ModifiedCapital BluecrossPolicy 2.246

Genetic testing for familial cutaneous malignant melanoma (CDKN2A, CDK4)

Governs coverage of genetic testing for genes associated with familial cutaneous malignant melanoma (primarily CDKN2A and CDK4) for Capital BlueCross products; designates these tests as investigational and applies to designated programs where benefit variations exist.

Policy Summary

PayerCapital Bluecross

PolicyGenetic testing for familial cutaneous malignant melanoma (CDKN2A, CDK4)

Policy CodePolicy 2.246

Change TypePolicy statement revised to investigationalcoding table updated

Effective DateJan 1, 2026

Next Review Date

Key ActionDo not bill or expect coverage for CDKN2A/CDK4 testing using codes 81403, 81404, or 81479 because these are investigational and not covered.

SourceLink

POLICY UPDATE CHANGES

Policy statement changed to investigational (INV).

Procedure code 81403 was added to the coding table.

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

InvestigationalCoverage stance for CDKN2A and CDK4

3Procedure codes not covered

MajorLast review

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Coverage Criteria and Policy Statement

Investigational / Not Medically Necessary

Covered when ALL of the following are met

Investigational determination: Genetic testing for genes associated with familial cutaneous malignant melanoma (CDKN2A, CDK4) is considered investigational due to insufficient evidence of clinical utility

Policy states insufficient evidence to determine health outcomes; management does not change based on identified variants

Investigational

Policy stance updated

Policy stance: Genetic testing of CDKN2A and CDK4 is classified as investigational (INV) as of the 06/24/2025 major review.

See policy history for prior medically necessary language (e.g., criteria for 3+ invasive melanomas or melanoma with a relative with pancreatic cancer); current policy classifies testing as investigational and not covered.

Testing using procedure code(s) 81403, 81404, or 81479 for analysis of CDKN2A and CDK4 is considered investigational and is therefore not covered.

Use of procedure code(s) 81403, 81404, and 81479 when performed for CDKN2A and CDK4 testing is investigational and is excluded from coverage.

The rationale for the investigational determination is that current evidence does not demonstrate clinical utility for germline testing of genes associated with familial cutaneous malignant melanoma. Variant interpretation challenges, variable penetrance, and residual risk limit clinical validity, and identified genetic variants have not been shown to change management. Care for patients at increased risk remains focused on sun protection, use of sunscreen, vigilant cutaneous surveillance, and prompt biopsy of suspicious lesions rather than test-directed interventions.

The policy statement was revised to classify germline testing of CDKN2A and CDK4 as investigational during the 06/24/2025 major review. The update also revised the coding table and added procedure code 81403, with the result that codes 81403, 81404, and 81479 are listed as investigational when used for these genes.

Previously Considered Covered Indications / Clinical Context

Covered indications

Clinical situations suggesting a hereditary predisposition include, but are not limited to:

ONE of: Melanoma diagnosed in multiple family members (first- or second-degree relatives)

A positive family history is the most significant risk factor (approximately 10% report an affected first- or second-degree relative).

ONE of: Multiple primary melanomas in the same individual

Multiple primaries in one patient raise suspicion for hereditary predisposition.

ONE of: Early age of onset of cutaneous malignant melanoma

Early-onset disease can indicate inherited susceptibility.

Procedure Codes and Coding Notes

Investigational / Not Covered Procedure Codes for CDKN2A and CDK4CPTNot Covered

81403	Tier 2 - Molecular pathology procedure, Level 3 (listed as investigational for CDKN2A/CDK4 testing)
81404	Tier 2 - Molecular pathology procedure, Level 4 (listed as investigational for CDKN2A/CDK4 testing)
81479	Unlisted molecular pathology procedure (listed as investigational for CDKN2A/CDK4 testing)

Investigational / therefore not covered when used for testing CDKN2A and CDK4CPTNot Covered

81403
81404
81479

Investigational / therefore not covered when used for testing CDKN2A and CDK4CPTNot Covered

81403
81404
81479

Coding ancillary note

Coding noteIdentification of a code in the coding section does not denote coverage; coverage is determined by member benefit information.

ScopeCode lists may not be all-inclusive and are subject to change.

ReimbursementNot all covered services are eligible for separate reimbursement — verify benefit terms.

Provider Responsibilities and Actionable Notes

Prior Authorization

Product/Program Variations and Prior Authorization

This policy may not apply to all Capital BlueCross products and programs. Prior authorization, coverage rules, and benefit limits can vary by product; providers should verify applicability and authorization requirements using the member's specific benefit plan. FEP PPO members should refer to the FEP Medical Policy Manual.

Applicability varies by product and benefit plan — confirm prior authorization and coverage with member benefits.
FEP PPO: Refer to FEP Medical Policy Manual.

Denial Risk

Investigational Testing and Coding Impact

Genetic testing of CDKN2A and CDK4 for familial cutaneous malignant melanoma is considered investigational and is not covered. Use of the procedure codes listed below for CDKN2A and CDK4 testing may result in denial.

Investigational and not covered for CDKN2A and CDK4 testing: CPT 81403, 81404, 81479

Eligibility and Patient Selection

A family history with multiple affected relatives is the strongest indicator of a possible hereditary predisposition to cutaneous malignant melanoma and is the primary context in which consideration of genetic predisposition occurs. Although such family-history patterns raise suspicion for inherited risk, this policy does not authorize testing based on specific family-history criteria because testing of CDKN2A and CDK4 is classified as investigational.

Explicit Not Covered Services

Genetic testing for genes associated with familial cutaneous malignant melanoma, specifically CDKN2A and CDK4, is considered investigational and therefore not covered under this policy. The investigational determination applies to germline testing for these genes due to insufficient evidence of benefit to health outcomes.

When procedure codes 81403, 81404, or 81479 are used for testing CDKN2A and CDK4, those services are considered investigational and are not covered.

Background and Epidemiology

Familial predisposition to cutaneous malignant melanoma is suspected in clinical settings such as multiple affected family members, multiple primary melanomas in one individual, or early-onset disease. High-penetrance genes implicated include CDKN2A and CDK4, with modifiers such as MC1R noted. However, limitations in variant interpretation and variable penetrance mean that identifying a variant has not been shown to alter management or improve health outcomes, supporting the policy’s investigational stance.

Definitions

ALLELE(S)

TermALLELE(S)

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

ContextUsed in discussion of genetic variation and inheritance relevant to familial melanoma testing.

PREDISPOSITION

TermPREDISPOSITION

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

Context