Whole Exome and Whole Genome Sequencing - OXHP Whole Genome Sequencing (WGS) and Whole Exome Sequencing

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  • Whole Exome and Whole Genome Sequencing Page 1 of 14 UnitedHealthcare Oxford Clinical Policy Effective 03/01/2018

    ©1996-2018, Oxford Health Plans, LLC

    WHOLE EXOME AND WHOLE GENOME SEQUENCING Policy Number: LABORATORY 024.2 T2 Effective Date: March 1, 2018 Table of Contents Page INSTRUCTIONS FOR USE .......................................... 1 CONDITIONS OF COVERAGE ...................................... 1 BENEFIT CONSIDERATIONS ...................................... 2 COVERAGE RATIONALE ............................................. 2 DEFINITIONS .......................................................... 3 APPLICABLE CODES ................................................. 3 DESCRIPTION OF SERVICES ...................................... 3 CLINICAL EVIDENCE ................................................. 4 U.S. FOOD AND DRUG ADMINISTRATION ................... 10 REFERENCES .......................................................... 10 POLICY HISTORY/REVISION INFORMATION ................ 13 INSTRUCTIONS FOR USE

    This Clinical Policy provides assistance in interpreting Oxford benefit plans. Unless otherwise stated, Oxford policies do not apply to Medicare Advantage members. Oxford reserves the right, in its sole discretion, to modify its policies as necessary. This Clinical Policy is provided for informational purposes. It does not constitute medical advice. The term Oxford includes Oxford Health Plans, LLC and all of its subsidiaries as appropriate for these policies. When deciding coverage, the member specific benefit plan document must be referenced. The terms of the member specific benefit plan document [e.g., Certificate of Coverage (COC), Schedule of Benefits (SOB), and/or Summary Plan

    Description (SPD)] may differ greatly from the standard benefit plan upon which this Clinical Policy is based. In the event of a conflict, the member specific benefit plan document supersedes this Clinical Policy. All reviewers must first

    identify member eligibility, any federal or state regulatory requirements, and the member specific benefit plan coverage prior to use of this Clinical Policy. Other Policies may apply. UnitedHealthcare may also use tools developed by third parties, such as the MCG™ Care Guidelines, to assist us in administering health benefits. The MCG™ Care Guidelines are intended to be used in connection with the independent professional medical judgment of a qualified health care provider and do not constitute the practice of medicine or medical advice.

    CONDITIONS OF COVERAGE

    Applicable Lines of Business/ Products This policy applies to Oxford Commercial plan membership.

    Benefit Type General Benefits Package

    Referral Required (Does not apply to non-gatekeeper products)

    No

    Authorization Required (Precertification always required for inpatient admission)

    Yes1

    Precertification with Medical Director Review Required Yes1

    Applicable Site(s) of Service (If site of service is not listed, Medical Director review is required)

    Laboratory

    Special Considerations 1Precertification with review by a Medical Director or their designee is required.

    Related Policies

     Chromosome Microarray Testing

     Molecular Oncology Testing for Cancer Diagnosis, Prognosis, and Treatment Decisions

    UnitedHealthcare® Oxford

    Clinical Policy

    https://www.oxhp.com/secure/policy/chromosome_microarray_testing.pdf https://www.oxhp.com/secure/policy/molecular_oncology_testing_cancer_dx_prognosis_tx_decisions.pdf https://www.oxhp.com/secure/policy/molecular_oncology_testing_cancer_dx_prognosis_tx_decisions.pdf

  • Whole Exome and Whole Genome Sequencing Page 2 of 14 UnitedHealthcare Oxford Clinical Policy Effective 03/01/2018

    ©1996-2018, Oxford Health Plans, LLC

    BENEFIT CONSIDERATIONS Before using this policy, please check the member specific benefit plan document and any federal or state mandates, if applicable.

    Essential Health Benefits for Individual and Small Group

    For plan years beginning on or after January 1, 2014, the Affordable Care Act of 2010 (ACA) requires fully insured

    non-grandfathered individual and small group plans (inside and outside of Exchanges) to provide coverage for ten categories of Essential Health Benefits (“EHBs”). Large group plans (both self-funded and fully insured), and small group ASO plans, are not subject to the requirement to offer coverage for EHBs. However, if such plans choose to provide coverage for benefits which are deemed EHBs, the ACA requires all dollar limits on those benefits to be removed on all Grandfathered and Non-Grandfathered plans. The determination of which benefits constitute EHBs is made on a state by state basis. As such, when using this policy, it is important to refer to the member specific benefit plan document to determine benefit coverage.

    COVERAGE RATIONALE Genetic counseling is strongly recommended prior to these tests in order to inform persons being tested about the advantages and limitations of the test as applied to a unique person.

    Whole Exome Sequencing (WES)

    Whole Exome Sequencing (WES) is proven and/or medically necessary for diagnosing or evaluating a genetic disorder when the results are expected to directly influence medical management and clinical outcomes AND ALL of the following criteria are met:  Clinical presentation is nonspecific and does not fit a well-defined syndrome for which a specific or targeted gene

    test is available. If a specific genetic syndrome is suspected, a single gene or targeted gene panel should be

    performed prior to determining if WES is necessary; and  WES is ordered by a board-certified medical geneticist , neonatologist, neurologist, or developmental and

    behavioral pediatrician; and  One of the following:

    o The clinical presentation or clinical and family history strongly suggest a genetic cause for which a specific clinical diagnosis cannot be made with any clinically available targeted genetic tests; or

    o There is a clinical diagnosis of a genetic condition where there is significant genetic heterogeneity and WES is a more practical approach to identifying the underlying genetic cause than are individual tests of multiple

    genes; or o There is likely a genetic disorder and multiple targeted gene tests that have failed to identify the underlying

    cause. Comparator (e.g., parents or siblings) WES is proven and/or medically necessary for evaluating a genetic disorder when the above criteria have been met and WES is performed concurrently or has been previously performed on the individual.

    WES is unproven and/or not medically necessary for all other indications, including but not limited to the following:  Screening and evaluating disorders in individuals when the above criteria are not met  Prenatal genetic diagnosis or screening  Evaluation of fetal demise  Preimplantation genetic diagnosis or screening in embryos  Molecular profiling of tumors for the diagnosis, prognosis or management of cancer

    Further studies are needed to evaluate the clinical utility of whole exome sequencing for other indications. Whole Genome Sequencing (WGS)

    Whole Genome Sequencing (WGS) is unproven and/or not medically necessary for screening and evaluating any disorder. Although WGS has the potential to identify causal variants for a wide variety of conditions that may be missed with other technologies, as well as to identify predictive biomarkers, the information derived from WGS has not yet been translated into improved outcomes and changed medical management. Further studies are needed to establish the clinical utility of WGS.

  • Whole Exome and Whole Genome Sequencing Page 3 of 14 UnitedHealthcare Oxford Clinical Policy Effective 03/01/2018

    ©1996-2018, Oxford Health Plans, LLC

    DEFINITIONS Comparator: A DNA sequence that is used to compare to the individual’s DNA sequence. This may be a parent or sibling of the individual, or non-cancerous tissue that is being compared to the individual’s tumor tissue (Thun et al.,

    2017).

    Next Generation Sequencing (NGS): New sequencing techniques that can quickly analyze multiple sections of DNA at the same time. Older forms of sequencing could only analyze one section of DNA at once. Variant of Unknown Significance (VUS): A variation in a genetic sequence that has an unknown association with disease. It may also be called an unclassified variant. Whole Exome Sequencing (WES): About 1% of a person’s DNA makes protein. These protein making sections are

    called exons. All the exons together are called the exome. WES is a DNA analysis technique that looks at all of the exons in a person at one time, rather than gene by gene (U.S. National Library of Medicine, 2017A). Whole Genome Sequencing (WGS): WGS determines the sequence of all of the DNA in a person, which includes the protein making (coding) as well as non-coding DNA elements (U.S. National Library of Medicine, 2017B).

    APPLICABLE CODES

    The following list(s) of procedure and/or diagnosis codes is provided for reference purposes only and may not be all inclusive. Listing of a code in this policy does not imply that the service described by the code is a covered or non- covered health service. Benefit coverage for health services is determined by the member specific benefit plan document and applicable laws that may require coverage for a specific service. The inclusion of a code does not imply any right to reimbursement or guara