CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Optical Diagnostic Devices for Evaluating Skin Lesions Suspected of Malignancy

This policy defines Blue Cross Blue Shield - Rhode Island's coverage stance on dermatoscopy (including digitized and computer-assisted analysis) and multispectral digital skin lesion analysis (MSDSLA) for evaluating, monitoring, or defining margins of pigmented skin lesions suspected of malignancy, for Medicare (BlueCHiP) and Commercial products.

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 changes

Effective DateJun 1, 2009

Next Review DateN/A

Key ActionDo not bill multispectral digital skin lesion analysis or dermatoscopy services as covered — they are considered not covered/not medically necessary.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Not coveredDermatoscopy stance

Not coveredMSDSLA stance

PMA referencedMelaFind status

ListedCPT 96904

~25

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria

BlueCHiP for Medicare

Coverage stance summarized by product:

BlueCHiP for Medicare stance: Dermatoscopy (direct inspection, digitization, or computer-assisted analysis) is not covered to evaluate or serially monitor pigmented skin lesions; dermatoscopy is not covered for defining peripheral margins of lesions suspected of malignancy to surgical excision; MSDSLA is not covered for evaluating, serial monitoring, or defining peripheral margins of pigmented lesions.

Limited photography for documentation considered part of record and not separately reimbursed.

Commercial Products

Commercial Products stance: Dermatoscopy (direct inspection, digitization, or computer-assisted analysis) is considered not medically necessary to evaluate or serially monitor pigmented skin lesions and not medically necessary for defining peripheral margins of skin lesions suspected of malignancy; MSDSLA is considered not medically necessary in all situations including evaluating pigmented lesions, defining peripheral margins, and serial monitoring.

Limited photography for documentation considered part of record and not separately reimbursed.

MelaFind's FDA-approved intended use includes multiple lesion-level exclusions. The device is indicated only for lesions with a diameter between 2 mm and 22 mm, lesions that are accessible by the imager, and lesions that are sufficiently pigmented (i.e., not for nonpigmented or skin-colored lesions). It is not intended for lesions that contain scar or fibrosis consistent with prior trauma, lesions where the skin is not intact (for example, ulcerated or bleeding lesions), lesions located within 1 cm of the eye, lesions that contain foreign matter, or lesions on certain anatomic sites (specifically not for use on acral, palmar, plantar, mucosal, or subungual areas).

Coverage and benefit determinations are governed by the member's subscriber agreement, member certificate, and/or employer agreement, which supersede this medical policy. This policy is informational and does not guarantee payment; verify member-specific benefits and eligibility with the provider call center prior to delivering services.

Dermatoscopy (including direct inspection, digitized images, or computer-assisted analysis) and multispectral digital skin lesion analysis (MSDSLA) are identified in this policy as not covered / not medically necessary for evaluating pigmented skin lesions, for serial monitoring of pigmented lesions, and for defining peripheral margins of lesions suspected of malignancy, because the evidence is insufficient to determine their effects on health outcomes. Specific MSDSLA devices (eg, MelaFind) likewise lack sufficient evidence to support clinical utility in these situations.

If services are determined to be not medically necessary (or are medically necessary but are non‑covered benefits under the member's contract), the provider may not charge the member for those services unless the member was informed in advance and agreed to accept financial responsibility. Refer to your participation agreement(s) for applicable provisions regarding member charges and billing for non‑covered services.

Coding and Billing

Covered / descriptiveCPT

96904

Whole body integumentary photography, for monitoring of high risk patients with dysplastic nevus syndrome or a history of dysplastic nevi, or patients with a personal or familial history of melanoma

Not covered / Not medically necessaryCPTNot Covered

0400T	Multi-spectral digital skin lesion analysis of clinically atypical cutaneous pigmented lesions for detection of melanomas and high risk melanocytic atypia; one to five lesions
0401T	Multi-spectral digital skin lesion analysis of clinically atypical cutaneous pigmented lesions for detection of melanomas and high risk melanocytic atypia; Six Or more lesions

Provider Actions and Notices

Prior Authorization

Coverage / Prior Authorization

Prior authorization: Not applicable. Multispectral digital skin lesion analysis (MSDSLA; CPT 0400T, 0401T) and dermatoscopy (direct inspection, digitized images, or computer-assisted analysis) are not covered / are considered not medically necessary for evaluating, serially monitoring, or defining peripheral margins of pigmented skin lesions for surgical excision.

Not covered / Not medically necessary: CPT 0400T, 0401T (MSDSLA)
Dermatoscopy (all techniques) — not covered / not medically necessary for: evaluating pigmented lesions; serial monitoring of pigmented lesions; defining peripheral margins for surgical excision
Limited photography for documentation is considered part of the medical record and is not separately reimbursed (see CPT 96904 for whole body integumentary photography when applicable)

Note

Verify Member Benefits

Verify member benefits and eligibility prior to providing services. Contact the provider call center for member-specific benefit information and coverage determinations.

Background

Dermatoscopy refers to a family of noninvasive techniques that allow in vivo microscopic examination of pigmented skin lesions. By using magnification and methods such as dermoscopy or epiluminescence microscopy, clinicians can visualize epidermal and dermal‑epidermal structures to help distinguish benign from malignant pigmented lesions; however, despite its diagnostic role, this policy concludes dermatoscopy (including digitized or computer‑assisted variants) is not covered or is considered not medically necessary for the specified clinical uses due to insufficient evidence of improved health outcomes.

Definitions

Dermatoscopy definition — noninvasive techniques

DefinitionDermatoscopy is a family of noninvasive techniques (including dermoscopy, epiluminescence microscopy) that use immersion oil and magnification to visualize epidermal and dermal-epidermal structures to distinguish benign from malignant pigmented lesions.

Technique detailsTechnique involves application of immersion oil to eliminate surface reflection and use of a magnifying lens or handheld/stereomicroscope for in vivo microscopic examination of skin lesions.

Image handlingImages may be digitized (surface or dermatoscopic) for storage, comparison over time, qualitative enhancement, and possible computer-assisted diagnosis.

Clinical usesProposed uses include differentiation of benign versus malignant pigmented lesions, serial monitoring of lesions, and defining peripheral margins for surgical excision (though coverage policy denies these uses).

MSDSLA definition — multispectral noninvasive imaging

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 changes

Effective DateJun 1, 2009

Next Review DateN/A

Key ActionDo not bill multispectral digital skin lesion analysis or dermatoscopy services as covered — they are considered not covered/not medically necessary.

SourceLink

On This Page

Call the provider call center to confirm eligibility and benefits before scheduling or performing services
Member-specific benefits are governed by the subscriber agreement/member certificate and/or employer agreement

Note

Benefits Vary by Contract

Benefits and coverage vary by contract. Always refer to the member's Benefit Booklet, Evidence of Coverage, or Subscriber Agreement for applicable not medically necessary and coverage rules.

Benefits may differ between groups and contracts — check the applicable plan documents

Denial Risk

Denial Risks for MSDSLA and Dermatoscopy

Denial risk: Claims for MSDSLA (CPT 0400T, 0401T) and dermatoscopy-related services are subject to denial as not covered / not medically necessary. Submit documentation only when appropriate and expect denials for the listed services in non-covered indications.

Denied / Not medically necessary: CPT 0400T, 0401T
Dermatoscopy-related services for evaluation, serial monitoring, or margin definition are not medically necessary and may be denied

Billing Rule

Member Charges and Medical Necessity

Member charges: If a service is determined to be not medically necessary or is a non-covered benefit, you may not charge the member unless the member has been informed and has agreed in advance to accept financial responsibility. Refer to your participation agreement(s) for applicable provisions.

Do not bill members for services determined not medically necessary unless prior informed consent and agreement to self-pay is documented
Review participation agreement for charging rules

Documentation Required

Photography / Documentation

Documentation note: Limited photography for documentation is considered part of the medical record and is not separately reimbursed. CPT 96904 may be used to report whole body integumentary photography for monitoring high-risk patients when appropriate; whole body photography is a component of dermatoscopy but may be billed separately per CPT guidance.

Limited photography is part of record keeping — not separately reimbursed
CPT 96904 — Whole body integumentary photography (for monitoring high-risk patients)

Note

Provider Notice

General notice: This medical policy is informational and not a guarantee of payment. Benefits and eligibility are determined by the member's plan documents which supersede this policy. BCBSRI may revise this policy at any time.

Policy is informational — not a substitute for clinical judgment
Member's subscriber agreement/member certificate and employer agreement govern benefits

DefinitionMultispectral digital skin lesion analysis (MSDSLA) is a noninvasive imaging technique that uses multiple light wavelengths and proprietary algorithms to evaluate pigmented lesions and classify them as positive (recommended for biopsy) or negative.

Technical characteristicsUses a handheld scanner emitting ~10 wavelengths (approx. 430 nm to 950 nm) that can penetrate up to ~2.5 mm beneath the skin surface; data are analyzed by proprietary computer algorithms.

Intended outputLesions are classified by the algorithm as high-degree morphologic disorganization (positive) or low-degree (negative); positive results are recommended for biopsy while negative results are considered with other clinical factors.

User restrictionsFDA-approved systems are intended for use on suspicious pigmented lesions on intact skin and for use by trained dermatologists.

MelaFind / MSDSLA — FDA SSED and device performance

Device exampleMelaFind (MELA Sciences/Strata Skin Sciences) — an MSDSLA device cleared by FDA through the premarket approval (PMA) process in November 2011 for evaluation of suspicious pigmented lesions.

FDA SSED notesMelaFind intended use: lesions 2–22 mm diameter, sufficiently pigmented (not for nonpigmented/skin-colored lesions), accessible to the imager, on intact (nonulcerated/nonbleeding) skin, not within 1 cm of the eye, not containing foreign matter, and not on acral/palmar/plantar/mucosal/subungual sites.

Commercial statusManufacturer announced in 2017 that it would no longer support or commercialize the MelaFind device.

Supporting evidenceDevice performance and safety are referenced in the FDA Summary of Safety and Effectiveness Data (SSED) and related published device performance studies.