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Prophylactic mastectomy (PM) is defined as the removal of the breast in the absence of malignant disease to reduce the risk of breast cancer occurrence. Prophylactic mastectomy may be considered in women thought to be at high risk of developing breast cancer, either due to family history, presence of genetic mutations such as BRCA1 or BRCA2, having received radiotherapy to the chest, or the presence of lesions associated with an increased cancer risk such as lobular carcinoma in situ (LCIS). LCIS is both a risk factor for all types of cancer, including bilateral cancer, and in some cases, a precursor for invasive lobular cancer. For those who develop invasive cancer, up to 35% may have bilateral cancer. Therefore, bilateral prophylactic mastectomy may be performed to eliminate the risk of cancer arising elsewhere; chemoprevention and close surveillance are alternative risk reduction strategies. Prophylactic 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 an invasive cancer (ie, contralateral prophylactic mastectomy [CPM]). Use of CPM has increased in the United States. An analysis of data from the National Cancer Data Base found that the rate of CPM in women diagnosed with unilateral stage I-III breast cancer increased from approximately 4% in 1998 to 9.4% in 2002.
Two types of prophylactic mastectomies can be performed; either total (also referred to as simple) mastectomy, in which the intent is to remove the entire breast and nipple areolar complex, and subcutaneous mastectomy, where the nipple areolar complex is left intact for a more natural appearance. While breast tissue is certainly left behind in a subcutaneous mastectomy, residual breast tissue in the axillary tail and skin flaps may be identified after a total mastectomy. However, from a purely prophylactic standpoint, a total mastectomy is generally preferred over a subcutaneous mastectomy because there is less residual breast tissue.
The appropriateness of a prophylactic 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, such as the Claus model and the Gail model. Breast cancer history in first- and second-degree relatives is used to estimate breast cancer risk in the Claus model. The Gail model uses the following five risk factors: age at evaluation, age at menarche, age at first live birth, number of breast biopsies, and number of first-degree relatives with breast cancer. Moreover, the choice of prophylactic 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 prophylactic 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 Genetic Testing for Hereditary Breast and/or Ovarian Cancer medical policy.
Prophylactic mastectomy may be considered medically necessary in patients at high risk of breast cancer. (For definitions of risk levels, see policy guidelines, below).
Prophylactic mastectomy may be considered medically necessary in patients with such extensive mammographic abnormalities (i.e., calcifications) that adequate biopsy or excision is impossible.
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.
It is strongly recommended that all candidates for prophylactic mastectomy undergo counseling regarding cancer risks from a health professional skilled in assessing cancer risk other than the operating surgeon and discussion of the various treatment options, including increased surveillance or chemoprevention with tamoxifen or raloxifene.
There is no standardized method for determining a woman’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:
A number of other factors may increase the risk of breast cancer but do not by themselves indicate high risk. 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 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. Risk factors in the model can be accessed online (http://www.cancer.gov/bcrisktool/Default.aspx).
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 Nervous/Mental Conditions, 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 Medically Necessary, “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.
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.
Blue Cross Blue Shield Association Policy # 7.01.09
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.
CPT copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.