Whole Exome and Whole Genome Sequencing (Non-Oncology Conditions) (for New Jersey Only)
Outpatient and post-discharge coverage policy for Whole Exome Sequencing (WES) and Whole Genome Sequencing (WGS) for non-oncology conditions in New Jersey; defines medical necessity criteria, prenatal indications, reanalysis, comparator analysis, and not medically necessary uses.
Genetic counseling is recommended prior to Whole Exome Sequencing or Whole Genome Sequencing to inform persons about advantages and limitations.
Epigenetic signature analysis is considered unproven and not medically necessary for any indication due to insufficient evidence of efficacy.
Replaced wording to refer to 'optical genome mapping (OGM)' as unproven and not medically necessary.
Stated policy applicability only to testing in an outpatient setting or upon discharge from an inpatient setting.
Clarified WES/WGS coverage language to 'WES/WGS, with or without concurrent Comparator Analysis, is proven and medically necessary when [the listed] criteria are met'.
Removed requirement that WGS coverage required prior nondiagnostic CMA or WES.
Replaced and clarified multiple coverage criteria wording (e.g., impact on medical management, definition of well-delineated genetic syndrome, required organ systems for congenital anomalies, developmental regression exclusions).
Non-concurrent comparator analysis is proven and medically necessary when the affected individual meets WES/WGS criteria and prior WES/WGS has been performed.
Clarified reanalysis of WES or WGS data is proven and medically necessary when listed criteria are met, including at least 18 months since the initial testing and additional unexplained symptoms.
Medical records documentation language added clarifying that documentation may be required to assess criteria and that coverage is subject to federal, state, contractual requirements.
Added definitions for Autism Spectrum Disorder, Congenital Anomaly, and Epileptic Encephalopathy.
Added or updated multiple definitions (Comparator Analysis, Global Developmental Delay, Intellectual Disability, Preimplantation Genetic Testing) and removed definitions for NGS and VUS.
Added CPT codes 0318U, 0582U, 0583U, and 81354 to applicable codes.
Added notation that CPT codes 0318U, 0532U, 0567U, 0582U, and 0583U are not on the State of New Jersey Medicaid Fee Schedule and therefore may not be covered by the State of New Jersey Medicaid Program.
Documentation requirements described (relevant medical history, physical exam, and results of pertinent diagnostic tests); documentation must be legible, maintained in the patient's record, and available on request.
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