CurrentAetnaPolicy 0337

BreastCare/BreastAlert Differential Temperature Sensor

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Defines Aetna's coverage stance for the BreastCare/BreastAlert differential temperature sensor device used to detect heat-emitting breast disease; applies to requests for use of this device in clinical practice for Aetna members and their providers.

Policy Summary

PayerAetna

PolicyBreastCare/BreastAlert Differential Temperature Sensor

Policy CodePolicy 0337

Change TypeNo material changes

Effective DateJun 29, 1999

Last ReviewMay 30, 2023

Next Review DateMar 28, 2024

Key ActionDo not authorize use of the BreastCare/BreastAlert device without justification because it is considered experimental and investigational.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

experimentalcoverage stance

2°Falert threshold

15 min

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CurrentAetnaPolicy 0337

BreastCare/BreastAlert Differential Temperature Sensor

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Policy Summary

PayerAetna

PolicyBreastCare/BreastAlert Differential Temperature Sensor

Policy CodePolicy 0337

Change TypeNo material changes

Effective DateJun 29, 1999

Last ReviewMay 30, 2023

Next Review DateMar 28, 2024

Key ActionDo not authorize use of the BreastCare/BreastAlert device without justification because it is considered experimental and investigational.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

experimentalcoverage stance

2°Falert threshold

15 min

Coverage Criteria

Experimental/Investigational - Not medically necessary

Not covered because the device is experimental and investigational

Primary rationale: The BreastCare/BreastAlert differential temperature sensor is considered experimental and investigational because there is insufficient scientific evidence in the medical literature to support its routine use in clinical practice and the effectiveness of this device has not been established.

This policy applies to the BreastCare/BreastAlert differential temperature sensor (also referenced as the BreastCare DTS or BreastAlert Differential Temperature Sensor). The device is intended to detect areas of increased skin temperature over the breasts by recording temperatures on three large segments of each breast while the patient wears adhesive pads for about 15 minutes in the office. The device flags an averaged temperature differential of ≥ 2°F between mirror-image segments as an alert to the clinician of possible heat‑emitting, medically significant breast disease that may warrant further diagnostic evaluation.

Aetna considers use of the BreastCare/BreastAlert differential temperature sensor experimental and investigational because there is insufficient scientific evidence demonstrating acceptable sensitivity and specificity for detecting thermally active breast disease. The policy states the device’s clinical utility compared with standard breast cancer screening methods has not been established, and well‑designed studies are needed to determine diagnostic accuracy and impact on patient outcomes.

thermographic alert for possible heat-emitting breast disease

Device alert criteria: An averaged temperature differential of 2 degrees Fahrenheit or more between mirror-image segments alerts the physician to possible underlying breast disease in need of further examination.>= 2°F

Adjunctive alert only; not established as diagnostic.

Coding and Technical Parameters

Other CPT/ICD codes mentionedmixed

77066	Diagnostic mammography, including computer-aided detection (CAD) when performed; bilateral.
77067	Screening mammography, bilateral (2-view study of each breast), including computer-aided detection (CAD) when performed.
C50.011 - C50.919	Malignant neoplasm of female breast (range listed in policy).
C79.81	Secondary malignant neoplasm of breast.
D05.00 - D05.92	Carcinoma in situ of breast.
D24.1 - D24.9	Benign neoplasm of breast.
N60.01 - N64.89	Other disorders of breast.
T85.44x+	Capsular contracture of breast implant.

inv-05: temperature differential alert — numeric alert threshold

Temperature differential alert>= 2 degrees Fahrenheit

Purpose of thresholdAlerts physician to possible underlying breast disease between mirror-image segments

How calculatedAveraged temperature differential between mirror-image segments of the breasts

inv-06: in-office wear time — typical device wear duration

Typical in‑office wear time15 minutes (worn inside the bra while at the doctor's office)

Wear locationInside the bra using a pair of soft, lightweight pads

Provider Actions and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for requests to use the BreastCare/BreastAlert Differential Temperature Sensor. Because the device is considered experimental and investigational, claims for its use are subject to denial unless prior authorization documentation justifies medical necessity.

Affected policy: Aetna Policy 0337
Device: BreastCare/BreastAlert Differential Temperature Sensor (BreastAlert, BreastCare, BreastCare DTS)
Prior authorization implication: requests may be denied as experimental/investigational

Documentation Required

Device Documentation

Use clear, contemporaneous documentation in the medical record that supports the clinical rationale for use. Include the indication for testing, prior and concurrent breast cancer screening results (eg, mammography, clinical breast exam), and any signs or symptoms that prompted consideration of the device.

Definitions

inv-12: device description — BreasAlert Differential Temperature Sensor name/identifier

Device nameBreastAlert Differential Temperature Sensor (Scantek Medical, Inc.)

Device typePair of soft, lightweight adhesive pads placed on the breasts (liquid crystal sheet method)

FunctionRecords skin temperatures on three large segments of each breast to detect averaged temperature differentials

Regulatory noteEvaluated by the FDA for indicating the possibility of heat-emitting breast disease

Background

Thermography measures surface temperature variations using infrared imaging or topical temperature sensors to produce a physiologic map of skin temperature; areas of increased metabolic activity such as tumors may generate localized heat and increased blood flow. The BreastAlert device uses soft pads worn inside the bra to record temperatures on three segments of each breast during an approximately 15-minute in‑office wear time and reports an averaged inter‑breast differential of ≥ 2°F between mirror‑image segments as an alert for possible underlying disease.

Not Covered / Exclusions

Use of the BreastCare/BreastAlert differential temperature sensor for screening or diagnostic detection of breast cancer is not covered because the device is considered experimental and investigational and its effectiveness has not been established.