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Indications

(1) Does the request meet this criterion: lobular carcinoma in situ,? 
(2) Does the request meet this criterion: a known BRCA1 or BRCA2 variant,? 
(3) Does the request meet this criterion: another gene variant associated with increased risk, eg, TP53 (Li-Fraumeni syndrome), PTEN (Cowden syndrome, Bannayan-Riley-Ruvalcaba syndrome), CDH1, and STK11, and PALB2 or? 
(4) Does the request meet this criterion: received radiotherapy to the chest before 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? 
(5) Does the request meet this criterion: History of breast cancer, ductal carcinoma in situ, breast augmentation, or mastectomy? 

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Original Document

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500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 1 (401) 274-4848 WWW.BCBSRI.COM


EFFECTIVE DATE: 02|01|2026 POLICY LAST REVIEWED: 10|15|2025

OVERVIEW 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.

MEDICAL CRITERIA Not applicable

PRIOR AUTHORIZATION
Not applicable

POLICY STATEMENT Medicare Advantage Plans and Commercial Products
Risk reducing mastectomy is a covered service.

COVERAGE Benefits may vary between groups and contracts. Please refer to the appropriate Benefit Booklet, Evidence of Coverage, or Subscriber Agreement for applicable surgery benefits/coverage.

BACKGROUND Risk-reducing mastectomy may be considered in women thought to be at high-risk of developing breast cancer, either due to family history, presence of genetic variants (eg, BRCA1, BRCA2), 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 U.S. An analysis of data from the National Cancer Database found that the rate of contralateral risk-reducing mastectomy in women 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. 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.

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

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 2 (401) 274-4848 WWW.BCBSRI.COM

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: • lobular carcinoma in situ, • a known BRCA1 or BRCA2 variant, • another gene variant associated with increased risk, eg, TP53 (Li-Fraumeni syndrome), PTEN (Cowden syndrome, Bannayan-Riley-Ruvalcaba syndrome), CDH1, and STK11, and PALB2 or • received radiotherapy to the chest before 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.ucdavis.edu/BC5yearRisk/#/). 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) • Menopausal status; • Body mass index (BMI); • Maternal age at first birth.

CODING Medicare Advantage Plans and Commercial Products
The following code(s) are covered for Medicare Advantage Plans and Commercial Products: 19303 Mastectomy, simple, complete

RELATED POLICIES Gender Affirming Care Mastectomy Treatment, Breast Reconstruction and Hospital Stays Mandates

PUBLISHED Provider Update, December 2025 Provider Update, November 2024 Provider Update, October 2023 Provider Update, July 2022 Provider Update, May 2021

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. Dec 2013; 142(3): 465-76. PMID 24218052

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 3 (401) 274-4848 WWW.BCBSRI.COM

  1. Baskin AS, Wang T, Bredbeck BC, et al. Trends in Contralateral Prophylactic Mastectomy Utilization for Small Unilateral Breast Cancer. J Surg Res. Jun 2021; 262: 71-84. PMID 33548676
  2. McCarthy AM, Guan Z, Welch M, et al. Performance of Breast Cancer Risk-Assessment Models in a Large Mammography Cohort. J Natl Cancer Inst. May 01 2020; 112(5): 489-497. PMID 31556450
  3. Watt GP, John EM, Bandera EV, et al. Race, ethnicity and risk of second primary contralateral breast cancer in the United States. Int J Cancer. Jun 01 2021; 148(11): 2748-2758. PMID 33544892
  4. Li X, You R, Wang X, et al. Effectiveness of Prophylactic Surgeries in BRCA1 or BRCA2 Mutation Carriers: A Meta-analysis and Systematic Review. Clin Cancer Res. Aug 01 2016; 22(15): 3971-81. PMID 26979395
  5. Ludwig KK, Neuner J, Butler A, et al. Risk reduction and survival benefit of prophylactic surgery in BRCA mutation carriers, a systematic review. Am J Surg. Oct 2016; 212(4): 660-669. PMID 27649974
  6. Honold F, Camus M. Prophylactic mastectomy versus surveillance for the prevention of breast cancer in women's BRCA carriers. Medwave. Jul 09 2018; 18(4): e7161. PMID 30052622
  7. Carbine NE, Lostumbo L, Wallace J, et al. Risk-reducing mastectomy for the prevention of primary breast cancer. Cochrane Database Syst Rev. Apr 05 2018; 4(4): CD002748. PMID 29620792
  8. Nichols HB, Berrington de González A, Lacey JV, et al. Declining incidence of contralateral breast cancer in the United States from 1975 to 2006. J Clin Oncol. Apr 20 2011; 29(12): 1564-9. PMID 21402610
  9. Molina-Montes E, Pérez-Nevot B, Pollán M, et al. Cumulative risk of second primary contralateral breast cancer inBRCA1/BRCA2 mutation carriers with a first breast cancer: A systematic review and meta- analysis. Breast. Dec 2014;23(6): 721-42. PMID 25467311
  10. Fayanju OM, Stoll CR, Fowler S, et al. Contralateral prophylactic mastectomy after unilateral breast cancer: a systematic review and meta-analysis. Ann Surg. Dec 2014; 260(6): 1000-10. PMID 24950272
  11. Kurian AW, Canchola AJ, Ma CS, et al. Magnitude of reduction in risk of second contralateral breast cancer with bilateral mastectomy in patients with breast cancer: Data from California, 1998 through 2015. Cancer. Mar 01 2020; 126(5): 958-970. PMID 31750934
  12. Wong SM, Freedman RA, Sagara Y, et al. Growing Use of Contralateral Prophylactic Mastectomy Despite no Improvement in Long-term Survival for Invasive Breast Cancer. Ann Surg. Mar 2017; 265(3): 581-589. PMID 28169929
  13. Kruper L, Kauffmann RM, Smith DD, et al. Survival analysis of contralateral prophylactic mastectomy: a question of selection bias. Ann Surg Oncol. Oct 2014; 21(11): 3448-56. PMID 25047478
  14. Pesce C, Liederbach E, Wang C, et al. Contralateral prophylactic mastectomy provides no survival benefit in young women with estrogen receptor-negative breast cancer. Ann Surg Oncol. Oct 2014; 21(10): 3231-
  15. PMID 25081341
  16. Yang Y, Pan L, Shao Z. Trend and survival benefit of contralateral prophylactic mastectomy among men with stage I-III unilateral breast cancer in the USA, 1998-2016. Breast Cancer Res Treat. Dec 2021; 190(3): 503-515. PMID 34554371
  17. Murphy AI, Asadourian PA, Mellia JA, et al. Complications Associated with Contralateral Prophylactic Mastectomy: A Systematic Review and Meta-Analysis. Plast Reconstr Surg. Oct 01 2022; 150: 61S-72S. PMID 35943952
  18. Schroeder MC, Tien YY, Erdahl LM, et al. The relationship between contralateral prophylactic mastectomy and breastreconstruction, complications, breast-related procedures, and costs: A population- based study of health insurance data.Surgery. Nov 2020; 168(5): 859-867. PMID 32819721
  19. Silva AK, Lapin B, Yao KA, et al. The Effect of Contralateral Prophylactic Mastectomy on Perioperative Complications in Women Undergoing Immediate Breast Reconstruction: A NSQIP Analysis. Ann Surg Oncol. Oct 2015; 22(11): 3474-80. PMID 26001862
  20. Miller ME, Czechura T, Martz B, et al. Operative risks associated with contralateral prophylactic mastectomy: a single institution experience. Ann Surg Oncol. Dec 2013; 20(13): 4113-20. PMID 23868655
  21. Eck DL, Perdikis G, Rawal B, et al. Incremental risk associated with contralateral prophylactic mastectomy and the effect on adjuvant therapy. Ann Surg Oncol. Oct 2014; 21(10): 3297-303. PMID 25047470

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 4 (401) 274-4848 WWW.BCBSRI.COM

  1. Tischkowitz M, Balmaña J, Foulkes WD, et al. Management of individuals with germline variants in PALB2: a clinical practice resource of the American College of Medical Genetics and Genomics (ACMG). Genet Med. Aug 2021; 23(8):1416-1423. PMID 33976419
  2. Hanson H, Astiazaran-Symonds E, Amendola LM, et al. Management of individuals with germline pathogenic/likely pathogenic variants in CHEK2: A clinical practice resource of the American College of Medical Genetics and Genomics (ACMG). Genet Med. Oct 2023; 25(10): 100870. PMID 37490054
  3. Pal T, Schon KR, Astiazaran-Symonds E, et al. Management of individuals with heterozygous germline pathogenic variants in ATM: A clinical practice resource of the American College of Medical Genetics and Genomics (ACMG). Genet Med. Jan 2025; 27(1): 101243. PMID 39636577
  4. Tung NM, Boughey JC, Pierce LJ, et al. Management of Hereditary Breast Cancer: American Society of Clinical Oncology, American Society for Radiation Oncology, and Society of Surgical Oncology Guideline. J Clin Oncol. Jun 20 2020; 38(18):2080-2106. PMID 32243226
  5. Boughey JC, Attai DJ, Chen SL, et al. Contralateral Prophylactic Mastectomy (CPM) Consensus Statement from the American Society of Breast Surgeons: Data on CPM Outcomes and Risks. Ann Surg Oncol. Oct 2016; 23(10): 3100-5. PMID 27469117
  6. National Cancer Institute. Fact Sheet: Surgery to Reduce the Risk of Breast Cancer. 2025; https://www.cancer.gov/types/breast/risk-reducing-surgery-fact-sheet. Accessed July 18, 2025.
  7. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Breast Cancer Risk Reduction. Version 2.2025. https://www.nccn.org/professionals/physician_gls/pdf/breast_risk.pdf. Accessed July 18, 2025.
  8. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Breast Cancer. Version 4.2025. https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf. Accessed July 16, 2025.
  9. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Genetic/Familial High-Risk Assessment: Breast, Ovarian, Pancreatic, and Prostate. Version 1.2026. https://www.nccn.org/professionals/physician_gls/pdf/genetics_screening.pdf. Accessed July 17, 2025.
  10. Singh P, Agnese DM, Amin M, et al. Society of Surgical Oncology Breast Disease Site Working Group Statement on Bilateral Risk-Reducing Mastectomy: Indications, Outcomes, and Risks. Ann Surg Oncol. Feb 2025; 32(2): 899-911. PMID 39538100

  11. Singh P, Agnese D, Amin M, et al. Society of Surgical Oncology Breast Disease Site Working Group Statement on Contralateral Mastectomy: Indications, Outcomes, and Risks. Ann Surg Oncol. Apr 2024; 31(4): 2212-2223. PMID 38261126

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    This medical policy is made available to you for informational purposes only. It is not a guarantee of payment or a substitute for your medical judgment in the treatment of your patients. Benefits and eligibility are determined by the member's subscriber agreement or member certificate and/or the employer agreement, and those documents will supersede the provisions of this medical policy. For information on member-specific benefits, call the provider call center. If you provide services to a member which are determined to not be medically necessary (or in some cases medically necessary services which are non-covered benefits), you may not charge the member for the services unless you have informed the member and they have agreed in writing in advance to continue with the treatment at their own expense. Please refer to your participation agreement(s) for the applicable provisions. This policy is current at the time of publication; however, medical practices, technology, and knowledge are constantly changing. BCBSRI reserves the right to review and revise this policy for any reason and at any time, with or without notice. Blue Cross & Blue Shield of Rhode Island is an independent licensee of the Blue Cross and Blue Shield Association.

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500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 5 (401) 274-4848 WWW.BCBSRI.COM

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