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MP 7.01.09 Prophylactic Mastectomy

Medical Policy    
Section
Surgery 
Original Policy Date
12/1/95
Last Review Status/Date
Reviewed with literature search/3:2014
Issue
3:2014
  Return to Medical Policy Index

Disclaimer

Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract.  Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage.  Medical technology is constantly changing, and we reserve the right to review and update our policies periodically. 


Description

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.

Background

PMs may be considered in women thought to be at high risk of developing breast cancer, either due to a family history, presence of genetic mutations such as BRCA1 or BRCA2, having received radiation therapy 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 PM may be performed to eliminate the risk of cancer arising elsewhere; chemoprevention and close surveillance are alternative risk reduction strategies. PMs 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]). The use of CPM has risen in recent years 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.(1)

The appropriateness of a PM 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 5 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.


Policy

Prophylactic mastectomy may be considered medically necessary in patients at high risk of breast cancer. (For definitions of risk levels, see Policy Guidelines.)

Prophylactic mastectomy may be considered medically necessary in patients with lobular carcinoma in situ.

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.


Policy Guidelines 

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.

Patients with a high risk of breast cancer may be defined as one or more of the following:

  • a known BRCA1 or BRCA2 mutation or
  • at high risk of BRCA1 or BRCA2 mutation due to a known presence of the mutation in relatives or
  • Li-Fraumeni syndrome or Cowden syndrome or Bannayan-Riley-Ruvalcaba syndrome or a first-degree relative with one of these syndromes or
  • high risk (lifetime risk about 20% to 25% or greater) of developing breast cancer as identified by models that are largely defined by family history or
  • received radiation therapy to the chest between 10 and 30 years of age.

Benefit Application
BlueCard/National Account Issues

Coverage for reconstructive breast surgery is typically provided for patients undergoing prophylactic mastectomies considered medically necessary by the plan.


Rationale 

This policy was created in 1995 and updated regularly with searches of the MEDLINE database. The most recent literature search was performed for the period February 5, 2013, through January 31, 2014. Following is a summary of the key literature.

The policy was initially based on a 1999 TEC Assessment that concluded that prophylactic mastectomy (PM) met the TEC criteria for patients with a family history of breast cancer.(2) The Assessment largely focused on a 1999 retrospective cohort analysis of 639 women with a family history of breast cancer who underwent bilateral PM between 1960 and 1993 at Mayo Clinic.(2) The patients were categorized into 2 groups: high-risk patients had a family history suggestive of hereditary breast cancer (n=214), while the remaining 425 patients were arbitrarily considered to have a moderately increased risk. However, it should be emphasized that all women had some sort of family history of breast cancer. For each group, the reduction in the incidence of mortality due to breast cancer was estimated by comparison with a control group (sisters of high-risk patients) or predicted outcomes (using the Gail model for moderate-risk patients). For patients at moderate risk of breast cancer, 37.4 cancers were predicted by the Gail model, and 4 were observed for an incidence reduction of 89.5%. Approximately 13 moderate-risk women would have to have PM to prevent 1 cancer. For those at high risk of breast cancer, reduction in breast cancer incidence ranged from 90% to 94%. Four to 8 high-risk women would need to undergo PM to prevent 1 occurrence of breast cancer.

While all patients in the Hartmann et al study had a family history of breast cancer, this does not mean that all patients with a family history of breast cancer are candidates for a PM. There is a broad spectrum of family history, ranging from those at high risk due to a family history consistent with hereditary breast cancer to those at more moderate risk, ie, with a single affected relative. The decision of whether to have a PM is a complicated patient-driven risk-benefit analysis of the individual cancer risk. While the cancer risk is greatest for those considered at high risk, whether the cancer risk associated with moderate-risk patients warrants a PM is a difficult question. While high risk is more objectively defined either by a family history alone or the presence of a BRCA1 or BRCA2 mutation, moderate risk may be conferred by a wide range of family histories in association with different breast pathologies.

As of 2014, the National Comprehensive Cancer Network guideline recommends that PM should only be considered in high-risk women, defined as a BRCA1 or BRCA2 mutation or another gene mutation associated with increased risk, a compelling family history and possibly in women with lobular carcinoma in situ (LCIS) or prior thoracic radiation therapy before 30 years of age.(3) Additional genetic mutations that have been associated with a high rate of cancer include TP53 (Li-Fraumeni syndrome) and PTEN (Cowden and Bannayan-Riley-Ruvalcaba syndromes. In patients who received prior radiation therapy to the chest between the ages of 10 and 30 years of age, the increased risk of breast cancer can reach almost 30% by age 55 years.(4) Patients with LCIS, which is usually identified incidental to breast biopsy, are also at increased risk of cancer. In 2011, Oppong and King reported that, compared with the general population, women with LCIS face an 8- to 10-fold increased risk of cancer, equaling 26% after 20 years in 1 study.(5) In a commentary on this review, Visvanathan noted that up to 35% of these women who develop breast cancer have bilateral disease, which is why some undergo bilateral prophylactic mastectomy.(6) In a second commentary, Visscher and Hartmann stated that the distinction between LCIS and atypical lobular hyperplasia is often problematic and based on the degree of lobular involvement. (7) More generally, considerable uncertainty exists about the nature and optimal treatment for LCIS, despite some useful findings from genetic profiling.

Impact of PM on health outcomes

A 2010 Cochrane review examined the impact of PM on mortality and other health outcomes.(8) The authors did not identify any randomized controlled trials (RCTs). Thirty-nine observational studies with some methodologic limitations were identified in the literature search. The studies presented data on 7384 women with a wide range of risk factors for breast cancer who underwent PM. Studies on the incidence of breast cancer and/or disease-specific mortality reported reductions after bilateral PM, particularly for those with BRCA 1/2 mutations. For contralateral prophylactic mastectomy (CPM), studies consistently reported reductions in incidence of contralateral breast cancer but were inconsistent about improvements in disease-specific survival. The authors concluded that, while the available observational data suggest that bilateral PM reduces the rate of breast cancer mortality, more rigorous studies (ideally RCTs) are needed, and that bilateral PM should only be considered among patients at very high risk of disease. Moreover, they concluded that there is insufficient evidence that CPM increases survival.

In 2013, Yao et al evaluated overall survival after CPM by analyzing data from the National Cancer Data Base.(1) The database collects data from 1450 Commission of Cancer-accredited cancer programs. The analysis included 219,983 women who had mastectomy for unilateral breast cancer; 14,994 (7%) of these women underwent CPM at the time of their mastectomy surgery. The overall 5-year survival rate was 80%. In an analysis adjusting for confounding factors, the risk of death was significantly lower in women who had CPM compared with women who did not have CPM. The adjusted hazard ratio (HR) was 0.88 (95% confidence interval [CI], 0.83 to 0.93). The absolute risk of death over 5 years with CPM was 2.0% lower than without CPM. In subgroup analyses, a survival benefit after CPM was found for individuals age 18 to 49 years and age 50 to 69 years, but not in patients 70 years or older. There was a survival benefit for women with stage I and II tumors, but not stage III tumors. Data were not available to do subgroup analyses according to the presence or absence of genetic mutations or family history risk factors.

There may be risks, as well as benefits, associated with CPM. A 2013 study by Miller et al evaluated potential risks associated with CPM at a single institution.(9) Among 600 women treated for unilateral breast cancer, 391 (65%) underwent unilateral mastectomy and 209 (35%) underwent CPM. CPM patients tended to be diagnosed at an earlier stage than unilateral mastectomy patients and were less likely to undergo adjuvant therapy. A total of 402 patients underwent immediate reconstruction surgery, 55% of the unilateral mastectomy group and 90% of the CPM group. Overall, CPM patients had significantly more operative complications (112, 41.6%) than unilateral mastectomy patients (87, 28.6%) (p<0.001). Moreover, there were more major complications in the CPM group. Twenty-nine (13.9%) patients in the CPM group and 16 (4.1%) patients in the unilateral mastectomy group experienced major complications (p=0.001). The most frequent major complications were fixed tissue expander or implant control (CPM patients) and seroma requiring reoperation in unilateral mastectomy patients. In multivariate analysis controlling for type of reconstruction and other factors such as adjuvant therapy and age, CPM remained associated with a significantly higher risk of any complication (odds ratio [OR], 1.53; 95% CI, 1.04 to 2.25) and a significantly higher risk of major complications (OR=2.66; 95% CI, 1.37 to 5.19).

Other representative studies on the impact of PM on health outcomes are described next:

In a 2011 study of 2965 mastectomy patients for unilateral cancer at Memorial Sloan-Kettering Cancer Center, 407 (13%) underwent either immediate (90%) or delayed (within 1 year) CPM.(10) Of patients undergoing CPM, 69% had a family history of breast cancer, 34% had completed clinical genetic counseling, and 9% (37 patients) had BRCA 1/2 mutations. The mean age was 44.8 years (range, 20-80). Sixty-three percent of the index (ie, ipsilateral) cancers were invasive ductal cancer, 22% were pure ductal carcinoma in situ (DCIS), 9% were invasive lobular cancers, and 7% were infiltrating mammary (mixed) cancers. Based on histologic findings from the CPM specimens, 6% of the women had contralateral cancer and 28% had a “high-risk lesion,” defined as atypical ductal or lobular hyperplasia or LCIS. The authors reported a 4- to 5-fold increased risk of developing breast cancer for women with atypical ductal hyperplasia (based on studies from the 1990s) and an 8- to 9-fold risk for women with LCIS (based on studies from the 1970s and early 2000s). On multivariate analysis, patient age (≥50) (OR=3.09; 95% CI, 1.682 to 5.692; p<0.001) and progesterone receptor positivity (OR=3.37; 95% CI, 1.651 to 6.871; p<0.001) were significantly associated with either malignancy or high-risk lesion compared with having only benign findings. The odds ratio for use of hormone replacement therapy for more than 1 year was 2.45 (95% CI, 1.021 to 5.865; p=0.045). The authors did not adjust for multiple comparisons because of the “retrospective and exploratory” nature of the analysis.

In 2012, Chung et al compared the characteristics of 177 women undergoing CPM with 178 age- and stage-matched controls at a single institution.(11) The median age at diagnosis was 48.5 years (range, 24-82). Of the 355 patients, 19.1% had DCIS and the remainder had invasive disease. There was no difference between those who underwent CPM and those who did not in terms of histology, grade, hormone-receptor status, or presence of multifocality. Women who had CPM were twice as likely to have undergone preoperative magnetic resonance imaging (p<0.001). Patients in the CPM group were statistically significantly more likely to have a history of previous breast biopsy, family history of breast cancer, or BRCA gene mutation. Histopathology of the contralateral breast found that 6.6% of the women undergoing CPM had occult cancer; 7 of 11 patients had DCIS. With a median follow-up of 61 months (range, 2-171 months), 1.7% of the women who did not undergo CPM had developed contralateral breast cancer.

Ongoing Clinical Trials

A search of online site ClinicalTrials.gov in February 2014 found one registry study of PM for breast cancer risk reduction (NCT00555503). This registry will examine patient quality of life, cancer occurrence, adverse events, and survival annually for 10 years. The study aims to enroll 500 women.

Summary

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. The literature on PM primarily consists of observational studies and retrospective reviews; however, evidence demonstrates that PM reduces breast cancer incidence and increases survival in high-risk patients. Based on the scientific data consisting of large numbers of patients treated with follow-up, PM for breast cancer risk reduction may be considered medically necessary in patients at high risk of breast cancer. The choice of PM is based on patient tolerance for risk, consideration of the extreme disfiguration and need for additional cosmetic surgery, and the risk reduction offered by PM versus other options.

The use of contralateral prophylactic mastectomy (CPM) in women with unilateral cancer in the other breast has risen in recent years. There are insufficient data on a survival benefit of CPM, particularly for women who do not meet high-risk criteria. Moreover, there are potential risks eg, operative risks associated with CPM. National guidelines, including from the National Comprehensive Care Network, do not recommend that CPM be considered other than for certain high-risk women. Thus, CPM is considered investigational in cases in which the woman does not meet criteria for high risk.

Practice Guidelines and Position Statements

National Comprehensive Cancer Network (NCCN):

  • 2013 (V.1) breast cancer risk reduction guideline states that risk reduction mastectomy (i.e., PM) should “generally be considered only in women with BRCA1/2, or other strongly predisposing gene mutation, compelling family history, or possibly with LCIS or prior thoracic radiation therapy at <30 y of age.”(3)
  • 2014 (V.1) breast cancer guideline state that, except for certain high-risk situations, CPM is discouraged. (12) NCCN notes that the small benefits from CPM in women with unilateral breast cancer must be balanced with the risk of recurrent disease from the ipsilateral breast cancer, psychosocial issues, and risks of CPM.

Society of Surgical Oncology: SSO developed a position statement on PM in 1993 and updated it in 2007. (13) The position statement states that bilateral PM is potentially indicated in patients with:

  • known BRCA 1 or 2 mutations or other genes that strongly predispose susceptibility to breast cancer,
  • a history of multiple first-degree relatives with breast cancer history or multiple successive generations of breast and/or ovarian cancer, or
  • biopsy-confirmed, high-risk histology such as atypical ductal or lobular hyperplasia or LCIS.

The SSO also indicates CPM may be potentially indicated in patients:

  • with high risk (as defined above) of contralateral breast cancer,
  • in whom surveillance would be difficult such as with dense breast tissue or diffuse indeterminate microcalcifications, or
  • to improve symmetry.

References

  1. Yao K, Winchester DJ, Czechura T et al. Contralateral prophylactic mastectomy and survival: report from the National Cancer Data Base, 1998-2002. Breast Cancer Res Treat 2013; 142(3):465-76.
  2. Blue Cross and Blue Shield Association, Technology Evaluation Center (TEC). Bilateral prophylactic mastectomy in women with an increased risk of breast cancer. TEC Assessments 1999; Volume 14, Tab 14.
  3. National Comprehensive Cancer Network. Breast Cancer Risk Reduction. V.1. 2013 Available online at: http://www.nccn.org/professionals/physician_gls/pdf/breast_risk.pdf. Last accessed February, 2014.
  4. Saslow D, Boetes C, Burke W et al. American Cancer Society guidelines for breast screening with MRI as an adjunct to mammography. CA Cancer J Clin 2007; 57(2):75-89.
  5. Oppong BA, King TA. Recommendations for women with lobular carcinoma in situ (LCIS). Oncology (Williston Park) 2011; 25(11):1051-6, 58.
  6. Visvanathan K. The challenges of treating lobular carcinoma in situ. Oncology (Williston Park) 2011; 25(11):1058, 61, 66.
  7. Visscher DW, Hartmann LC. Lobular neoplasia: how to manage with partial understanding. Oncology (Williston Park) 2011; 25(11):1066, 68.
  8. Lostumbo L, Carbine NE, Wallace J. Prophylactic mastectomy for the prevention of breast cancer. Cochrane Database Syst Rev 2010; (11):CD002748.
  9. Miller ME, Czechura T, Martz B et al. Operative risks associated with contralateral prophylactic mastectomy: a single institution experience. Ann Surg Oncol 2013; 20(13):4113-20.
  10. King TA, Gurevich I, Sakr R et al. Occult malignancy in patients undergoing contralateral prophylactic mastectomy. Ann Surg 2011; 254(1):2-7.
  11. Chung A, Huynh K, Lawrence C et al. Comparison of patient characteristics and outcomes of contralateral prophylactic mastectomy and unilateral total mastectomy in breast cancer patients. Ann Surg Oncol 2012; 19(8):2600-6.
  12. National Comprehensive Cancer Network. Breast Cancer. V.1.2014. Available online at: http://www.nccn.org/professionals/physician_gls/pdf/breast.pdf. Last accessed February, 2014.
  13. Giuliano AE, Boolbol S, Degnim A et al. Society of Surgical Oncology: position statement on prophylactic mastectomy. Approved by the Society of Surgical Oncology Executive Council, March 2007. Ann Surg Oncol 2007; 14(9):2425-7.

  

Codes

Number

Description

CPT  19303 Mastectomy, simple, complete 
  19304 Mastectomy, subcutaneous
ICD-9 Procedure  85.33 Unilateral subcutaneous mammectomy with synchronous implant
   85.34 Other unilateral subcutnaeous mammectomy
   85.35 Bilateral subcutaneous mammectomy with synchronous implant
   85.36 Other bilateral subcutaneous mammectomy
   85.41  Unilateral simple mastectomy 
   85.42 Bilateral simple mastectomy
ICD-9 Diagnosis  233.0 Carcinoma in situ of breast 
  V50.41 Elective surgery for purposes other than remedying health states; prophylactic organ removal; breast
HCPCS  No Code   
ICD-10-CM (effective 10/1/15) D05.0-D05.9 Carcinoma in situ of breast code range
   Z15.01 Genetic susceptibility to malignant neoplasm breast
   Z40.01 Encounter for prophylactic removal of breast
ICD-10-PCS (effective 10/1/15)    ICD-10-PCS codes are only used for inpatient services.
   0HBT0ZZ, 0HBU0ZZ, 0HBV0ZZ Surgical, skin or breast, excision, breast, open, code by body part (right breast, left breast, or bilateral breasts)
   0H0T07Z, 0H0T0JZ, 0H0T0KZ, 0H0U07Z, 0H0U0JZ, 0H0U0KZ, 0H0V37Z, 0H0V0JZ, 0H0V0KZ Surgical, skin or breast, alteration, breast, open, code by body part (right breast, left breast, or bilateral breasts) and qualifier (autologous tissue substitute, synthetic substitute, nonautologous tissue substitute)
Type of Service  Surgery 
Place of Service  Inpatient 

 


Index 

Female Mastectomy as a Prophylaxis
Mastectomy, Female, as a Prophylaxis for Breast Cancer
Prophylactic Mastectomy


Policy History

 

Date Action Reason
12/01/95 Add to Surgery section New policy
12/01/99 Replace policy Content updated; policy statement revised; based on 1999 TEC Assessment
7/12/02 Replace policy Policy reviewed by consensus; new review date only
07/17/03 Replace policy Policy reviewed by consensus; no changes in policy; no further review scheduled
12/11/08 Replace policy  Policy returned to active review and updated with literature search. Reference numbers 4 and 5 added. Policy statements updated with additional high and moderate risk groups. 
02/10/11 Replace policy Policy updated with literature search; reference numbers 5 and 7 added and reference 6 updated; policy statements unchanged.
2/09/12 Replace policy Policy updated with literature search; the term "p53" was updated to the more current "TP53" terminology in the Policy Guidelines; reference numbers 6-7, 10 added; policy statements unchanged.
03/14/13 Replace policy
Policy updated with literature review through February 5, 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. New investigational statement for contralateral prophylactic mastectomy among women with cancer in the other breast who do not meet one of the medically indicated conditions. Information added on lobular carcinoma in situ and trends in contralateral prophylactic mastectomy. References 5-7, 11-14 and 17 added.
3/13/14 Replace policy Policy updated with literature review through January 31, 2014. No change to policy statements. References 1 and 9 added; NCCN references updated.