BreastCare/BreastAlert Differential Temperature Sensor

Number: 0337

Table Of Contents

Policy
Applicable CPT / HCPCS / ICD-10 Codes
Background
References

Policy

Scope of Policy

This Clinical Policy Bulletin addresses BreastCare/BreastAlert differential temperature sensor.

  1. Experimental, Investigational, or Unproven

    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, is considered experimental, investigational, or unproven 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.

  2. Related Policies

Table:

CPT Codes / HCPCS Codes/ ICD-10 Codes

Code Code Description

Information in the [brackets] below has been added for clarification purposes.   Codes requiring a 7th character are represented by "+":

BreastAlert Differential Temperature Sensor device:
No specific code

Other CPT codes related to the CPB:
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

ICD-10 codes not covered for indications listed in the CPB (not all-inclusive):
C50.011 - C50.019
C50.111 - C50.119
C50.211 - C50.219
C50.311 - C50.319
C50.411 - C50.419
C50.511 - C50.519
C50.611 - C50.619
C50.811 - C50.819
C50.911 - C50.919		 Malignant neoplasm of female breast
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

Background

Thermography is a diagnostic technique in which an infrared camera (also called digital infrared thermal imaging) is used to measure temperature variations on the surface of the body, producing images that reveal sites of abnormal tissue growth. Tumors may exhibit higher metabolic activity (manifested in heat and increased blood flow) and the increase in body temperature is suggested to be used to screen and diagnose breast abnormalities. An alternate method of thermography involves the placement of liquid crystal sheets directly onto the skin (eg, BreastCare/BreastAlert Differential Temperature Sensor). 

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.

Hoeg and associates (2021) noted that patient-reported outcomes (PRO) may facilitate prompt treatment.  These researchers described the development and psychometric properties of the 1st instrument to monitor for symptoms of breast cancer (BC) recurrence.  This study was nested in the MyHealth randomized trial of nurse-led follow-up based on electronically-collected PROs.  These investigators constructed items evaluating symptoms of potential recurrence via expert interviews with 6 BC specialists in Denmark.  Semi-structured cognitive interviews were performed with a patient panel to examine acceptability and comprehensibility.  Items were subsequently tested in a population of 1,170 women 1 to 10 years after completing BC treatment.  These researchers conducted multiple-groups confirmatory factor analysis (CFA) and Rasch analysis to test dimensionality, local dependence (LD) and differential item functioning (DIF) according to socio-demographic and treatment-related factors.  Clinical data were obtained from the Danish Breast Cancer Group registry.  A total of 21 items were generated for the Breast Cancer Recurrence instrument (BreastCaRe).  Cognitive testing resulted in clearer items; 7 subscales based on general, bone, liver, lung, brain, loco-regional and contralateral recurrence symptoms were proposed.  Both CFA and Rasch models confirmed the factor structure.  No DIF was identified; 5-item pairs showed LD; but all items were retained to avoid loss of clinical information.  Rasch models taking LD into account were used to generate a standardized scoring table for each subscale.  The authors concluded that the BreastCaRe had good content and structural validity, patient acceptability and measurement invariance.  These researchers are preparing to examine the predictive validity of this new instrument.

References

The above policy is based on the following references:

  1. Alberta Heritage Foundation for Medical Research (AHFMR), Health Technology Assessment Unit. BreastCare®/ BreastAlert®. TechScan. Health Technology Assessment Publications. Edmonton, AB: AHFMR; July 2000.
  2. 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.
  3. Barros A, Ronco A, Nisida AC, et al. Diagnostic efficiency of Breastcare: A Brazilian multicenter clinical study. Rev Bras Mastol. 1999;9:62-67.
  4. Hoeg BL, Saltbæk L, Christensen KB, et al. The development and initial validation of the Breast Cancer Recurrence instrument (BreastCaRe) -- a patient-reported outcome measure for detecting symptoms of recurrence after breast cancer. Qual Life Res. 2021 Sep;30(9):2671-2682.
  5. 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.
  6. Ozanne E, Karliner LS, Tice JA, et al. An intervention tool to increase patient-physician discussion of lifestyle risk factors for breast cancer. J Womens Health (Larchmt). 2019;28(11):1468-1475.
  7. Randal J. Heat-seeking pads may help find early breast cancers. J Natl Cancer Inst. 1997;89(19):1402-1404.
  8. 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.
  9. 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.
  10. 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.
  11. 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.