CurrentFidelis CarePolicy CP.FC.49

Clinical Policy: Genetic Testing

Defines medical necessity criteria for genetic tests when no specific policy exists for the requested test; includes general tumor biomarker analysis criteria and exclusions (e.g., DTC testing, genetic banking). Applies to all lines of business except Medicare.

Policy Summary

PayerFidelis Care

PolicyClinical Policy: Genetic Testing

Policy CodePolicy CP.FC.49

Change TypeAdded tumor biomarker criteriainvestigational determinationsLOB update

Effective DateApr 1, 2025

Next Review Date

Key ActionProviders must document clinical features or direct risk, clinical management impact, insufficiency of conventional diagnostics, prior testing history, and literature support for the test's clinical performance.

SourceLink

POLICY UPDATE CHANGES

Added section III: 'General Tumor Biomarker Analysis' and criteria.

Added section IV: 'General tumor biomarker analysis is considered investigational for all other indications.'

Changed Product type from 'All LOB' to 'All LOB Except Medicare'.

Annual reviews and reference updates recorded (3/23, 4/24, 12/24, 4/25).

3Major coverage sections (I-III)

2Explicit exclusions listed

1CLIA lab requirement for tumor testing

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Coverage Summary

This policy (Policy Number CP.FC.49) from Fidelis Care (All LOB Except Medicare) defines medical necessity criteria for genetic testing when no specific policy exists for the requested test. Effective/last review date: 4/2025. The policy outlines general coverage expectations and decision-making guidance to assist in coverage determinations for genetic tests not covered by other, test‑specific clinical policies.

Quick Facts

Policy NumberCP.FC.49

Effective Date2025-04-01

Last Review2025-04-01

Applies toAll LOB Except Medicare

StatusCURRENT

SubjectGenetic Testing

Medical-Necessity Criteria

General Genetic Testing - Medically Necessary

Genetic testing is medically necessary when ALL of the following criteria are met:

ALL of the following

The member/enrollee displays clinical features, or is at direct risk of having inherited the mutation or genetic disorder in question.
ALL of the following
- Clinically useful results allow providers to do at least ONE of the following
  - Inform interventions that could prevent or delay disease onset.
  - Detect disease at an earlier stage when treatment is more effective.

Not Medically Necessary / Investigational

Genetic Testing - Not Medically Necessary

All other requests for genetic testing that do not meet the above criteria are considered not medically necessary, including:

ANY of the following

Direct-to-consumer (DTC) genetic testing.
Genetic banking / DNA storage.
Other requests that do not meet the medical necessity criteria in Section I.

General Tumor Biomarker Analysis - Investigational

General tumor biomarker analysis is considered investigational for:

ANY of the following

Coding

No specific billing codes listedmixed

No codes listed

Provider Actions

Documentation Required

Clinical justification required

Providers must document the clinical justification for genetic testing, including that the member displays clinical features or is at direct risk for the genetic disorder; that test results will affect clinical management; that conventional diagnostic studies, pedigree analysis and genetic counseling (when available) are insufficient to make the diagnosis; prior genetic testing history (or rationale for repeat testing if prior testing exists); and that the clinical performance of the test is supported by published peer‑reviewed medical literature.

Billing Rule

Laboratory requirement for tumor biomarker testing

Tumor biomarker testing must be performed in a Clinical Laboratory Improvement Amendments (CLIA) approved laboratory to meet medical necessity for general tumor biomarker analysis.

Background

The purpose of this policy is to provide criteria for medical necessity determinations for genetic testing when no other clinical policy or decision-support criteria are available. The policy clarifies when genetic testing is appropriate to confirm or rule out suspected genetic conditions, predict disease risk, identify carrier status, and establish prenatal or clinical diagnoses or prognoses. It also guides review of genetic panels to determine whether each included gene analysis is medically necessary.

Genetic tests described include three principal methods: gene tests (DNA/RNA sequencing or probe-based assays to detect small or large alterations, copy number changes, or gene activity), chromosomal tests (karyotype and FISH to detect chromosome number and structural changes), and biochemical tests (measuring protein/enzyme amounts or activity, commonly used in newborn screening).

Intended use cases enumerated in the policy include: diagnosis of suspected inherited disorders, prediction of disease risk, carrier detection, prenatal diagnosis, and informing clinical prognosis and management. The policy emphasizes that testing should be used when results will lead to a clinically useful change in care (for example, prevention, earlier detection, management of disease progression, treatment of symptoms, or pregnancy decision‑making).

Special considerations for testing children are specified: testing should account for availability of evidence‑based risk‑reduction strategies and the likelihood of developing a serious condition during childhood. Unless a clinical intervention is appropriate in childhood, parents are encouraged to defer testing for adult‑onset conditions until the child reaches adulthood, with advocacy for the child’s best interests until they can decide for themselves.

Definitions

CLIA requirement for tumor biomarker testing

Revision History

4/2025revisionLatest

Annual review. References reviewed and updated.

12/2024revision

Changed Product type from 'All LOB' to 'All LOB Except Medicare'.

4/2024addition

Added section III: 'General Tumor Biomarker Analysis' and criteria; Added section IV: 'General tumor biomarker analysis is considered investigational for all other indications.' References reviewed and updated.

Policy Summary

PayerFidelis Care

PolicyClinical Policy: Genetic Testing

Policy CodePolicy CP.FC.49

Change TypeAdded tumor biomarker criteriainvestigational determinationsLOB update

Effective DateApr 1, 2025

Next Review Date

SourceLink

On This Page

Manage the treatable progression of an established disease.

Treat current symptoms significantly affecting a member/enrollee's health.

Guide decision making for the member/enrollee's current or planned pregnancy.

The genetic disorder could not be diagnosed through completion of conventional diagnostic studies, pedigree analysis and genetic counseling, when available.

The member/enrollee has not previously undergone genetic testing for the disorder, unless significant changes in testing technology or treatments indicate that test results or outcomes may change due to repeat testing.

Clinical performance of the genetic test is supported by published peer-reviewed medical literature.

General Tumor Biomarker Analysis - Medically Necessary

General tumor biomarker analysis is medically necessary when ALL of the following are met:

ALL of the following

The member/enrollee has a confirmed neoplasm and/or malignancy.
ALL of the following
- ANY of the following
  - The test will determine if a particular therapeutic intervention is effective (or ineffective) in the member/enrollee, or if a particular intervention may be harmful.
  - The test will directly impact the clinical management.
  - The test will determine prognosis.
The test shows clinical validity.
Testing is being performed in a Clinical Laboratory Improvement Amendments (CLIA) approved laboratory.

Testing in Children

ALL of the following

Testing should consider availability of evidence-based risk reduction strategies and the probability of developing a serious medical condition during childhood.
Unless there is a clinical intervention appropriate in childhood, parents should be encouraged to defer genetic testing for adult-onset conditions until adulthood.
Advocate for the best interests of the child until able to make the personal choice to have genetic testing.

All other indications not meeting the criteria in Section III.

Denial Risk

Requests not meeting criteria will be denied

Requests that do not meet the policy's medical necessity criteria are considered not medically necessary and may be denied. This includes direct‑to‑consumer (DTC) genetic testing and genetic banking/DNA storage, as well as other requests that fail to meet Section I or Section III criteria.

3/2023addition

Policy developed and approved. Added section III: 'General Tumor Biomarker Analysis' and criteria; Added section IV: 'General tumor biomarker analysis is considered investigational for all other indications.'