Risk-Reducing Mastectomy

POLICY NUMBER

A.7.01.09

DESCRIPTION

Risk-reducing mastectomy is defined as the removal of the breast in the absence of malignant disease to reduce the risk of breast cancer occurrence.

Risk-reducing mastectomy may be considered in individuals thought to be at high-risk of developing breast cancer, either due to family history, presence of genetic variants (eg, BRCA1,BRCA2, PALB2), having received radiotherapy to the chest, or the presence of lesions associated with an increased cancer risk such as lobular carcinoma in situ. Therefore, bilateral risk-reducing mastectomy may be performed to eliminate the risk of cancer arising elsewhere; chemoprevention and close surveillance are alternative risk-reduction strategies. Risk-reducing mastectomies are typically bilateral, but can also describe a unilateral mastectomy in a patient who has previously undergone or is currently undergoing a mastectomy in the opposite breast for invasive cancer (ie, contralateral risk-reducing mastectomy). Use of contralateral risk-reducing mastectomy has increased in the United States. An analysis of data from the National Cancer Database found that the rate of contralateral risk-reducing mastectomy in individuals diagnosed with unilateral stage I, II, or III breast cancer increased from approximately 4% in 1998 to 9.4% in 2002. Another analysis of data from the National Cancer Database (N=765,487) found that individuals with unilateral stage I breast cancer commonly underwent contralateral risk-reducing mastectomy, with an increase between 2006 (6%) and 2016 (9%).

The appropriateness of a risk-reducing mastectomy is a complicated risk-benefit analysis that requires estimates of a patient's risk of breast cancer, typically based on the patient's family history of breast cancer and other factors. Several models are available to assess risk of breast cancer. The specific risk factors included in the models vary, but all incorporate characteristics related to age, reproductive history, and family history. Race should also be considered when assessing risk. According to an analysis of the Surveillance, Epidemiology, and End Results program (SEER) from 2000 to 2015 (N=459,916), the risk of invasive contralateral breast cancer was higher in Black (hazard ratio, 1.44; 95% confidence interval, 1.35 to 1.54) and Hispanic individuals (hazard ratio, 1.11; 95% confidence interval, 1.02 to 1.20) compared to White individuals. In addition to the patient's risk assessment, the choice of a risk-reducing mastectomy is based on patient tolerance for risk, consideration of changes to appearance and need for additional cosmetic surgery, and the risk-reduction offered by mastectomy versus other options.

Mastectomy is a surgical procedure and, as such, is not subject to regulation by the U.S. Food and Drug Administration.

See Germline Genetic Testing for Hereditary Breast/Ovarian Cancer Syndrome and Other High-Risk Cancers (BRCA1, BRCA2, PALB2) medical policy.

POLICY

Risk-reducing mastectomy may be considered medically necessary in individuals at high risk of breast cancer. (For definitions of risk levels, see Policy Guidelines).

Risk-reducing mastectomy is considered investigational for all other indications, including but not limited to contralateral risk-reducing mastectomy in individuals with breast cancer who do not meet high-risk criteria.

POLICY EXCEPTIONS

None

POLICY GUIDELINES

It is strongly recommended that all candidates for risk-reducing mastectomy undergo counseling regarding cancer risks from a health professional other than the operating surgeon skilled to assess cancer risk and to discuss various treatment options, including increased surveillance or chemoprevention with tamoxifen or raloxifene.

There is no standardized method for determining an individual's risk of breast cancer that incorporates all possible risk factors. There are validated risk prediction models, but they are based primarily on family history.

Some known individual risk factors confer a high risk by themselves. The following list includes factors known to indicate a high risk of breast cancer:

• Lobular carcinoma in situ,

• A known BRCA1 or BRCA2 variant,

• Another gene variant associated with high risk, eg, TP53 (Li-Fraumeni syndrome), PTEN (Cowden syndrome, Bannayan-Riley-Ruvalcaba syndrome), CDH1, STK11, and PALB2,

• Received radiotherapy to the chest between 10 and 30 years of age.

A number of other factors may increase the risk of breast cancer, but do not by themselves indicate high risk (generally considered to be a lifetime risk of ≥20%). It is possible that combinations of these factors may be indicative of high risk, but it is not possible to give quantitative estimates of risk. As a result, it may be necessary to individualize the estimate of risk by taking into account numerous risk factors. A number of risk factors, not individually indicating high risk, are included in the National Cancer Institute Breast Cancer Risk Assessment Tool, also called the Gail Model.

Another breast cancer risk assessment tool, used in the Women Informed to Screen Depending on Measures of Risk trial, is the Breast Cancer Surveillance Consortium (BCSC) Risk Calculator ( https://tools.bcsc-scc.org/bc5yearrisk/calculator.htm ). The following information is used in that assessment tool:

• History of breast cancer, ductal carcinoma in situ, breast augmentation, or mastectomy

• Age

  /Race/ethnicity

• Number of first-degree relatives (mother, sister, or daughter) diagnosed with breast cancer

• Prior breast biopsies (positive or negative)

• Breast Imaging Reporting and Data System (BI-RADS) breast density (radiologic assessment of breast tissue density by radiologists who interpret mammograms).

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

2/2001: Approved by Medical Policy Advisory Committee (MPAC).

5/14/2002: Code Reference section updated; 173.5, 174.0-174.9, 175.0-175.9, 198.81, 238.3, 239.3, and 611.72 (malignant codes) deleted.

1/17/2003: Policy reviewed; no changes based on Hayes report.

11/19/2004: Code Reference section updated, ICD-9 procedure code range 85.33-85.36, 85.41-85.44 listed separately, ICD-9 diagnosis code V50.41 "Note: Must be filed in conjunction with one of the diagnosis codes listed above." added.

12/27/2006: Code Reference section updated per the 2007 CPT revisions.

1/5/2009: Policy reviewed, additional definitions of "high risk of breast cancer" added to the policy. 

04/20/2011: Policy description and statement unchanged. Removed deleted CPT codes 19180 and 19182 from the Code Reference section.

03/27/2012: Policy reviewed. Policy description updated. Deleted outdated references from the Sources section.

09/03/2013: Definition of high risk clarified and medically necessary indication for those at moderately increased risk of breast cancer removed, except for women with extensive mammographic abnormalities. Added policy statement to indicate that prophylactic mastectomy may be considered medically necessary in patients with such extensive mammographic abnormalities (i.e., calcifications) that adequate biopsy or excision is impossible. Also added that prophylactic mastectomy is considered investigational for all other indications, including but not limited to contralateral prophylactic mastectomy in women with breast cancer who do not meet high risk criteria. Updated high-risk criteria in the policy guidelines and deleted the moderate risk information.

04/30/2014: Policy reviewed; description updated. Policy statement unchanged.

04/06/2015: Policy reviewed; description updated. Policy statements unchanged. Policy guidelines revised to add "another gene mutation associated with increased risk (eg, PTEN, TP53, CDH1, and STK11)" to the criteria for patients with a high risk of breast cancer. Policy guidelines also updated to change "radiation therapy" to "radiotherapy' and add medically necessary and investigative definitions.

08/31/2015: Code Reference section updated for ICD-10. Extended ICD-9 diagnosis code 793.8 to the 5th digit as 793.80 – 793.89. Added ICD-9 diagnosis code V84.01.

05/31/2016: Policy number A.7.01.09 added.

07/01/2016: Policy description updated. Removed medically necessary statement regarding lobular carcinoma in situ. High-risk criteria in Policy Guidelines updated to add lobular carcinoma in situ, revise bullet point regarding BRCA1 and BRCA2 mutation, and to change "20% to 25%" to "20%." Policy Guidelines also updated regarding other factors that may increase the risk of breast cancer.

11/10/2017: Policy description updated to change "mutations" to "variants" and to remove information regarding the types of prophylactic mastectomies. Removed medically necessary statement regarding extensive mammographic abnormalities. Policy Guidelines updated regarding risk factors for breast cancer. Code Reference section updated to remove ICD-9 diagnosis codes 793.80 - 793.89 and ICD-10 diagnosis codes R92.0 - R92.8.

08/08/2018: Policy title changed from "Prophylactic Mastectomy" to "Risk-Reducing Mastectomy." "Prophylactic" changed to "Risk-reducing" throughout the policy to reflect preferred terminology. Policy Guidelines updated regarding breast cancer risk assessment.

08/14/2019: Policy description revised. Policy statements unchanged.

12/19/2019: Code Reference section updated to make note of deleted CPT code.

08/18/2020: Policy description updated regarding risk factors. Policy statements unchanged.

08/30/2021: Policy reviewed. Policy statements unchanged. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity." Code Reference section updated to remove deleted CPT code 19304.

08/10/2022: Policy description updated. Policy statements and Policy Guidelines updated to change "patients" and "women" to "individuals."

08/09/2023: Policy reviewed; no changes.

11/20/2024: Policy reviewed; no changes.

SOURCE(S)

Blue Cross Blue Shield Association Policy # 7.01.09

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy. 

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Covered Codes

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