Investigational Miscellaneous Genetic and Molecular Tests

Policy Number: MA-2.277

Effective Date: 2/1/2026

Policy

All of the tests listed in this policy are considered investigational, and are grouped according to the categories of genetic testing as outlined in MP 2.326 General Approach to Genetic Testing:

• Testing of an affected (symptomatic) individual’s germline to benefit the individual (excluding reproductive testing)
• Diagnostic testing
• Prognostic testing
• Therapeutic testing
• Testing an asymptomatic individual to determine future risk of disease.

There is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with these tests.

Policy Guidelines

Genetic testing is considered investigational when criteria are not met, including when there is insufficient evidence to determine whether the technology improves health outcomes.

Genetic Counseling

Genetic counseling is primarily aimed at patients who are at risk for inherited disorders, and experts recommend formal genetic counseling in most cases when genetic testing for an inherited condition is considered. The interpretation of the results of genetic tests and the understanding of risk factors can be very difficult and complex. Therefore, genetic counseling will assist individuals in understanding the possible benefits and risks of genetic testing, including the possible impact of the information on the individual’s family. Genetic counseling may alter the utilization of genetic testing substantially and may reduce inappropriate testing. Genetic counseling should be performed by an individual with experience and expertise in genetic medicine and genetic testing methods.

Cross-References

• MP 2.326 General Approach to Genetic Testing

Product Variations

This policy is only applicable to certain programs and products administered by Capital Blue Cross and subject to benefit variations. Please see additional information below.

FEP PPO – Refer to FEP Medical Policy Manual.

Description/Background

There are numerous commercially available genetic and molecular diagnostic, prognostic, and therapeutic tests for individuals with certain diseases or asymptomatic individuals with future risk. This evidence review evaluates miscellaneous genetic and molecular tests not addressed in a separate review. If a separate evidence review exists, then conclusions reached there supersede conclusions here. The main criterion for inclusion in this review is the limited evidence on the clinical validity for the test. As a result, these tests do not have clinical utility, and the evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Tests Addressed in This Medical Policy

Tests assessed in this medical policy are listed in Table 1. All coding information is also found in this Table. Three types of tests are related to testing of an affected (symptomatic) individual’s germline to benefit the individual (excluding reproductive testing): diagnostic testing, prognostic testing, and therapeutic testing. The fourth type of test reviewed is testing of an asymptomatic individual to determine future risk of disease.

Note: Some genetic tests identified above do not have specific codes (i.e., GI Effects, Prometheus® Celiac, etc.); therefore, identification of a code in this section does not denote coverage. When several or all of the codes listed are used to identify these tests, they are considered investigational. The list of codes may not be all-inclusive and are subject to change at any time. Eligibility is determined by the terms of member benefit information. In addition, not all covered services are eligible for separate reimbursement.

Rationale

Summary of Evidence

The literature review was not comprehensive, but sufficient to establish lack of clinical utility. If it is determined that enough evidence has accumulated to reevaluate its potential clinical utility, the test will be removed from this evidence review and addressed separately. The lack of demonstrated clinical utility of these tests is based on the following factors: (1) there is no or extremely limited published data addressing the test; and/or (2) there is insufficient evidence demonstrating the clinical validity of the test.

Definitions

N/A

Disclaimer

Capital Blue Cross’ medical policies are used to determine coverage for specific medical technologies, procedures, equipment, and services. These medical policies do not constitute medical advice and are subject to change as required by law or applicable clinical evidence from independent treatment guidelines. Treating providers are solely responsible for medical advice and treatment of members. These polices are not a guarantee of coverage or payment. Payment of claims is subject to a determination regarding the member’s benefit program and eligibility on the date of service, and a determination that the services are medically necessary and appropriate. Final processing of a claim is based upon the terms of contract that applies to the members’ benefit program, including benefit limitations and exclusions. If a provider or a member has a question concerning this medical policy, please contact Capital Blue Cross’ Provider Services or Member Services.

References

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Policy History

• MA 2.277
• 9/22/2025 Creation of policy.