Whole Exome and Whole Genome Sequencing (Non-Oncology Conditions)
Defines clinical background, evidence summaries, and coding/applicability information for WES, WGS, and related genomic/transcriptomic/epigenetic assays for non-oncology indications; intended for clinicians and payers applying UnitedHealthcare New Jersey policy.
Genetic counseling recommended prior to WES/WGS to inform persons about test advantages and limitations.
Epigenetic signature analysis is considered unproven and not medically necessary for any indication due to insufficient evidence of efficacy.
Replaced phrase 'Whole genome optical mapping is considered unproven and not medically necessary' with 'optical genome mapping (OGM) is considered unproven and not medically necessary'.
Policy applicability clarified to outpatient testing or testing upon discharge from inpatient setting.
Coverage criteria updated: WES/WGS, with or without concurrent Comparator Analysis, is proven and medically necessary when listed criteria are met.
Removed requirement that WGS coverage requires prior CMA or WES not performed or nondiagnostic.
Revised coverage criterion to require signs/symptoms of undiagnosed disorder with suspected genetic cause and that results are intended to directly impact medical management.
Defined 'multiple congenital anomalies' as affecting at least two different organ systems.
Clarified reanalysis is medically necessary when listed criteria met and at least 18 months have passed since initial test.
Added non-concurrent comparator analysis coverage when prior WES/WGS was previously performed and criteria met.
Added CPT codes 0318U, 0582U, 0583U, and 81354 to applicable codes list.
Noted 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 NJ Medicaid.
Updated definitions for Comparator Analysis, Global Developmental Delay, Intellectual Disability, and Preimplantation Genetic Testing (PGT).
Documentation requirements clarified: records must support medical necessity, be legible, maintained, and made available upon request.
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