CurrentAetnaPolicy 0337

BreastCare/BreastAlert Differential Temperature Sensor

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

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 minwear time

0337policy id

05/30/2023last review

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.

Policy Summary

PayerAetna

PolicyBreastCare/BreastAlert Differential Temperature Sensor

Policy CodePolicy 0337

Change TypeNo material changes

Effective DateJun 29, 1999

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

On This Page

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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

Purpose of wear durationAllows recording of skin temperatures on three large segments of each breast

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.

Document comparison with other screening modalities and why alternative, established tests are insufficient
Include patient history and physical exam findings that suggest focal breast disease

Step Therapy

No Step Therapy Guidance Provided

No step therapy or sequencing requirements are provided in this policy. The device is described only as an adjunct to standard breast cancer screening, and there is insufficient evidence to support routine use or to define a stepwise pathway.

Providers should not expect to satisfy any defined step-therapy criteria; use is evaluated case-by-case
If prior testing (eg, mammography) is available, include those results in the authorization request

Denial Risk

Denial Risk — Experimental/Investigational

Requests for coverage will commonly trigger denials because the BreastCare/BreastAlert device is considered experimental and investigational. Be prepared to receive a denial and pursue appeal only if new, high-quality evidence is submitted that demonstrates diagnostic accuracy and clinical utility.

Expected denial trigger: policy classification as experimental/investigational
Appeal note: supply peer‑reviewed comparative studies showing sensitivity, specificity, and impact on clinical outcomes

OpenPayer

BreastCare/BreastAlert Differential Temperature Sensor

Coverage Criteria

Coding and Technical Parameters

Provider Actions and Authorization

Definitions

Background

Not Covered / Exclusions