CurrentIndependent HealthPolicy M011001298

Molecular Diagnostic Testing, Genetic Testing and Genetic Counseling

Medical necessity criteria, prior authorization, and counseling requirements for germline and somatic molecular diagnostic and genetic testing for Independent Health members across listed lines of business.

Policy Summary

PayerIndependent Health

PolicyMolecular Diagnostic Testing, Genetic Testing and Genetic Counseling

Policy CodePolicy M011001298

Change TypeNo material changes

Effective Date5/9/2002

Next Review Date

Key ActionOrdering or rendering laboratory must secure prior authorization and submit required clinical documentation before molecular or genetic testing.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

once per lifetimeCarrier testing limit

requiredPrior authorization

<=10Panel excess gene limit

multiple LOBsApplies to

Coverage Criteria

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Medical necessity criteria

Covered when ALL of the following are met

Medical necessity criteria: The requested molecular diagnostic/genetic test has been shown to have clinical validity and clinical utility

Per-gene relevance: Each individual gene requested has clinical utility and relevance

Panel size: The number of genes or tests is reasonable and necessary to obtain necessary information for therapeutic decision making (excess genes in multigene testing should be limited; excess genes likely would not exceed 10)<= ~10 excess genes

Clinical presentation: The member displays clinical features of a germline or somatic condition that requires treatment

Impact on treatment: The result of the test will directly impact the treatment being delivered to the member

Documentation - order: Documentation includes the physician's order when the request is submitted by a laboratory

Prior evaluation: After history, physical examination, pedigree analysis, genetic counseling, and completion of conventional diagnostic studies, a definitive diagnosis remains uncertain

Documentation - consent: Documentation of the member's informed consent is presented with the test order

Requests for genetic testing that are initiated solely because a member obtained a direct-to-consumer or other home genetic test (for example, Ancestry.com or 23andMe) are not covered.

Carrier testing for spinal muscular atrophy (SMA) and cystic fibrosis is limited to once per lifetime; any carrier testing for these conditions performed more than once per lifetime is not covered.

Repeat molecular diagnostic or genetic testing for the same germline or somatic condition is not covered. Duplicate or serial testing without new clinical indications that change management is excluded.

Genetic testing performed primarily to guide the medical management of family members who are not covered under the member's contract is not covered.

Repeat or duplicate genetic testing and testing driven solely by results from consumer/home direct‑to‑consumer tests (e.g., Ancestry, 23andMe) are considered not covered and are excluded from benefits.

Covered Indications

Establishing a molecular diagnosis when clinical validity/utility demonstrated and results impact treatment

Covered when ALL of the following are met

Covered indication: Testing is intended to establish a molecular diagnosis of a germline or somatic mutation when clinical validity and clinical utility are demonstrated

Includes diagnostic, predictive, and reproductive genetic testing when criteria met; preconception/prenatal carrier screening for SMA and Cystic Fibrosis is considered medically necessary as part of routine care

Per-gene relevance: Each individual gene requested has clinical utility and relevance

Panel size: The number of genes or tests is reasonable and necessary for therapeutic decision making; when multigene testing includes genes without proven utility, excess genes must be limited (likely would not exceed 10 genes)<= ~10 excess genes

Results affect management: Results of the testing must directly impact treatment or management of the member

Carrier screening guidance: Based upon professional guidance, preconception or prenatal carrier screening for SMA and Cystic Fibrosis is considered medically necessary as routine care; carrier testing for SMA and Cystic Fibrosis should be performed only once per lifetimeonce per lifetime for SMA and CF carrier testing

Not indicated by home test: Requests resulting solely from a member-acquired home test (e.g., Ancestry or 23andMe) are not considered an indication for molecular diagnostic testing

Provider Actions & Requirements

Prior Authorization

Prior authorization required

Prior authorization is required for molecular diagnostic and genetic testing; the ordering/rendering laboratory is responsible for securing prior authorization and submitting clinical information to support the request.

Step Therapy

Tiered testing / step approach

When multigene testing is available in a tiered approach, coverage is limited to testing where the results will directly impact management and the number of genes is reasonable and necessary (excess genes should be limited and likely would not exceed 10).

Documentation Required

Required documentation for prior authorization

Documentation submitted for prior authorization must include the physician's order when the request is submitted by a laboratory, relevant member-level clinical information, and the member's informed consent as presented with the test order.

Denial Risk

Denial if no prior authorization

Claims for molecular diagnostic testing received without prior authorization will deny to the responsibility of the rendering laboratory; Independent Health members shall not be billed.

Note

Offer testing with trained professionals for pre/post-test counseling

Genetic testing should be offered only in settings with adequately trained health care professionals who provide pre- and post-test genetic counseling; documentation of genetic counseling and informed consent is required prior to testing.

Note

Order tests with appropriate clinical evaluation and physician order

Tests must be ordered in the context of an appropriate clinical evaluation; if the laboratory submits the request, a physician's order must be included and the ordering/referring physician must supply relevant clinical information to support the request.

Definitions

Clinical utility

DefinitionClinical utility is the evidence of improved measurable clinical outcomes, and a test's usefulness and added value to patient management and decision making compared with current management in the absence of testing

Evidence requirementClinical utility must be demonstrated for the requested molecular diagnostic/genetic test as part of medical necessity criteria

Impact on careTests with clinical utility should directly influence treatment or management decisions for the member

Clinical validity

DefinitionClinical validity is the accuracy of a test for a specific clinical purpose, such as diagnosis or prediction of a risk of a disorder

Requirement for coverageRequested molecular diagnostic/genetic tests must have demonstrated clinical validity to be considered medically necessary

PurposeClinical validity pertains to test accuracy for intended clinical use (diagnosis, risk prediction)

Genetic counseling

DefinitionGenetic counseling is the process by which patients or relatives at risk are advised of the consequences and nature of the disorder, the probability of developing or transmitting it, and options for management and family planning

DocumentationDocumentation of genetic counseling and informed consent is required prior to testing and is part of medical necessity criteria

Provider qualificationsGenetic testing should be offered in a setting with adequately trained health care professionals (certified genetic counselors or clinicians with extensive training/expertise)

Germline mutation

DefinitionGermline mutation is a gene change in a body's reproductive cell (egg or sperm) that becomes incorporated into the DNA of every cell in the offspring and is passed on from parents to offspring

ImplicationGermline mutations are hereditary and relevant to diagnostic, predictive, and reproductive genetic testing covered when criteria met

Coverage contextEstablishing a molecular diagnosis of a germline mutation requires demonstration of clinical validity/utility and that results will directly impact treatment

Somatic mutation

DefinitionSomatic mutation is an alteration in DNA that occurs after conception in any body cell except sperm and egg and therefore is not passed on to children

Clinical relevanceSomatic mutations can cause cancer or other diseases and establishing a molecular diagnosis of somatic mutation requires clinical validity/utility and impact on treatment

Coverage contextMolecular diagnostic testing for somatic mutations is considered medically necessary when all coverage criteria are met, including impact on therapeutic decision making

Eligibility Requirements

Members with a personal or family history suggestive of a hereditary condition should be referred to a qualified genetics professional for assessment. A pedigree analysis (family history) is expected as part of the evaluation prior to advanced molecular or genetic testing.

Before advanced molecular or genetic testing is pursued, conventional diagnostic studies (history, physical exam, and appropriate conventional testing) should be completed. Testing is appropriate only when a definitive diagnosis remains uncertain after these evaluations and genetic counseling.