Clarification Regarding Coverage for the VisibiliT™ Test



    Purpose
    The purpose of this article is to communicate that the VisibiliT™ test (represented by procedure code 0009M) is medically necessary with criteria since this code's effective date of 07/01/2015. This communication supersedes any previous communications for 0009M from the Company.

    Policy Impacted
    7/1/2015 CPT & HCPCS Quarterly Code Update Coverage Determinations (ONLY FOR 0009M)
    MA06.017a: Molecular Diagnostics

    Background
    0009M represents the test called VisibiliT™, which is one of commercially available nucleic acid sequencing–based tests of maternal plasma. Specifically, VisibiliT™ is intended for usage in pregnancies that are not high-risk singleton pregnancies.


    Coverage Statement

    The coverage statements outlined for 0009M in this communication supersede any previous communications for 0009M from the Company.

    MEDICALLY NECESSARY
    Nucleic acid sequencing-based testing of maternal plasma as a screen for fetal aneuploidy (Trisomies 21, 13, 18) is considered medically necessary and, therefore, covered in women with singleton pregnancies undergoing screening for fetal aneuploidy.

    EXPERIMENTAL/INVESTIGATIONAL
    Nucleic acid sequencing-based testing of maternal plasma for fetal aneuploidy is considered experimental/investigational and, therefore, not covered in women with twin or multiple gestation pregnancies because the safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature.

    Nucleic acid sequencing-based testing of maternal plasma for fetal sex chromosome aneuploidies is considered experimental/investigational and, therefore, not covered in because the safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature.

    REQUIRED DOCUMENTATION
    The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

    The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.

    Coding
    Effective July 1, 2015, there is a Multianalyte Assays with Algorithmic Analyses (MAAA) procedure code specific to the VisibiliT™ test: 0009M.


    Issued on - 09/09/2015


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