CurrentAmbetter NevadaPolicy N/A

General Approach to Genetic and Molecular Testing

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Defines criteria, definitions, and clinical framework for coverage of genetic and molecular tests (including prenatal diagnosis, single-gene and multigene panels, tumor biomarker and algorithmic tests) used by the payer for members in applicable jurisdictions.

Policy Summary

PayerAmbetter Nevada

PolicyGeneral Approach to Genetic and Molecular Testing

Policy CodePolicy N/A

Change TypeConsolidation & criteria updates

Effective Date

Next Review Date

Key ActionObtain and document pre-test genetic counseling before ordering prenatal genetic tests and confirm prior molecular diagnosis when assessing recurrence risk.

SourceLink

POLICY UPDATE CHANGES

Removed age restriction criteria from the General Criteria for Single Gene or Multigene Panel Analysis for adult onset tests and require clinical features of the condition instead.

Added Prenatal Diagnosis for Genetic Conditions to this policy (moved from the GT: Prenatal Diagnosis policy).

Updated definition of targeted prenatal screening to include full gene sequencing or targeted mutation analysis for pathogenic or likely pathogenic variants.

Moved criteria for Tumor Biomarker Analysis and Oncology Algorithmic Tests under General Criteria for Other Tests (removed separate criteria sets).

Replaced the term 'investigational' with language beginning 'Current evidence does not support...' throughout the policy.

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CurrentAmbetter NevadaPolicy N/A

General Approach to Genetic and Molecular Testing

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Sign up for all Ambetter Nevada policy alerts

Know when Ambetter Nevada releases new policies or updates existing guidance.

Monitor payer policy activity

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Policy Summary

PayerAmbetter Nevada

PolicyGeneral Approach to Genetic and Molecular Testing

Policy CodePolicy N/A

Change TypeConsolidation & criteria updates

Effective Date

Next Review Date

Key ActionObtain and document pre-test genetic counseling before ordering prenatal genetic tests and confirm prior molecular diagnosis when assessing recurrence risk.

SourceLink

POLICY UPDATE CHANGES

Removed age restriction criteria from the General Criteria for Single Gene or Multigene Panel Analysis for adult onset tests and require clinical features of the condition instead.

Added Prenatal Diagnosis for Genetic Conditions to this policy (moved from the GT: Prenatal Diagnosis policy).

Updated definition of targeted prenatal screening to include full gene sequencing or targeted mutation analysis for pathogenic or likely pathogenic variants.

Moved criteria for Tumor Biomarker Analysis and Oncology Algorithmic Tests under General Criteria for Other Tests (removed separate criteria sets).

Replaced the term 'investigational' with language beginning 'Current evidence does not support...' throughout the policy.

V1.2025version

semi-annualreview cadence

Prenatal includednew content

Tumor criteria movedconsolidation

Coverage Criteria for Genetic and Molecular Testing

Prenatal Diagnosis and Counseling

Covered when criteria and counseling are met and when test results would reasonably affect pregnancy management or childhood care.

Professional guidance on adult-onset conditions: NSGC does not recommend prenatal genetic testing for known adult-onset conditions if pregnancy or childhood management will not be affected; consideration of testing requires pre-test genetic counseling by a genetic counselor or other healthcare specialist with genetics expertise to discuss natural history, available interventions, ethical implications, future autonomy, and potential for genetic discrimination.

From NSGC position statement

Indications for offering prenatal aneuploidy assessment: All pregnant women should be offered prenatal assessment for aneuploidy by screening or diagnostic testing; patients with increased risk include: older maternal or paternal age, prior child with structural birth defect, previous fetus or child with autosomal trisomy or sex chromosome aneuploidy, structural anomalies on ultrasound, parental carrier of chromosome rearrangement, parental aneuploidy or mosaicism, parental carrier of a genetic disorder, or an affected biological parent with an autosomal dominant disorder.

From ACOG guidance and CDC/ACCE lists

Pretest counseling and informed consent: Pretest counseling must be provided before ordering any genetic prenatal test and must include discussion of test performance, types of potential results (positive, negative, uncertain), sensitivity and specificity, residual risk, possible need for follow-up diagnostic testing, risks, limitations, benefits, and the patient's option to decline testing.

From ACOG committee opinion

Testing only when results will affect management: Prenatal diagnostic testing is covered when results would reasonably alter pregnancy management, perinatal care, or expected childhood management; testing for adult-onset conditions without such impact should generally be deferred and is not routinely recommended.

Operational consolidation and NSGC guidance (policy V1.2025)

Documentation and prior confirmation when assessing recurrence: When testing for recurrence following a previously affected child, molecular confirmation of the diagnosis in the affected child is generally necessary to ensure that testing in the current pregnancy will be informative; documentation of counseling and informed consent must be included in the medical record.

From ACOG and CDC; prior diagnostic confirmation requirement

General Test Evaluation Criteria

Coverage is considered when tests demonstrate analytic validity, clinical validity, and clinical utility appropriate to the intended use.

Apply ACCE evaluation framework: Evaluate analytic validity, clinical validity, clinical utility, and ethical/legal/social implications using the ACCE model; document sensitivity, specificity, positive and negative predictive values as applicable to the intended clinical context.

CDC ACCE Model

Analytic validity requirements: The test must demonstrate reliable and reproducible laboratory performance (analytic validity) for the analytes reported, appropriate quality controls, and methods suited to the specimen type and intended variant classes.

ACCE/standard laboratory evaluation (see CDC guidance)

Clinical validity requirements: Evidence must show the test accurately identifies or predicts the clinical condition or biomarker of interest (clinical validity), with measures such as sensitivity, specificity, positive predictive value, and negative predictive value appropriate to the intended diagnostic or screening use.

Burke/NIH definitions of clinical validity

Oncology and Tumor Biomarker Test Criteria

Covered when tumor biomarker or algorithmic tests demonstrate high analytical validity and evidence of improved outcomes or actionable clinical utility for the intended use.

Analytic validity and assay performance: The assay must demonstrate high analytical validity with validated methods, appropriate sensitivity/specificity for the analytes measured, and reproducible performance in the intended specimen types and clinical setting.

General Criteria for Oncology Algorithmic/Other Tests

Clinical evidence of improved outcomes or actionable utility: High-level clinical evidence is required that use of the tumor biomarker or algorithmic test leads to improved patient outcomes or provides actionable information that changes management in a way expected to improve outcomes compared with not using the test.

Hayes, AACC, and consolidated policy criteria

Clear intended use and endpoints: The intended use (eg, diagnosis, prognosis, therapy selection, monitoring) and clinically relevant endpoints must be explicitly defined and supported by evidence demonstrating benefit for that use.

Hayes et al recommended considerations

Prenatal genetic testing for known adult-onset conditions is addressed conservatively. Per the National Society of Genetic Counselors (NSGC) position, prenatal testing for known adult-onset conditions is not recommended if pregnancy or childhood management will not be affected; prospective parents should meet with a genetic counselor or other genetics-trained clinician to review implications before testing. Pre-test counseling should include discussion of the natural history of the condition, availability of treatments or interventions, potential impacts on the child's future autonomy, and risk of genetic discrimination. ACOG guidance further supports offering prenatal assessment for aneuploidy to all pregnant women and reserving diagnostic testing for those with increased risk (for example, advanced parental age, prior affected child, ultrasonographic structural anomalies, parental carrier status, or an affected biological parent).

Where the policy states that "current evidence does not support" the analytic validity, clinical validity, or clinical utility of a test for a given indication, the test may be determined to be not medically necessary. This phrasing replaces prior uses of the term "investigational" and means that coverage is not supported when the available evidence does not demonstrate sufficient validity or that test results and subsequent interventions improve health outcomes.

Indications Considered Medically Necessary

Prenatal assessment for aneuploidy and diagnostic testing

Prenatal assessment for aneuploidy is offered broadly; diagnostic testing is covered for pregnancies with increased risk factors.

Offer prenatal aneuploidy assessment to: All pregnant women (screening or diagnostic as appropriate) should be offered prenatal assessment for aneuploidy regardless of maternal age or other baseline risk factors.

ACOG practice bulletin

Criteria indicating increased risk warranting diagnostic testing: One or more of the following: older maternal or paternal age, prior child with a structural birth defect, previous fetus or child with autosomal trisomy or sex chromosome aneuploidy, structural anomalies identified by ultrasound, parental carrier of a chromosome rearrangement, parental aneuploidy or mosaicism, parental carrier of a genetic disorder, or a biological parent affected by an autosomal dominant disorder.

ACOG and CDC lists

Requirement for recurrence assessment: When testing is being performed to assess recurrence risk after an affected child, molecular confirmation of the diagnosis in the affected child is usually necessary to ensure the testing will be informative for the current pregnancy.

Eligibility Requirements and Preconditions

When testing is performed to assess recurrence risk after a previously affected child, the policy requires that the diagnosis in the affected child be established by molecular testing. Confirmation by molecular testing of the affected child is necessary to ensure that testing for future pregnancies will be informative and that recurrence risk has been accurately assessed.

Provider Responsibilities and Prior Actions

Prior Authorization

Coverage Decision and Review

Coverage of genetic testing and prenatal diagnostic tests is determined according to the member's plan terms and applicable law. Prior review (prior authorization) may be required for some prenatal and single-gene genetic tests. Coverage decisions are made based on medical necessity, current evidence of clinical validity and utility, and alignment with applicable guidelines. Providers should verify benefits and obtain any required prior authorization before ordering testing.

Verify member eligibility and benefits before ordering tests
Obtain prior authorization when required by the plan

Denial Risk

Denial Risk — Evidence and Benefit Coverage

Tests lacking sufficient evidence of clinical validity or clinical utility may be denied. When evidence does not support that a test will inform clinical management or improve health outcomes, coverage may be declined per plan terms.

Tests and Scenarios Not Covered

The National Society of Genetic Counselors (NSGC) position is that prenatal testing for known adult-onset conditions should generally be deferred when pregnancy or childhood management will not be affected. This reflects concern for medical and ethical complexities, potential effects on a child's future autonomy, and the need for genetic counseling to discuss implications before testing; such testing may therefore not be covered when it would not affect pregnancy or childhood care.

Key Definitions

Adult-onset condition — definition

DefinitionAn adult-onset condition is one in which the signs, symptoms, or manifestations of a disease typically begin after a person is age 18 years or older.

Clinical relevanceTypically not expected to cause signs or require management during childhood; implications for timing of testing and disclosure should consider autonomy and future-onset risk.

Policy implicationPrenatal testing for known adult-onset conditions is not recommended when pregnancy or childhood management will not be affected (see coverage criteria).

Clinical validity — definition and metrics

DefinitionClinical validity describes the accuracy with which a test identifies a particular clinical condition.

MetricsSensitivity: among people with the condition, the proportion with a positive test result; Specificity: among people without the condition, the proportion with a negative test result.

Background and Evidence Frameworks

The policy evaluation framework references the CDC ACCE model and major professional guidance (ACOG, NSGC) when assessing tests for analytic validity, clinical validity, and clinical utility. The ACCE process provides a structured set of questions covering analytic and clinical validity, clinical utility, and ethical/legal/social issues; ACOG and NSGC guidance are cited for expectations about pretest counseling, discussion of test performance (including sensitivity, specificity, predictive values), and the circumstances in which prenatal or predictive testing is appropriate.

Policy Summary

PayerAmbetter Nevada

PolicyGeneral Approach to Genetic and Molecular Testing

Policy CodePolicy N/A

Change TypeConsolidation & criteria updates

Effective Date

Next Review Date

Key ActionObtain and document pre-test genetic counseling before ordering prenatal genetic tests and confirm prior molecular diagnosis when assessing recurrence risk.

SourceLink

On This Page

Clinical utility requirements: Clinical utility must be demonstrated by evidence that test results and any subsequent interventions lead to improved health outcomes or meaningful clinical management changes compared with not testing.

Burke/NIH clinical utility definition

Intended-use distinctions: For diagnostic use, emphasis is on clinical validity and downstream impact on management; for screening or population-level use, emphasize analytic validity, appropriate predictive values, and evidence that screening leads to net clinical benefit.

Hayes and guideline distinctions

Evidence standards for coverage: Coverage decisions require high-quality evidence commensurate with the claim (diagnostic, prognostic, predictive), including clinical studies showing outcome benefit or clear actionable utility; tests lacking such evidence may be deemed not medically necessary ('current evidence does not support...').

Policy replacement of 'investigational' language; Hayes et al guidance

Algorithmic/multianalyte-specific considerations: For multianalyte algorithmic tests, the algorithm must be transparently described or validated, and clinical validation should demonstrate that the algorithmic result outperforms standard care or individual biomarkers in clinically meaningful ways.

Policy consolidation and Hayes guidance

Regulatory and guideline context: Consideration should be given to existing clinical practice guidelines, FDA approvals/clearances, and national coverage determinations; state-level regulations may also apply prior to coverage determination.

Policy note regarding guidelines and regulatory review

CDC/ACOG guidance on prior diagnostic confirmation

Pretest counseling prior to diagnostic testing: Pretest counseling must be provided and documented prior to ordering diagnostic prenatal tests and should include explanation of test performance, possible results, limitations, sensitivity/specificity, residual risk, and the option to decline testing.

ACOG committee opinion on counseling

Tumor biomarker and algorithmic tests

Tumor biomarker and algorithmic tests are covered only when they meet high analytic and clinical evidence standards demonstrating clinical benefit or actionable utility.

High analytical validity required: The test must demonstrate validated, reproducible analytic performance (sensitivity, specificity) for the reported analytes and specimen types.

ACCE/CDC analytic validity expectations

Evidence of improved outcomes or actionable clinical utility: There must be peer-reviewed, high-quality evidence that use of the tumor biomarker or algorithmic test leads to improved clinical outcomes or provides actionable information that changes management in ways expected to improve outcomes compared to not using the test.

Hayes et al guidance on clinical utility

Algorithm transparency and validation: For algorithmic or multianalyte tests, the algorithm and component analytes must be described and clinically validated; clinical validation should show superiority or meaningful added value versus standard care or individual markers.

Hayes and policy consolidation notes

Alignment with guidelines and regulatory status: Consideration should be given to clinical practice guidelines, FDA approvals/clearances, and national or local coverage determinations when assessing coverage; state-level regulations may necessitate additional review.

Policy V2.2024/V1.2025 consolidation notes

Denial may be issued when testing is investigational, experimental, or not supported by guidelines
Documentation of clinical rationale and relevant literature may be required to overturn a denial

Documentation Required

Pretest Counseling and Documentation

Pretest counseling must be documented in the medical record prior to ordering prenatal genetic testing. Counseling should include test purpose, possible result types (positive, negative, uncertain/variant of unknown significance), sensitivity and specificity where applicable, positive and negative predictive values related to the patient’s a priori risk, risks and limitations of testing, potential need for follow-up diagnostic testing, and alternatives including the right to decline testing.

Document that counseling was performed by qualified personnel
Include discussion of test performance (sensitivity, specificity), residual risk, and implications of positive/negative/indeterminate results
Document informed consent and that patient had opportunity to decline testing

Note

Prior Diagnostic Confirmation

When assessing recurrence risk or considering targeted prenatal testing based on a prior affected child, molecular confirmation of the diagnosis in the affected child is generally required to ensure that testing in the pregnancy will be informative. If a prior diagnosis was not molecularly confirmed, providers should obtain confirmatory testing of the affected relative when feasible before ordering targeted prenatal testing.

Molecular confirmation of the previously affected child is expected when available to guide recurrence testing
If confirmation is unavailable, document why and the clinical rationale for proceeding with testing

Predictive valuesPositive predictive value (PPV): among people with a positive test result, the proportion who have the condition; Negative predictive value (NPV): among people with a negative test result, the proportion who do not have the condition.

Clinical utility — definition

DefinitionClinical utility refers to the risks and benefits resulting from genetic test use, focusing on whether the test and any subsequent interventions lead to improved health outcomes and what risks occur as a result of testing.

Decision factorsAssessment includes magnitude of outcome improvement, availability and effectiveness of interventions, and the risk tolerance of stakeholders.

Evidence requirementFor tumor biomarker or algorithmic tests, clinical utility requires high analytical validity and high-level evidence showing improved outcomes compared with not knowing the test results.

Close relatives — definition

DefinitionClose relatives include first-, second-, and third-degree blood relatives as defined in the policy.

First-degree relativesParents, siblings, and children.

Second-degree relativesGrandparents, aunts, uncles, nieces, nephews, grandchildren, and half-siblings.

Third-degree relativesGreat grandparents, great aunts, great uncles, great grandchildren, and first cousins.