CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Optical Diagnostic Devices for Evaluating Skin Lesions Suspected of Malignancy

Policy governs coverage and medical necessity determinations for dermatoscopy (including digital/computer-assisted dermatoscopy) and computer-based optical imaging devices used to evaluate or serially monitor pigmented skin lesions for malignancy for BCBSRI members.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyOptical Diagnostic Devices for Evaluating Skin Lesions Suspected of Malignancy

Policy CodePolicy N/A

Change TypeNo material change

Effective Date06|01|2023

Next Review DateN/A

Key ActionDo not bill dermatoscopy or computer-based optical imaging for evaluation or serial monitoring of pigmented skin lesions without verifying member-specific coverage, as these services are not covered or are not medically necessary.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Not covered / Not medically necessaryCoverage stance

96904Not covered CPT

96999Use unlisted code

FDA-mentionedDevice status

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Not Covered / Not Medically Necessary Services

Medicare Advantage - Not Covered: Dermatoscopy (direct inspection, digitization of images, or computer-assisted analysis) and computer-based optical imaging devices (eg, multispectral digital skin lesion analysis) for evaluating or serially monitoring pigmented skin lesions are not covered because evidence is insufficient to determine effects on health outcomes.

Also not covered for defining peripheral margins prior to surgical excision; limited photography for documentation is considered part of the medical record and is not separately reimbursed.

Commercial Products - Not Medically Necessary: Dermatoscopy (direct inspection, digitization of images, or computer-assisted analysis) and computer-based optical imaging devices (eg, multispectral digital skin lesion analysis) for evaluating or serially monitoring pigmented skin lesions are considered not medically necessary because evidence is insufficient to determine effects on health outcomes.

Also considered not medically necessary for defining peripheral margins prior to surgical excision; limited photography for documentation is considered part of the medical record and is not separately reimbursed.

Dermatoscopy and computer-based optical imaging devices are not covered for the purpose of defining peripheral margins of skin lesions suspected of malignancy prior to surgical excision. Limited photography for documentation in the medical record is considered part of charting and is not separately reimbursed.

For Commercial Products, dermatoscopy (including direct inspection, digitization of images, or computer-assisted analysis) and computer-based optical imaging devices (for example, multispectral digital skin lesion analysis) are considered not medically necessary for evaluating or serially monitoring pigmented skin lesions because the evidence is insufficient to determine effects on health outcomes. Limited photography for documentation is part of the medical record and is not separately reimbursed.

Provider Actions, Documentation & Billing Guidance

Prior Authorization

Prior authorization / Verify benefits

Prior authorization is not applicable for these services. Benefit coverage may vary by contract; verify member-specific benefits, limitations, and medical necessity by referring to the member’s Benefit Booklet, Evidence of Coverage, or Subscriber Agreement before rendering services.

Verify benefits and contract-specific coverage prior to scheduling or billing

Denial Risk

Coverage status — dermatoscopy & computer-based optical imaging

Dermatoscopy and computer-based optical imaging are considered not covered or not medically necessary for evaluation or serial monitoring of pigmented skin lesions and for defining peripheral margins prior to excision. For Medicare Advantage and Commercial Products these services are not covered/not medically necessary as described in the policy.

Dermatoscopy (direct inspection, digitization, or computer-assisted analysis) — not covered / not medically necessary
Computer-based optical imaging (eg, multispectral digital skin lesion analysis) — not covered / not medically necessary
Dermatoscopy for defining peripheral margins prior to surgical excision — not covered / not medically necessary

Documentation Required

Clinical documentation & photography guidance

Document the clinical rationale for any imaging or monitoring decision. Record lesion characteristics (size, color, asymmetry, borders, evolution), clinical impression, and the reason for choosing observation versus biopsy. Limited photographic images captured solely for documentation are part of the medical record and are not separately reimbursable.

Document lesion location and measurable characteristics (eg, size in mm)
Record clinical assessment and decision-making (observation vs biopsy)
Include limited clinical photography in the record for documentation only — do not bill separately

Denial Risk

Billing & denial risk for 96904 and unlisted imaging

CPT 96904 (Whole body integumentary photography) is not covered for Medicare Advantage Plans and is not medically necessary for Commercial Products when used for monitoring high-risk patients as described. There is no specific CPT for computer-based optical imaging; submit claims for those services with CPT 96999 (Unlisted special dermatological service or procedure) when applicable. Limited clinical photography is considered part of the medical record and not separately reimbursed.

96904 — Whole body integumentary photography: not covered for Medicare Advantage; not medically necessary for Commercial Products when used for serial monitoring
96999 — Use for claims related to computer-based optical imaging (unlisted dermatological procedure)
Limited photography for documentation is not separately reimbursed

Background

Dermatoscopy (also called dermoscopy, epiluminescence microscopy, or in vivo cutaneous microscopy) and computer-based optical imaging are noninvasive techniques intended to improve distinction between benign and malignant pigmented skin lesions. Dermatoscopy uses immersion techniques and magnification to visualize epidermal and junctional structures and images may be digitized or analyzed by computer-assisted methods. Computer-based devices (eg, multispectral digital skin lesion analysis) analyze light–tissue interactions with proprietary algorithms to classify lesions and support decisions about biopsy or observation.

Definitions

Dermatoscopy — definition and image digitization/storage notes

DefinitionDermatoscopy (dermoscopy, epiluminescence microscopy, in vivo cutaneous microscopy) — noninvasive in vivo microscopic examination of pigmented skin lesions using immersion oil and magnification to visualize epidermal and epidermal–dermal junction structures.

Image digitizationImages (surface or dermatoscopic) may be digitized after initial visual assessment to permit storage, retrieval, comparator review over time, and qualitative image enhancement for improved visualization or computer-assisted analysis.

Technique and equipmentTechnique involves application of immersion oil to eliminate surface reflection and use of a magnifying lens or handheld/stereomicroscope for direct visual examination.

Clinical features assessedDermatoscopic features suggestive of malignancy include pseudopods, radial streaming, pigment network patterns, black dots, and assessment of asymmetry, borders, and color; multiple structured algorithms (eg, ABCD, 3-point/7-point checklists, Menzies, CASH) are used.

UsesProposed uses include distinguishing benign from malignant pigmented lesions, serial monitoring of lesions over time, and defining peripheral margins prior to surgical excision (though policy excludes coverage for margin definition).

Computer-based multispectral digital skin lesion analysis — device and algorithm

Device descriptionFDA-approved multispectral digital skin lesion analysis device: a handheld scanner that illuminates suspicious lesions with multiple visible wavelengths (10 wavelengths ranging approximately from 430 nm to 950 nm).

Optical penetrationEmitted light penetrates up to approximately 2.5 mm beneath the skin surface.

Data processing and algorithmScanner-acquired data are analyzed by a data processor using proprietary computer algorithms that evaluate lesion characteristics and classify lesions as positive (high morphologic disorganization) or negative (low morphologic disorganization).

Intended useIntended for assessment of suspicious pigmented lesions on intact skin and for use only by trained dermatologists; positive classifications are recommended for biopsy while negative results require consideration of other clinical factors.

Regulatory status noteDevice referenced in the policy is FDA-approved (see Regulatory Status section for details).

OpenPayer

Optical Diagnostic Devices for Evaluating Skin Lesions Suspected of Malignancy

Coverage Criteria and Exclusions

Coding and Billing

Provider Actions, Documentation & Billing Guidance

Background

Definitions