CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Medical Coverage Policy | Multitarget Polymerase Chain Reaction Testing for Diagnosis of Bacterial Vaginosis

Defines medical coverage positions for specific multitarget PCR tests (Aptima BV, BD MAX Vaginal Panel, Bridge Women's Health test, Xpert Xpress MVP, Xpert CT/NG) for diagnosis of bacterial vaginosis across Medicare Advantage and Commercial products, including CPT code mapping and ICD-10 diagnosis lists for covered codes.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyMultitarget Polymerase Chain Reaction Testing for Diagnosis of Bacterial Vaginosis

Policy CodePolicy N/A

Change TypeCoverage clarification (Medicare vs Commercial)

Effective DateJan 1, 2024

Next Review Date

Key ActionOrdering physician must handle authorization/appeals; laboratories may not obtain or participate in authorization on behalf of the ordering physician.

SourceLink

POLICY UPDATE CHANGES

Medicare Advantage Plans: Xpert CT/NG (0353U) covered without authorization; Commercial Products: Xpert CT/NG (0353U) not medically necessary.

Aptima BV (81513), BD MAX Vaginal Panel (81514), and Xpert Xpress MVP (0352U) are considered medically necessary for both Medicare Advantage and Commercial Products.

3Medically necessary (shared Medicare & Commercial)

2Not medically necessary / not covered

1Covered w/o auth (Medicare Advantage)

Coverage Summary

This policy defines coverage positions for specific multitarget PCR testing for diagnosis of bacterial vaginosis (Aptima BV 81513, BD MAX Vaginal Panel 81514, Bridge Women’s Health test 0330U, Xpert Xpress MVP 0352U, and Xpert CT/NG 0353U) across Medicare Advantage and Commercial products. The policy reflects a mixed coverage stance: some tests are considered medically necessary for both product types, one test is covered without authorization for Medicare Advantage but not medically necessary for Commercial products, and two tests are not covered/not medically necessary. Effective date: 01/01/2024. Policy last reviewed: 09/06/2023.

Key facts

SubjectMultitarget PCR testing for diagnosis of bacterial vaginosis

ScopeDefines medical coverage positions for specific multitarget PCR tests (Aptima BV, BD MAX Vaginal Panel, Bridge Women's Health test, Xpert Xpress MVP, Xpert CT/NG) for diagnosis of bacterial vaginosis across Medicare Advantage and Commercial products, including CPT code mapping and ICD-10 diagnosis lists for covered codes.

Coverage stanceMixed — some tests medically necessary for both Medicare Advantage and Commercial (Aptima BV 81513, BD MAX 81514, Xpert Xpress MVP 0352U); Bridge test (0330U) not covered/not medically necessary; Xpert CT/NG (0353U) covered without authorization for Medicare Advantage but not medically necessary for Commercial products.

Effective date01|01|2024

Last review09|06|2023

StatusCURRENT

Medical-Necessity Criteria

Medicare Advantage Plans coverage

Tests covered without authorization and tests considered medically necessary for Medicare Advantage:

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Not Medically Necessary / Not Covered

Across products, several multitarget PCR tests are designated as medically necessary (Aptima BV CPT 81513, BD MAX Vaginal Panel CPT 81514, Xpert Xpress MVP CPT 0352U) for both Medicare Advantage and Commercial Products. The Bridge Women’s Health Infectious Disease Detection Test (CPT 0330U) is not covered / not medically necessary for Medicare Advantage and not medically necessary for Commercial Products. Xpert CT/NG (CPT 0353U) is covered without authorization for Medicare Advantage but is listed as not medically necessary for Commercial Products.

Not covered / Not medically necessary

Tests explicitly listed as not covered / not medically necessary:

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Coding

Covered for Medicare Advantage (no auth)CPT|HCPCS|mixedCovered

0353U

Xpert® CT/NG - Infectious agent detection by nucleic acid (DNA), Chlamydia trachomatis and Neisseria gonorrhoeae, multiplex amplified probe technique, urine, vaginal, pharyngeal, or rectal, each pathogen reported as detected or not detected

Medically necessary (Medicare Advantage and Commercial when indicated) - Aptima BVCPTCovered

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

Medically necessary (Medicare Advantage and Commercial when indicated) - BD MAX Vaginal PanelCPTCovered

81514

Infectious disease, bacterial vaginosis and vaginitis, quantitative real-time amplification of DNA markers for Gardnerella vaginalis, Atopobium vaginae, Megasphaera type 1, 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

Medically necessary (Medicare Advantage and Commercial when indicated) - Xpert Xpress MVPHCPCS|CPTCovered

0352U

Xpert® Xpress MVP - Infectious disease (bacterial vaginosis and vaginitis), multiplex amplified probe technique, detection of BV-associated bacteria and separate detection of Candida species and Trichomonas vaginalis, vaginal-fluid specimen

Not covered / Not medically necessaryCPTNot Covered

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
0353U	Xpert® CT/NG - listed as not medically necessary for Commercial Products (see Medicare Advantage coverage exception)

Provider Actions

Documentation Required

Ordering physician must handle authorization/appeals

Laboratories are prohibited from obtaining or participating in prior authorization, appeals, or other administrative authorization processes on behalf of the ordering physician. Only the ordering physician may be involved in authorization, appeals, or other administrative processes related to prior authorization/medical necessity. If a laboratory or third party supports any portion of the authorization process or provides an unauthorized laboratory service, BCBSRI may take severe action up to and including termination from the provider network and hold the laboratory financially liable for denied services.

Ordering physician is responsible for authorization, appeals, and administrative processes.
Laboratories may not obtain authorization or facilitate appeals on behalf of the ordering physician.
Unauthorized lab services may be denied and billed to the laboratory, not the member; violations can lead to network termination.

Background and Evidence

Multitarget PCR assays amplify DNA or RNA from multiple organisms associated with BV and can report qualitative or quantitative results. Diagnostic accuracy studies have reported sensitivities of 84%–95% and specificities of 85%–97% versus standard reference methods. However, there is limited direct evidence of clinical utility showing that PCR testing leads to improved patient management or better health outcomes compared with standard clinical and microscopic evaluation.

Evidence metrics

Reported sensitivity range84%-95%

Reported specificity range85%-97%

Multitarget PCR testing: Polymerase chain reaction methods that extract and amplify DNA or RNA fragments using multiple targets to detect organisms associated with bacterial vaginosis; results may be qualitative or quantitative.

Revision History

2024-01-01policy_effective_date

Policy effective date established as 01/01/2024.

2023-09-06policy_last_review

Policy last reviewed on 09/06/2023.

2023-11coverage_clarificationLatest

Medicare Advantage Plans: Xpert CT/NG (CPT 0353U) covered without an authorization requirement. (Material change: clarifies Medicare Advantage coverage exception for 0353U.)