CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Medical Coverage Policy Reflectance Confocal Microscopy for Evaluating Skin Lesions for Suspected Malignancy

Defines Blue Cross Blue Shield Rhode Island coverage position for reflectance confocal microscopy (RCM/CSLM) used to evaluate or serially monitor pigmented skin lesions for suspected malignancy, and lists applicable CPT codes and coding coverage decisions for Medicare and Commercial products.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyMedical Coverage Policy Reflectance Confocal Microscopy for Evaluating Skin Lesions for Suspected Malignancy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 1, 2016

Next Review Date

Key ActionDo not bill members for RCM services that are not covered unless there is prior written agreement that the member will pay.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes noted in this update.

1Primary covered CPT listed (but policy states not covered)

5CPT codes designated not covered / not medically necessary

Coverage Summary

Defines Blue Cross Blue Shield Rhode Island coverage position for reflectance confocal microscopy (RCM/CSLM) used to evaluate or serially monitor pigmented skin lesions for suspected malignancy. Policy effective 2016-01-01, last reviewed 2018-11-20.

Coverage stance: Reflectance confocal microscopy is considered not covered / not medically necessary for evaluation or serial monitoring of pigmented skin lesions when used to detect suspected malignancy because evidence is insufficient to determine effects on health outcomes.

Published diagnostic accuracy studies and pooled analyses report high sensitivity and variable specificity for RCM: pooled sensitivity ranges approximately 90.74%–97.5% (meta-analysis ~93%), pooled specificity ranges approximately 83%–99% (meta-analysis ~76%); reported PPV 70.6%–97.5% and NPV 98.17%–99%.

Technology assessments (AHRQ, Hayes) concluded there is insufficient evidence to support routine use of noninvasive devices including confocal microscopy for improving patient outcomes or establishing selection criteria; available studies are mainly case series and diagnostic accuracy studies with limitations in design and applicability.

Coverage Determination / Medical Necessity

Coverage Determination

Reflectance confocal microscopy is considered not covered / not medically necessary for evaluation or serial monitoring of pigmented skin lesions when used to detect suspected malignancy because evidence is insufficient to determine effects on health outcomes.

ALL of the following

Technique: Reflectance confocal microscopy (RCM) or confocal scanning laser microscopy (CSLM)
Indication: To evaluate or serially monitor pigmented skin lesions for suspected melanoma or other malignancy
Coverage decision: Considered not covered for BlueCHiP for Medicare and considered not medically necessary for Commercial products due to insufficient evidence of clinical utility

CPT Codes and Coding Decisions

Covered CPTCPTNot Covered

96931

Reflectance confocal microscopy (RCM) for cellular and sub-cellular imaging of skin; image acquisition and interpretation and report; first lesion

Not Covered / Not Medically Necessary CPTCPTNot Covered

96932	Reflectance confocal microscopy (RCM) for cellular and sub-cellular imaging of skin; image acquisition only, first lesion
96934	Reflectance confocal microscopy (RCM) for cellular and sub-cellular imaging of skin; image acquisition and interpretation and report; each additional lesion (List separately in addition to code for primary procedure)
96933	Reflectance confocal microscopy (RCM) for cellular and sub-cellular imaging of skin; interpretation and report only, first lesion
96935	Reflectance confocal microscopy (RCM) for cellular and sub-cellular imaging of skin; image acquisition only, each additional lesion (List separately in addition to code for primary procedure)
96936	Reflectance confocal microscopy (RCM) for cellular and sub-cellular imaging of skin; interpretation and report only, each additional lesion (List separately in addition to code for primary procedure)

Provider Actions & Billing Guidance

Documentation Required

Do not bill as separate when part of dermoscopy

Dermoscopy is considered part of the normal evaluation of a pigmented skin lesion and is not reimbursed as a separate examination; providers should refer to benefit booklet/subscriber agreement for member-specific coverage.

Dermoscopy is part of standard evaluation and not separately reimbursed.

Billing Rule

Claims for RCM considered not covered

Claims for RCM CPT codes listed as not covered / not medically necessary may be denied; providers should not bill members unless prior written agreement exists that member will pay for non-covered services.

Affected codes: 96931, 96932, 96933, 96934, 96935, 96936
Do not bill members for these non-covered services unless there is a prior written agreement that the member will pay.

Background and Definitions

Reflectance confocal microscopy (RCM/CSLM) is a noninvasive en face imaging technique that acquires cellular-level images of the epidermis and superficial dermis to assist evaluation of melanocytic and nonmelanocytic lesions. It is proposed as an adjunct to clinical examination and dermoscopy to help determine whether a lesion is benign or malignant.

Limitations include shallow imaging depth (confined to epidermis and papillary dermis) which can cause false negatives, reduced penetration with hyperkeratosis or surface materials, operator dependence and the need for training to interpret images. Published studies are primarily case series and diagnostic accuracy studies with variable sensitivity and specificity, and it remains uncertain whether RCM improves clinical outcomes such as earlier diagnosis or reduced missed melanomas.

Reflectance confocal microscopy (RCM): Noninvasive imaging technique (also confocal scanning laser microscopy, CSLM) using a near-infrared laser (e.g., 830 nm) to acquire en face cellular-level images of the epidermis and superficial dermis to assist clinical judgment.

Evidence Summary

Evidence summary

Reported diagnostic accuracy (pooled ranges)Sensitivity 90.74%–97.5%; Specificity 83%–99%; PPV 70.6%–97.5%; NPV 98.17%–99%; meta-analysis sensitivity ~93%, specificity ~76%

AHRQ / Hayes assessmentsConcluded insufficient evidence to support routine use of noninvasive devices including confocal microscopy for improving patient outcomes or establishing selection criteria