ModifiedCapital BluecrossPolicy 2.246

Genetic Testing for Familial Cutaneous Malignant Melanoma (CDKN2A, CDK4)

This policy governs coverage of genetic testing for genes associated with familial cutaneous malignant melanoma (primarily CDKN2A and CDK4) for Capital Blue Cross products; it applies to providers ordering such testing and to claims adjudication under applicable member benefit programs.

Policy Summary

PayerCapital Bluecross

PolicyGenetic Testing for Familial Cutaneous Malignant Melanoma (CDKN2A, CDK4)

Policy CodePolicy 2.246

Change TypeMajor review — policy statement changed to investigationalcoding updated

Effective DateJan 1, 2026

Next Review Date

Key ActionCheck member-specific benefits and avoid using investigational procedure codes 81403, 81404, or 81479 for CDKN2A/CDK4 testing as they are not covered.

SourceLink

POLICY UPDATE CHANGES

Policy statement changed to investigational (INV).

Procedure code 81403 was added to the coding table.

Code 81404 is now listed as investigational/not covered in the coding table.

InvestigationalCoverage stance for CDKN2A and CDK4 testing

3Procedure codes investigational/not covered

01/01/2026Policy effective

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Coverage Determination

inv-01: Investigational / Not covered — coverage determination

Coverage determination:

Investigational determination: Genetic testing for genes associated with familial cutaneous malignant melanoma or associated with susceptibility to cutaneous malignant melanoma is considered investigational due to insufficient evidence of clinical utility and impact on health outcomes.

Management currently does not change based on identified variants; evidence insufficient.

inv-02: Overall policy stance (investigational)

Policy-level coverage stance

Policy stance: Genetic testing of CDKN2A and CDK4 for familial cutaneous malignant melanoma is designated investigational (INV) in the updated policy.

See prior sections of the policy for any specific medical necessity exceptions or covered criteria; in this document procedure codes 81403, 81404, and 81479 are listed as investigational/not covered.

Genetic testing for CDKN2A and CDK4 is designated investigational and is therefore not covered when used to evaluate susceptibility to familial cutaneous malignant melanoma. Procedure codes associated with this testing are listed as investigational in the coding section and claims for these tests may be denied.

Testing billed with procedure codes 81403, 81404, or 81479 for evaluation of CDKN2A and CDK4 is considered investigational and is not covered under this policy.

Clinical management for patients with melanoma or those considered high risk focuses on sun avoidance, routine use of sunscreen, vigilant cutaneous surveillance, and prompt biopsy of suspicious lesions. Because these management recommendations do not currently change based on identification of genetic variants in familial CMM genes, genetic testing has not demonstrated sufficient clinical utility to alter care pathways.

The policy statement was changed to investigational after the 06/24/2025 major review. Tests designated investigational under this policy are considered not medically necessary for coverage purposes; consequently, testing for CDKN2A and CDK4 using the listed procedure codes is not covered.

inv-24: Covered indications — none specified; overall policy stance updated to investigational

Covered indications — none specified

Covered indications: No covered indications for genetic testing of CDKN2A and CDK4 are specified in the current policy; the 06/24/2025 major review changed the policy statement to investigational.

Prior versions included specific covered criteria but these have been superseded by the investigational policy stance.

Procedure Codes and Coding Notes

Investigational / not covered procedure codes for CDKN2A and CDK4CPTNot Covered

81403	Unlisted molecular pathology procedure (listed as investigational for CDKN2A/CDK4 testing)
81404	Targeted genomic sequence analysis (listed as investigational for CDKN2A/CDK4 testing)
81479	Unlisted molecular pathology procedure (listed as investigational for CDKN2A/CDK4 testing)

Investigational / Not Covered Procedure CodesCPTNot Covered

81403	Unlisted molecular pathology procedure (listed as investigational for testing CDKN2A and CDK4)
81404	Targeted genomic sequence analysis (listed as investigational for testing CDKN2A and CDK4)
81479	Unlisted molecular pathology procedure (listed as investigational for testing CDKN2A and CDK4)

Coding notemixed

No codes listed

Coding considerations

Coding noteThis coding list may not be all-inclusive; identification of a code does not denote coverage — coverage is determined by member benefit terms.

Codes subject to changeCodes in this section are subject to change at any time; verify current CPT descriptions before billing.

Reimbursement guidanceNot all covered services are eligible for separate reimbursement; presence of a code does not guarantee separate payment.

Provider Responsibilities and Billing Guidance

Prior Authorization

Product variation / benefit check

This policy applies only to certain Capital BlueCross products and may be subject to member-specific benefit variations. Providers should verify product-specific coverage, prior authorization requirements, and any limitations with the member's benefit plan before ordering genetic testing.

FEP PPO: Refer to FEP Medical Policy Manual (https://www.fepblue.org/benefit-plans/medical-policies-and-utilization-managementguidelines/medical-policies)

Denial Risk

Investigational test codes — denial risk

Genetic testing for CDKN2A and CDK4 is considered investigational for familial cutaneous malignant melanoma and may be denied as not covered. Claims for testing these genes billed with listed procedure codes are at risk for denial.

Investigational procedure codes associated with denial risk: 81403, 81404, 81479

Patient Eligibility and Testing Criteria

A genetic predisposition to cutaneous malignant melanoma is suspected in individuals with a positive family history (multiple affected family members), in patients with multiple primary melanomas, or with early age of onset. Although these clinical features may indicate hereditary risk, the policy designates genetic testing for CDKN2A and CDK4 as investigational and not covered.

Services Considered Not Covered

Genetic testing specifically for CDKN2A and CDK4 is designated investigational and is not covered under this policy.

Genetic testing for CDKN2A and CDK4 remains classified as investigational and not covered; therefore, claims for these tests may be denied.

Procedure codes 81403, 81404, and 81479 are listed as investigational and are not covered when used for testing of CDKN2A and CDK4.

Clinical Background

A familial predisposition to cutaneous malignant melanoma is suggested by multiple affected family members, multiple primary melanomas in a single patient, or early onset of disease. The principal high-penetrance genes implicated are CDKN2A and CDK4, with other loci and low-to-moderate penetrance genes (e.g., MC1R) acting as modifiers. Current evidence indicates that identifying germline variants in these genes does not meaningfully change surveillance or treatment strategies, and clinical utility has not been demonstrated.

Definitions and Terminology

ALLELE(S)

DefinitionOne of two or more different genes containing specific inheritable characteristics that occupy corresponding positions (loci) on paired chromosomes.

ContextUsed to describe variant forms of a gene relevant to hereditary melanoma risk assessment.

Clinical relevanceAllele identification is essential to report specific germline variants when genetic testing is performed.

PREDISPOSITION

DefinitionA latent susceptibility to disease which may be activated under certain conditions, as by stress.

Clinical implicationIndicates increased risk for disease (e.g., melanoma) that may inform surveillance decisions in some contexts.