Blue Cross Blue Shield RI gene expression profiling Coverage | OpenPayer

Loading...

Blue Cross Blue Shield RI gene expression profiling Coverage | OpenPayer

Coverage Criteria

BlueCHiP for Medicare - Not covered indications

Covered when ALL of the following are met:

Medicare - Suspicious pigmented lesions: Gene expression testing in the evaluation of patients with suspicious pigmented lesions is not covered

evidence insufficient to determine the effects of the technology on health outcomes

Medicare - Indeterminate histopathology: Gene expression testing in the evaluation of melanocytic lesions with indeterminate histopathologic features is not covered

evidence insufficient to determine the effects of the technology on health outcomes

Medicare - Cutaneous melanoma: Gene expression testing in the evaluation of patients with cutaneous melanoma is not covered for all indications

evidence insufficient to determine the effects of the technology on health outcomes

Commercial Products - Not medically necessary indications

Covered when ALL of the following are met:

Commercial - Suspicious pigmented lesions: Gene expression testing in the evaluation of patients with suspicious pigmented lesions is considered not medically necessary

evidence insufficient to determine the effects of the technology on health outcomes

Commercial - Indeterminate histopathology: Gene expression testing in the evaluation of melanocytic lesions with indeterminate histopathologic features is considered not medically necessary

evidence insufficient to determine the effects of the technology on health outcomes

Commercial - Cutaneous melanoma: Gene expression testing in the evaluation of patients with cutaneous melanoma is considered not medically necessary for all indications

evidence insufficient to determine the effects of the technology on health outcomes

Benefits for gene expression testing and other services may vary by contract. Refer to the member's contract-specific Benefit Booklet, Evidence of Coverage, or Subscriber Agreement to determine whether a given service is a not medically necessary or not covered benefit for that member.

This medical policy is provided for informational purposes only and is not a guarantee of payment. Coverage and payment decisions are determined by the member's subscriber agreement, member certificate, and/or employer agreement, which supersede this policy.

For Commercial Products, gene expression testing for suspicious pigmented lesions, melanocytic lesions with indeterminate histopathologic features, and cutaneous melanoma is considered not medically necessary because the evidence is insufficient to determine effects on health outcomes.

Clinical Indications Discussed

Evaluation of suspicious pigmented lesions for biopsy decision; adjunct to histopathology for indeterminate melanocytic lesions; prognostic evaluation to guide SLNB or surveillance in AJCC stage I–II melanoma.

These clinical applications are described in the literature but, per this policy, are not supported for coverage due to insufficient evidence:

Evaluation for biopsy decision: Use of gene expression profiling to evaluate suspicious pigmented lesions (eg, to determine which lesions should proceed to skin biopsy) is described but is considered unsupported by sufficient evidence

evidence derives from observational studies with methodologic limitations and no demonstrated clinical utility

Adjunct to histopathology for indeterminate lesions: Use of gene expression profiling as an adjunct to histopathology for melanocytic lesions with indeterminate histopathologic features (to aid diagnosis) is described but is considered unsupported by sufficient evidence

clinical validity not well-characterized; no direct evidence of clinical utility

Prognostic evaluation to guide management in AJCC I–II melanoma:

Not Covered / Not Medically Necessary

Gene expression tests including the DermTech Pigmented Lesion Assay, myPath Melanoma, and DecisionDx-Melanoma are not covered or considered not medically necessary for the indicated clinical uses (evaluation of suspicious pigmented lesions to guide biopsy, adjunctive diagnosis of indeterminate melanocytic lesions, and prognostic assessment to guide SLNB or surveillance in AJCC stage I–II melanoma) because the evidence is insufficient to demonstrate test performance and clinical utility.

Coverage for these tests is ultimately determined by the member's benefit documents. This policy does not provide an explicit coverage guarantee; providers should verify member-specific benefits and eligibility prior to ordering or billing these services.

Billing and Coding

Billing / Unlisted CPT codes and related codesCPT

81479	Unlisted molecular pathology procedure
81599	Unlisted multianalyte assay with algorithmic analysis
84999	Unlisted chemistry procedure
81401	CPT code noted as representing only 2 genes (not representative of listed panel tests)

Diameter threshold in ABCDE — clinical key/value (>= 6 mm)

ABCDE diameter threshold>= 6 mm

ABCDE checklist itemsAsymmetry; Border irregularities; Color variegation; Diameter; Evolution

Clinical useDiameter >=6 mm is a visual feature suggestive of melanoma prompting consideration of biopsy or dermatology referral

Provider Actions, Prior Authorization & Billing Notes

Prior Authorization

Prior Authorization Required

Prior authorization requirements vary by product. For BlueCHiP for Medicare, prior authorization is required for all unlisted genetic testing CPT codes to determine the specific service and whether it is covered or medically necessary. For Commercial Products, prior authorization is recommended. Participating providers should obtain authorization via the insurer's online tool.

Prior authorization required for BlueCHiP for Medicare (all unlisted genetic testing CPT codes).
Prior authorization recommended for Commercial Products.
Authorization obtained via the online tool for participating providers.

Documentation Required

Filing and Prior Authorization Documentation

There are no specific CPT codes for the panel tests covered by this policy. Providers must file using an appropriate unlisted CPT code; failure to use an unlisted code or to obtain required prior authorization may result in claim denial.

Ordering & Prior Authorization

Step Therapy

Obtain prior authorization via online tool for ordering

Prior authorization is required for BlueCHiP for Medicare and recommended for Commercial products. Participating providers must obtain prior authorization via the online tool.

Definitions

Gene expression profiling definition — measures activity of many genes (microarrays, RNA-Seq)

DefinitionMeasures the activity of thousands of genes simultaneously to create a snapshot of cellular function

TechnologiesData generated by DNA microarrays and RNA-Seq

Clinical applicationsUsed for diagnosis, disease classification, predicting drug response, and prognosis

SLNB — Sentinel lymph node biopsy definition

DefinitionSentinel lymph node biopsy (SLNB) is a procedure to evaluate regional lymph node status to guide staging and management in melanoma

PurposeProvides more definitive information about regional node involvement to inform prognosis and treatment decisions

Background

Gene expression profiling assays measure the activity of multiple genes simultaneously (eg, via microarray or RNA‑Seq) to produce a molecular profile that may be used for diagnosis, classification, or prognostication. These assays have been developed to assist clinical decisions such as whether to biopsy a suspicious pigmented lesion, to supplement histopathology when melanocytic lesions are indeterminate, or to risk‑stratify patients with AJCC stage I–II cutaneous melanoma to guide sentinel lymph node biopsy or surveillance. The evidence cited in the literature is observational and, as summarized in this policy, is insufficient to establish test performance or clinical utility for these indications.

Frequency Limits

Frequency limits placeholder (no label provided in inventory)

Frequency limitsNo specific frequency limits stated in this policy

Policy stancePolicy is informational; coverage and any frequency restrictions are determined by member-specific benefit documents

Action for providersContact provider call center or refer to the member's subscriber/employer agreement for applicable limits

Revision History

2018-10-01policy_effective

Policy effective date as shown in the brief metadata.

2019-02-05last_review

Policy last reviewed on this date per brief metadata.

2019-04provider_update_published

Provider update published relating to this policy (noted in brief statistics).