CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Gene expression testing for pigmented lesions and cutaneous melanoma

Coverage policy for gene expression profiling tests used to evaluate suspicious pigmented lesions, melanocytic lesions with indeterminate histopathology, and AJCC stage I–II cutaneous melanoma (e.g., to guide biopsy decisions or sentinel lymph node biopsy). Affects providers submitting claims to Blue Cross Blue Shield - Rhode Island (BlueCHiP for Medicare and Commercial products).

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyGene expression testing for pigmented lesions and cutaneous melanoma

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 10, 2018

Next Review DateN/A

Key ActionObtain prior authorization for unlisted molecular/genetic tests (required for BlueCHiP for Medicare; recommended for Commercial products).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3clinical applications discussed

3named commercial tests

3unlisted CPT prior auth

Insufficientevidence conclusion

23+

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Coverage Determinations and Criteria

Coverage determinations

Policy coverage stance by product and indication

BlueCHiP for Medicare - Suspicious pigmented lesions: Gene expression testing in the evaluation of patients with suspicious pigmented lesions is not covered (evidence is insufficient to determine effects on health outcomes).

BlueCHiP for Medicare - Indeterminate histopathology: Gene expression testing in the evaluation of melanocytic lesions with indeterminate histopathologic features is not covered (evidence is insufficient to determine effects on health outcomes).

BlueCHiP for Medicare - Cutaneous melanoma: Gene expression testing in the evaluation of patients with cutaneous melanoma is not covered for all indications (evidence is insufficient to determine effects on health outcomes).

Benefits may vary between groups and contracts. Please refer to the appropriate Benefit Booklet, Evidence of Coverage, or Subscriber Agreement for the member's applicable coverage determinations and for whether services are considered not medically necessary or not covered.

Coverage and exclusions are governed by the member's subscriber agreement or employer agreement. This medical policy is provided for informational purposes and is not a guarantee of payment; member-specific benefits and eligibility should be verified through the provider call center or applicable plan documents.

For both Commercial Products and BlueCHiP for Medicare, gene expression testing for: (1) evaluation of suspicious pigmented lesions, (2) evaluation of melanocytic lesions with indeterminate histopathologic features, and (3) evaluation of cutaneous melanoma is not supported by sufficient evidence of clinical utility. For Commercial Products these tests are considered not medically necessary, and for BlueCHiP for Medicare they are not covered due to insufficient evidence to determine effects on health outcomes.

BlueCHiP for Medicare: Gene expression testing in the evaluation of suspicious pigmented lesions, indeterminate melanocytic histopathology, and cutaneous melanoma is not covered because the evidence is insufficient to determine the effects of the technology on health outcomes.

Intended Clinical Uses / Covered Indications

Tests intended to help decide whether to biopsy suspicious pigmented lesions, aid diagnosis of indeterminate histopathology, or determine SLNB in stage I–II melanoma

Tests intended to help decide whether to biopsy suspicious pigmented lesions, aid diagnosis of indeterminate histopathology, or determine SLNB in stage I–II melanoma.

Intended clinical uses: Tests measure gene expression to assist decisions about biopsy of suspicious pigmented lesions, aid diagnosis of melanocytic lesions with indeterminate histopathology, or help determine whether to perform sentinel lymph node biopsy (SLNB) in patients with AJCC stage I–II cutaneous melanoma.

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Coverage stance - BlueCHiP for Medicare: Gene expression testing for these intended uses is not covered because the evidence is insufficient to determine effects on health outcomes.

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Coverage stance - Commercial Products: Gene expression testing for these intended uses is considered not medically necessary because the evidence is insufficient to determine effects on health outcomes.

Tests Considered Not Covered / Not Medically Necessary

The following named commercial gene expression tests are specifically identified as not covered / not medically necessary for the policy indications because available evidence does not demonstrate clinical utility: Pigmented Lesion Assay (DermTech), myPath Melanoma, and DecisionDx‑Melanoma.

Coding and Billing

Unlisted CPT codes requiring prior authorizationCPT

81479	Unlisted molecular pathology procedure
81599	Unlisted multianalyte assay with algorithmic analysis
84999	Unlisted chemistry procedure

inv-07: Lesion diameter — >= 6 mm (ABCDE criterion)

Lesion diameter threshold>= 6 mm

ABCDE checklist itemDiameter ≥6 mm is one of the ABCDE features used to identify lesions suggestive of melanoma

Clinical contextDiameter ≥6 mm contributes to decision to refer for dermatology or biopsy as part of visual exam

Provider Actions, Prior Authorization, and Billing Risk

Prior Authorization

Provider Action: Prior Authorization & Billing Rules

Prior authorization is required for BlueCHiP for Medicare and is recommended for Commercial products. All unlisted genetic testing CPT codes require prior authorization to determine what service is being rendered and if the service is covered or medically necessary. Obtain prior authorization via the provider online tool for participating providers. Verify member benefits and eligibility with the provider call center before providing services.

Unlisted CPT codes that require prior authorization: 81479, 81599, 84999
Use an Unlisted CPT (e.g., 81479, 81599, 84999) for tests without a specific CPT code and secure prior authorization before billing
Failure to obtain prior authorization for Unlisted genetic testing CPT codes may lead to claim denial; providers should not bill members for services determined to be not medically necessary or non-covered unless there is a prior written agreement
Verify member-specific benefits and eligibility with the provider call center; subscriber/employer agreement governs coverage

Ordering and Prior Authorization Requirements

Prior Authorization

Prior authorization required for BlueCHiP; recommended for Commercial

Prior authorization is required for BlueCHiP for Medicare and recommended for Commercial products; participating providers must obtain prior authorization via the online tool before ordering unlisted molecular/genetic assays.

Note

Ordering details not specified

No additional ordering details are specified in this portion of the policy.

Frequency and Use Limits

inv-21: Unlisted molecular/genetic assays (prior auth required per use)

Prior authorization requiredUnlisted molecular/genetic assays require prior authorization for BlueCHiP for Medicare and Commercial Products

Typical unlisted CPT codesExamples include 81479, 81599, 84999 for tests without a specific CPT code

Use per-test authorizationPrior authorization is required per use of an unlisted molecular/genetic assay

Clinical Background

Cutaneous melanoma comprises the majority of melanoma cases. Diagnosis and triage begin with clinical and visual examination (including ABCDE and 'ugly duckling' criteria) and rely on histopathologic assessment of excised lesions; there is a low threshold for excisional biopsy when concern exists. Although gene expression profiling measures activity of multiple genes and has been proposed to aid biopsy decisions, clarify indeterminate histopathology, or inform sentinel lymph node biopsy (SLNB) decisions in AJCC stage I–II disease, current evidence is insufficient to establish that these tests improve patient outcomes.

Definitions and Test Descriptions

inv-17: Definition — Gene expression profiling explanation

DefinitionGene expression profiling measures the activity of thousands of genes simultaneously to create a snapshot of cellular function

TechnologiesIncludes methods such as DNA microarrays and RNA-Seq to generate gene expression data

Clinical applicationsUsed for disease diagnosis, classification, prediction of drug response, and prognosis

inv-18: Definition — SLNB and AJCC staging relevance

DefinitionSentinel lymph node biopsy (SLNB) is used to assess regional lymph node status

AJCC staging relevanceAJCC stage I–II are node-negative primary melanomas where SLNB or surveillance decisions may be influenced by prognostic tests