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Protocol Prophylactic Mastectomy (70109) Medical Benefit Preauthorization Yes Effective Date: 10/01/16 Next Review Date: 07/17 Review Dates: 09/07, 09/08, 09/09, 09/10, 07/11, 07/12, 07/13, 07/14, 07/15, 07/16 Preauthorization is required. The following Protocol contains medical necessity criteria that apply for this service. The criteria are also applicable to services provided in the local Medicare Advantage operating area for those members, unless separate Medicare Advantage criteria are indicated. If the criteria are not met, reimbursement will be denied and the patient cannot be billed. Please note that payment for covered services is subject to eligibility and the limitations noted in the patient’s contract at the time the services are rendered. Populations Individuals: • With high risk of breast cancer • With extensive mammographic abnormalities precluding incision or biopsy Individuals: • With unilateral breast cancer but are not otherwise at high risk Interventions Comparators Interventions of interest are: Comparators of interest • Prophylactic are: • Active surveillance mastectomy • Standard care Interventions of interest are: • Contralateral prophylactic mastectomy Comparators of interest are: • Active surveillance • Standard care Outcomes Relevant outcomes include: • Overall survival • Disease-specific survival • Functional outcomes • Treatment-related morbidity Relevant outcomes include: • Overall survival • Disease-specific survival • Functional outcomes • Treatment-related morbidity 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. Summary of Evidence The evidence for prophylactic mastectomy (PM) in women who have high risk of breast cancer or extensive mammographic abnormalities precluding incision or biopsy includes a TEC Assessment and systematic review of observational studies. Relevant outcomes are overall survival, disease-specific survival, functional outcomes, and treatment-related morbidity. The studies found that PM reduces breast cancer incidence and increases survival in select patients. The evidence is sufficient to determine qualitatively that the technology results in a meaningful improvement in the net health outcome. The evidence for contralateral prophylactic mastectomy (CPM) in women who have unilateral breast cancer but are not otherwise at high risk includes observational studies. Relevant outcomes are overall survival, diseasespecific survival, functional outcomes, and treatment-related morbidity. Available studies do not clearly demonstrate a survival benefit in women without high-risk criteria. Moreover, there are potential risks (e.g., surgical risks) associated with CPM. National guidelines, including those from the National Comprehensive Care Page 1 of 5 Protocol Prophylactic Mastectomy Last Review Date: 07/16 Network, do not recommend that CPM be considered other than for certain high-risk women. The evidence is insufficient to determine the effects of the technology on health outcomes. 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 such extensive mammographic abnormalities (i.e., calcifications) that adequate biopsy or excision is impossible. Prophylactic mastectomy is considered investigational for all other indications. 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. 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 or • a known BRCA1 or BRCA2 mutation or • another gene mutation associated with high risk, e.g., TP53 (Li-Fraumeni syndrome), PTEN (Cowden syndrome, Bannayan-Riley-Ruvalcaba syndrome), CDH1, and STK11 or • high risk (lifetime risk about 20% 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 the ages of 10 and 30 years. 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). Contralateral prophylactic mastectomy is discouraged in women with a history of or current diagnosis of unilateral breast cancer, when the preceding criteria for high risk are not met. When considered, the small benefit from the contralateral prophylactic mastectomy, the risk of recurrence from the known ipsilateral breast cancer, psychological issues and social issues (existing, as well as those which may be precipitated by the anticipated mastectomy) and the risk of the surgery must be evaluated. After breast conserving treatment for breast cancer, a contralateral prophylactic mastectomy is very strongly discouraged.13 Page 2 of 5 Protocol Prophylactic Mastectomy Last Review Date: 07/16 Background Prophylactic mastectomy (PM) may be considered in women thought to be at high risk of developing breast cancer, either due to family history, presence of genetic mutations (e.g., 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 (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 (i.e., 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 2002.1 The appropriateness of 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 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 PM is based on patient tolerance for risk, consideration of changes to appearance and need for additional cosmetic surgery, and the risk reduction offered by PM versus other options. Regulatory Status Mastectomy is a surgical procedure and, as such, is not subject to regulation by the U.S. Food and Drug Administration. Related Protocols Genetic Cancer Susceptibility Panels Using Next-Generation Sequencing Genetic Testing for Hereditary Breast/Ovarian Cancer Syndrome (BRCA1/BRCA2) Genetic Testing for PALB2 Mutations Services that are the subject of a clinical trial do not meet our Technology Assessment Protocol criteria and are considered investigational. For explanation of experimental and investigational, please refer to the Technology Assessment Protocol. It is expected that only appropriate and medically necessary services will be rendered. We reserve the right to conduct prepayment and postpayment reviews to assess the medical appropriateness of the above-referenced procedures. Some of this Protocol may not pertain to the patients you provide care to, as it may relate to products that are not available in your geographic area. Page 3 of 5 Protocol Prophylactic Mastectomy Last Review Date: 07/16 References We are not responsible for the continuing viability of web site addresses that may be listed in any references below. 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):465-476. PMID 24218052 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.2. 2015 http://www.nccn.org/professionals/physician_gls/pdf/breast_risk.pdf. Accessed July 13, 2015. 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. Mar-Apr 2007; 57(2):75-89. PMID 17392385 5. Oppong BA, King TA. Recommendations for women with lobular carcinoma in situ (LCIS). Oncology (Williston Park). Oct 2011; 25(11):1051-1056, 1058. PMID 22106556 6. Lostumbo L, Carbine NE, Wallace J. Prophylactic mastectomy for the prevention of breast cancer. Cochrane Database Syst Rev. 2010(11):CD002748. PMID 21069671 7. Nichols HB, Berrington de Gonzalez A, Lacey JV, Jr., et al. Declining incidence of contralateral breast cancer in the United States from 1975 to 2006. J Clin Oncol. Apr 20 2011; 29(12):1564-1569. PMID 21402610 8. Molina-Montes E, Perez-Nevot B, Pollan M, et al. Cumulative risk of second primary contralateral breast cancer in BRCA1/BRCA2 mutation carriers with a first breast cancer: A systematic review and meta-analysis. Breast. Dec 2014; 23(6):721-742. PMID 25467311 9. 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):1000-1010. PMID 24950272 10. 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):3448-3456. PMID 25047478 11. Jatoi I, Parsons HM. Contralateral prophylactic mastectomy and its association with reduced mortality: evidence for selection bias. Breast Cancer Res Treat. Nov 2014; 148(2):389-396. PMID 25301088 12. 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):3231-3239. PMID 25081341 13. 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):3474-3480. PMID 26001862 14. 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):4113-4120. PMID 23868655 15. 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):3297-3303. PMID 25047470 16. National Comprehensive Cancer Network. NCCN Guidelines Version 2, 2015. Genetic/Familial High-Risk Assessment: Breast and Ovarian. www.nccn.org/professionals/physician_gls/pdf/genetics_screening.pdf. Accessed July 13, 2015. 17. National Comprehensive Cancer Network. Breast Cancer. V.2.2015. http://www.nccn.org/professionals/physician_gls/pdf/breast.pdf. Accessed July 13, 2015. Page 4 of 5 Protocol Prophylactic Mastectomy Last Review Date: 07/16 18. 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. Sep 2007; 14(9):2425-2427. PMID 17597344 19. National Cancer Institute. Fact Sheet: Surgery to Reduce the Risk of Breast Cancer. 2012, reviewed in 2013; http://www.cancer.gov/cancertopics/factsheet/Therapy/risk-reducing-surgery. Accessed July 13, 2015. Page 5 of 5