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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.
No material clinical or coverage changes in this revision.
Coverage Criteria
Experimental/Investigational - Not medically necessary
Not covered because the device is experimental and investigational
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
Adjunctive alert only; not established as diagnostic.
Coding and Technical Parameters
| 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. |
Provider Actions and 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
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
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 — 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
Definitions
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.
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