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Clinical Policy Bulletin:
BreastCare/BreastAlert Differential Temperature Sensor
Number: 0337


Policy

Aetna considers the BreastCare DTS™ device (Life Medical Technologies, Fishkill, NY), previously known as BreastAlert Differential Temperature Sensor device (HumaScan, Inc., Cranford, NJ), which has been used to detect cancer and other heat-emitting medically significant breast disease, experimental and investigational because there is insufficient scientific evidence in the medical literature to support its routine use in clinical practice.

See also CPB 0029 - Thermography, CPB 0105 - Magnetic Resonance Imaging (MRI) of the Breast, CPB 0227 - BRCA Testing, Prophylactic Mastectomy and Prophylactic Oophorectomy, CPB 0269 - Breast Biopsy Procedures, CPB 0352 - Tumor Markers, CPB 0386 - Breast Transillumination, Electrical Impedance Scanning (EIS), and Elastography, and CPB 0584 - Mammography.



Background

Based on the evaluation of initial clinical data, the Food and Drug Administration has approved the BreastAlert Differential Temperature Sensor (Scantek Medical, Inc., Denville, NJ) for indicating the possibility of heat-emitting, medically significant breast disease, including cancer.  The BreastAlert device consists of a pair of soft, lightweight pads that a woman wears inside her bra for 15 minutes while at the doctor's office as an adjunct to standard breast cancer screening.  They record skin temperatures on 3 large segments of each breast.  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.

As with thermography, there is a lack of evidence in the medical literature demonstrating an acceptable level of sensitivity and specificity in using the BreastAlert differential temperature sensor device as a physiologic imaging method for detecting a possible thermally active cancer.  The clinical utility of this technique has not been compared to other readily available methods to screen for breast cancer.  Well-designed clinical studies are needed to ascertain the diagnostic accuracy and clinical usefulness of the BreastAlert differential temperature sensor device.
 
CPT Codes / HCPCS Codes/ ICD-9 Codes
There are no specific codes for the BreastAlert Differential Temperature Sensor device:
Other CPT codes related to the CPB:
77055
77056
77057
ICD-9 codes not covered for indications listed in the CPB (not all-inclusive):
174.0 - 174.9 Malignant neoplasm of female breast
198.81 Secondary malignant neoplasm of the breast
217 Benign neoplasm of breast
233.0 Carcinoma in situ of breast
610.0 - 611.9 Disorder of breast


The above policy is based on the following references:
  1. Randal J. Heat-seeking pads may help find early breast cancers. J Natl Cancer Inst. 1997;89(19):1402-1404.
  2. Simpson HW, McArdle C, Pauson AW, et al. A non-invasive test for the pre-cancerous breast. Eur J Cancer. 1995;31A(11):1768-1772.
  3. Simpson HW. A breast pre-cancer test? Preliminary results based on a breast temperature rhythm abnormality during the menstrual cycle. Breast Cancer Res Treat. 1990;16(1):51-55.
  4. Barros A, Ronco A, Nisida AC, et al. Diagnostic efficiency of Breastcare: A Brazilian multicenter clinical study. Rev Bras Mastol. 1999;9:62-67.
  5. Alberta Heritage Foundation for Medical Research (AHFMR), Health Technology Assessment Unit. BreastCare®/ BreastAlert®. TechScan. Health Technology Assessment Publications. Edmonton, AB: AHFMR; July 2000. Available at: http://www.ahfmr.ab.ca/hta/hta-publications/techscans/scantek-21-00.shtml. Accessed October 17, 2002.
  6. Ng EY, Sudharsan NM. Computer simulation in conjunction with medical thermography as an adjunct tool for early detection of breast cancer. BMC Cancer. 2004;4(1):17.
  7. Warning Letter from Deborah Wolf, Regulatory Counsel, Center for Devices and Radiological Health, Food and Drug Adminstration, Rockville, MD to Donald Brounstein, President and Chief Executive Officer, HumaScan, Inc., Cranford, NJ, regarding misbranding of BreastAlert Differential Temperature Sensor, April 24, 1998. Available at: www.fda.gov/foi/warning_letters/d1713b.pdf. Accessed May 13, 2005.
  8. American Cancer Society (ACS). Buyer beware. Devices for breast self exam under scrutiny. ACS News Center. Atlanta, GA: ACS; July 28, 1998. Available at: http://www.cancer.org/docroot/NWS/content/NWS_1_1x_Buyer_Beware.asp. Accessed May 13, 2005.
  9. U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH). Breast Alert Breast Thermal Activity Indicator. Device Listing Database. CDRH SuperSearch. Rockville, MD: FDA; July 13, 2004. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/search/search.cfm?db=LST&ID=48872. Accessed May 13, 2005.


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Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
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