RetiredCareSourcePolicy MM-T140

Genetic Testing and Counseling

Coverage and medical necessity requirements for inherited and somatic genetic testing and required genetic counseling for CareSource members in Arkansas. Governs documentation, prior authorization, and review processes for genetic assays.

Policy Summary

PayerCareSource

PolicyGenetic Testing and Counseling

Policy CodePolicy MM-T140

Change TypeNo material changes

Effective Date01/01/2022

Next Review Date

Key ActionInclude documentation of family history, pretest genetic counseling, and informed consent with prior authorization for inherited genetic testing.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

01/01/2022Effective date

08/31/2022Archived date

MM-T140Policy identifier

RequiredCounseling requirement

MCGSomatic testing review basis

Coverage and Medical Necessity Criteria

Inherited Genetic Testing - Medical Necessity

Covered when ALL of the following are met:

Inherited testing requirements: Documentation of family history, pretest genetic counseling, and fully informed consent must be provided; counseling must be by a clinician trained in relevant genetic issues and provided prior to testing (and included with prior authorization).

Genetic counseling is required for all inherited genetic mutation testing.

Somatic Genetic Testing - Review Criteria

Somatic testing coverage and review:

Somatic testing review: Somatic genetic mutation testing does not require the genetic counseling described for inherited testing and will be reviewed using published MCG criteria and the Medical Necessity Determinations Administrative Policy.

Panel vs Individual Test Coverage

Policy Summary

PayerCareSource

PolicyGenetic Testing and Counseling

Policy CodePolicy MM-T140

Change TypeNo material changes

Effective Date01/01/2022

Next Review Date

Key ActionInclude documentation of family history, pretest genetic counseling, and informed consent with prior authorization for inherited genetic testing.

SourceLink

On This Page

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Provider Requirements, Documentation, and Authorization

Prior Authorization

Prior Authorization Required for Inherited and Proprietary Panels

Prior authorization requests for inherited and proprietary panel testing must include documentation of pretest genetic counseling and a detailed family history. Providers should attach the genetic counseling notes and pedigree information to the prior authorization submission.

Pretest genetic counseling documentation must be provided with the prior authorization request.
Detailed family history / pedigree demonstrating relevant affected relatives must be included.

Note

Sequential Testing When Panels Not Supported

When a requested multi-gene or proprietary panel is not supported as medically necessary, providers may request sequential single-gene or targeted testing. Each individual test requested in sequence must meet medical necessity criteria and include the required documentation (see documentation callout).

Individual tests may be requested separately when a panel is not medically necessary.
Each sequential test requires its own medical necessity justification and supporting documentation.

Documentation Required

Required Documentation for Inherited Testing

Providers must include the following documentation for all inherited genetic testing requests: a documented family history/pedigree, evidence of pretest genetic counseling, and documentation of informed consent that addresses potential outcomes and implications. Counseling documentation should describe the counseling session content, who provided counseling (name and credentials), and confirmation that alternative options and implications for relatives were discussed.

Family history / pedigree with relevant affected and unaffected relatives and ages of onset.
Pretest genetic counseling notes summarizing topics discussed.
Signed informed consent specific to the genetic test, including discussion of possible results and their implications.

Denial Risk

Documentation and Counseling Absent — Denial Risk

If the required documentation (family history, pretest genetic counseling, or informed consent) is absent or incomplete at the time of review, the request may be returned for additional information or denied. Lack of counseling documentation may result in denial of coverage for the inherited genetic test.

Missing or incomplete family history, counseling notes, or informed consent may trigger denial.
Requests may be returned to the provider to submit the missing documentation prior to approval.

Eligibility and Authorization Requirements

For inherited (germline) genetic testing, documentation of a family history relevant to the requested testing is required and must be provided with the authorization request. The clinician must include family history along with evidence of pretest genetic counseling and a fully informed consent when seeking prior authorization.

The policy does not mandate specific prior tests before authorization. Somatic (tumor/acquired) genetic testing does not require genetic counseling and will be reviewed using published MCG criteria and the Medical Necessity Determinations Administrative Policy. If a proprietary or multigene panel does not meet medical necessity, individual genetic tests may be requested separately per the Medical Necessity Determinations Administrative Policy.

Definitions

Genetic Counseling — Definition and who may perform it

DefinitionThe process of education and recommendations provided by a trained professional regarding genetic issues; a specialized skill set that may be performed by clinicians who receive appropriate training and have core competencies.

Who may perform itClinicians with appropriate training and core competencies, including non-genetic subspecialists (e.g., primary care physicians) who have developed relevant competencies for their practice area.

Required whenPretest genetic counseling is required for all inherited (germline) genetic mutation testing and documentation should be provided with prior authorization when applicable.

Genetic Testing — Definition of tests and targets

DefinitionAnalysis of human DNA, RNA, chromosomes, proteins, or certain metabolites to detect alterations, genotypes, mutations, phenotypes, or karyotypes related to a heritable or acquired disorder.

Targets includedDNA and RNA

Other analytesChromosomes, proteins, and certain metabolites

Clinical purposeDetection of alterations related to heritable (inherited) or acquired (somatic) disorders.

Inherited Genetic Mutation — Definition (germline/hereditary)

DefinitionA genetic mutation inherited from a mother or father that is present at birth; also referred to as a germline or hereditary mutation.

TimingPresent at birth (constitutional).

SynonymsGermline mutation; hereditary mutation.

Somatic Gene Mutation — Definition (acquired mutation, often associated with cancer)

DefinitionA genetic mutation that is acquired (not present at birth), often occurring during the process of cancer formation; may be referred to as an acquired mutation.

AssociationOften associated with cancer and targeted by precision medicine approaches.

TimingNot present at birth (somatic/acquired).

OpenPayer

Genetic Testing and Counseling

Coverage and Medical Necessity Criteria

Policy Identifiers and Codes

Provider Requirements, Documentation, and Authorization

Eligibility and Authorization Requirements

Definitions

Background and Rationale

Non-Covered Services