference standards (Amsel criteria, Nugent score).

Test-specific filing requirement: The Aptima (81513), BD MAX (81514), or Xpert Xpress MVP (81515) CPT code is filed with a covered ICD-10-CM diagnosis code listed in the Coding section.

Refer to the policy's ICD-10 mapping for the specific codes applicable to each CPT. Services must be filed with a covered diagnosis to be considered medically necessary.

Laboratory and ordering requirements: The test is performed by a CLIA/CAP-certified laboratory and only the ordering physician is involved in authorization/appeal processes; laboratories may not obtain authorization on behalf of the ordering physician.

Laboratories found to have obtained authorization on behalf of ordering physicians may be subject to sanction; unauthorized services may be denied as the laboratory's financial liability.

Procedure and diagnosis codes

Multitarget PCR CPT/PLA codes referencedmixed

81513	Aptima BV Assay — 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	BD MAX Vaginal Panel — 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	Xpert Xpress MVP — 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
0330U	Bridge Women's Health Infectious Disease Detection Test — infectious agent detection by nucleic acid (DNA or RNA), vaginal pathogen panel, identification of 27 organisms, amplified probe technique, vaginal swab

Associated ICD-10 diagnosis codesICD-10

ICD-10 list

ICD-10 diagnosis codes are listed as required when filing CPT codes 81513, 81514, and 81515; specific mapping entries are provided in the policy (see ICD-10 diagnosis code(s) list for CPT codes 81513, 81514 and ICD-10 Diagnosis Code List for 81515).

Authorization, documentation, and billing rules for providers

Prior Authorization

Not applicable

Documentation Required

Provider involvement required

Only the ordering physician may be involved in authorizations, appeals, or other administrative processes related to prior authorization or medical necessity. Laboratories are not allowed to obtain clinical authorization or participate in the authorization process on behalf of the ordering physician.

Denial Risk

Authorization ownership and prohibited assistance

In no circumstance shall a laboratory, a physician/provider, a laboratory representative, or any third party obtain authorization on behalf of the ordering physician, facilitate any portion of the authorization process, or participate in appeals where the authorization process was not followed. If a laboratory or third party supports any portion of the authorization process, BCBSRI will deem this a violation and may take severe action up to and including termination from the BCBSRI provider network.

Denial Risk

Laboratory authorization prohibition and denial risk

If a laboratory provides a laboratory service that has not been authorized, the service will be denied and the financial liability will be the responsibility of the participating laboratory; the service may not be billed to the member.

Ordering and authorization rules

Step Therapy

ORDERING REQUIREMENTS: ordering physician-only authorization

Only the ordering physician may obtain authorizations and pursue appeals; laboratories and laboratory representatives are not permitted to obtain authorization on behalf of the ordering physician.

Laboratories may not participate in the authorization process for the ordering physician.
Using a laboratory representative or third party to obtain authorization or support an appeal is prohibited.

Excluded tests

Bridge Women's Health Infectious Disease Detection Test (0330U) is not covered / not medically necessary. The policy lists 0330U specifically as not covered for Medicare Advantage and not medically necessary for Commercial Products, citing insufficient evidence of improved net health outcome and lack of demonstrated clinical utility.

Clinical background

Bacterial vaginosis (BV) is an imbalance of the normal vaginal flora, typically characterized by depletion of Lactobacillus species and overgrowth of anaerobic organisms such as Gardnerella vaginalis and others. Most symptomatic cases are diagnosed by clinical criteria and microscopy (eg, Amsel criteria or Nugent score), while multitarget PCR assays detect and quantify multiple BV-associated organisms from vaginal fluid specimens to report an algorithmic positive/negative result.

Key definitions

Multitarget PCR testing — definition and characteristics

DefinitionNucleic acid amplification methods that measure multiple organisms associated with bacterial vaginosis (BV) simultaneously and report an algorithmic positive/negative result for BV.

Test types includedCommercial multitarget PCR assays addressed: Aptima BV Assay (81513), BD MAX Vaginal Panel (81514), Xpert Xpress MVP (81515), and Bridge Women's Health Infectious Disease Detection Test (0330U).

Specimen and targetsUses vaginal fluid specimens to detect and quantify DNA/RNA markers for multiple organisms (eg, Gardnerella vaginalis, Atopobium vaginae, Megasphaera, BV-associated bacteria, and Lactobacillus species).

Result formatReported as qualitative algorithmic positive/negative for BV or as qualitative/quantitative detection of specific organisms depending on the assay.

Clinical roleProposed as an alternative to clinical and microscopic evaluations; may improve diagnosis if shown to be more accurate and reliable than standard methods.

Reference standard — common diagnostic reference standards (Amsel, Nugent)

Common reference standardsAmsel criteria and Nugent scoring are commonly used BV diagnostic reference standards in studies.

Amsel criteriaClinical and microscopic evaluation-based diagnostic criteria commonly used in practice and research to diagnose symptomatic BV.

Nugent scoringMicroscopic Gram-stain–based scoring system to evaluate vaginal flora composition and quantify BV-associated bacterial morphotypes.