Pending Policies - Surgery


Prophylactic Mastectomy (PM)

Number:SUR716.015

Effective Date:11-15-2017

Coverage:

*CAREFULLY CHECK STATE REGULATIONS AND/OR THE MEMBER CONTRACT*

This medical policy does NOT address Gender Reassignment Services (Transgender Services). This medical policy IS NOT TO BE USED for Gender Reassignment Services. Refer to SUR717.001, Gender Assignment Surgery and Gender Reassignment Surgery and Related Services

Prophylactic mastectomy (PM) may be considered medically necessary in patients at high-risk of breast cancer, which includes one or more of the following indications:

Lobular carcinoma in situ (LCIS); or

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

Another gene mutation associated with high-risk, e.g., TP53 (Li-Fraumeni syndrome), PTEN (Cowden syndrome, Bannayan-Riley-Ruvalcaba syndrome), CDH1, and STK11, or a first-degree relative with one of those syndromes; or

High-risk (lifetime risk about 20% or greater) of developing breast cancer as identified by models (Claus or Gail) that are largely defined by family history; or

Received radiation therapy to the chest between 10 and 30 years of age.

PM may be considered medically necessary in patients with such extensive mammographic abnormalities (i.e., calcifications) that adequate biopsy or excision is impossible.

Contralateral PM (CPM) may be considered medically necessary for women who have been diagnosed with breast cancer in the opposite breast.

PM is considered experimental, investigational and/or unproven for all other indications, including but not limited to:

Unilateral or bilateral PM in women at moderate-risk of breast cancer;

Uncontrolled progress of inflammatory breast disease in one or both breasts (e.g., chronic mastitis, macrocystic or fibrocystic disease).

Documentation for PM: All confirmatory lab and pathology reports and/or progress notes shall accompany any request or claim for mastectomy procedures. In the absence of documentation or confirmatory reports, this procedure will be considered cosmetic.

NOTE 1: This policy does not address coverage for any form of radical mastectomy, partial (segmental) mastectomy, or lumpectomy, as PM is a form of breast surgery that does not have a diagnosis of malignancy confirmed by biopsy.

Calculation of Breast Cancer Risk Assessment Tools: The websites available to calculate the risk of breast cancer includes, but is not limited to the following:

For the Gail Model from the National Cancer Institute at the National Institutes of Health (breast cancer risk assessment tool) = www.cancer.gov.

For the Claus Model, it is only available to download as an application to an electronic device.

For the BRCAPRO Model from University of Southwestern (breast health) = www4.utsouthwestern.edu.

For the Tyrer-Cuzick Model = www.ems-trials.org.

NOTE 2: Breast cancer risk assessment online tools may be frequently updated or changed. 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.

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. PM is also known as preventive mastectomy and is typically bilateral.

Background

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 National Comprehensive Cancer Network (NCCN) identifies PM in their guidelines as a risk-reduction mastectomy (RRM). (3) PM may be performed unilaterally in a patient who has previously undergone a mastectomy in the opposite breast for an invasive cancer and is at risk for developing cancer in the remaining breast.

There are several PM procedures, which are distinguished by the amount of breast tissue and other tissues that are removed. These procedures include:

Simple mastectomy (SM) [also known as total mastectomy (TM)]: The entire breast is removed, including all the breast tissue, nipple-areola complex, and a small portion of the overlying skin, preserving muscle, fascia, and axillary lymph nodes.

Skin-sparing mastectomy (SSM): A small (keyhole) incision, circling the areola, is made. Even though the opening is smaller, the same amount of breast tissue is removed. The areola complex cannot be preserved as the breast ductal system travels through this complex. Scarring is negligible and 90% of the skin is preserved. Reconstruction is performed at the same time, using tissue from the patient’s abdomen or latissimus dorsi (back) muscles.

Subcutaneous mastectomy (SCM): The tumor and breast tissue are removed, sparing the skin, lymphatic drainage system, and nipple-areola complex. The breast can be reconstructed by creating a submuscular or subcutaneous pocket for an implant. The reconstruction may be easier, but if SCM is done for cancer, some cancer cells may remain undetected.

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 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. 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.

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), as well as other risk models discussed in the coverage section.

Candidates for PM may have undergone or may undergo counseling regarding cancer risk from a provider skilled in assessing cancer risk other than the surgeon or oncologist, in addition to various treatment options, surveillance, or chemoprevention with tamoxifen or raloxifene.

Special Comment: Ductal carcinoma in situ (DCIS) is the most common type of breast cancer. Ductal invasive breast cancer begins in the milk duct lining, whereas DCIS is noninvasive, found in the milk duct lining and has not spread outside of the duct to other areas of the breast. DCIS may become an invasive cancer. In contrast, lobular carcinoma in situ (LCIS) is a condition in which abnormal cells are found in the lobules of the breast. LCIS is a development of atypical cells that may lead to a tumor which is either benign or malignant.

Rationale:

This policy was created in 1990 and updated regularly with searches of the MedLine database. The most recent literature search was performed through June 6, 2016. Following is a summary of key findings.

Prophylactic Mastectomy (PM)

The policy was initially based on a 1999 Blue Cross Blue Shield Association (BCBSA) Technical Evaluation Center (TEC) Assessment that concluded 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 that found 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.

As of 2016, the National Comprehensive Cancer Network (NCCN) guideline recommends that PM should only be considered in high-risk women, defined as having a BRCA1 or BRCA2 mutation or another gene mutation associated with increased risk (e.g., PTEN [Cowden and Bannayan-Riley-Ruvalcaba syndromes], TP53 [Li-Fraumeni syndrome], CDH1, STK11), a compelling family history, and possibly in women with lobular carcinoma in situ (LCIS) or prior thoracic radiotherapy before 30 years of age. (3) In patients who received radiotherapy 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)

A 2010 Cochrane review examined the impact of PM on mortality and other health outcomes. (6) 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 BRCA1 or BRCA2 mutations. The authors concluded that, while the available observational data suggested bilateral PM reduces the rate of breast cancer mortality, more rigorous studies (ideally RCTs) were needed, and that bilateral PM should only be considered among patients at very high-risk of disease.

Section Summary: PM

Evidence from systematic reviews found that reduction in breast cancer incidence is reduced and breast cancer survival is increased in women at high risk of breast cancer, especially those with BRCA1 or BRCA2 and selected other mutations and those with a compelling family history.

Contralateral Prophylactic Mastectomy (CPM)

Incidence of Second Primary Breast Cancer

The potential for CPM to impact survival is related to its association with a reduced risk of subsequent primary breast cancer in the other breast (i.e., contralateral breast cancer [CBC]). In general, according to data from the U.S. Surveillance, Epidemiology and End Results (SEER) database, annual rates of CBC were stable between 1975 and 1985, after which rates declined about 3% per year (95% confidence interval [CI], 2.7% to 3.5%). (7) Beginning in 1990, the annual decline in CBC rates was only in women with estrogen receptor-positive cancer, with no decrease in women with estrogen receptor-negative cancer. The investigators suggested that the decrease in CBC rates after estrogen receptor-positive cancer may be attributed at least in part to the increased availability of adjuvant hormone therapies.

Studies were sought on the risk of CBC in women who meet high-risk criteria versus average-risk criteria. In 2014, Molina-Montes et al. published a systematic review of studies on the risk of a second primary breast cancer in women with and without BRCA1 or BRCA2 mutations. (8) Twenty studies were included; 12 retrospective cohort studies, 2 prospective cohort studies, and 6 case-control studies. Most studies included only women who had undergone genetic testing; it is likely that even those who tested negative had other risk factors that motivated testing. A meta-analysis found that the cumulative risk of a second primary breast cancer at 5 years after initial diagnosis was 14% (95% CI, 9% to 19%) in BRCA1 or BRCA2 mutation carriers and 3% (95% CI, 2% to 5%) in non-carriers. Cumulative risks of a second primary cancer at 10 years after initial diagnosis was 22% (95% CI, 18% to 27%) in BRCA1 or BRCA2 mutation carriers and 5% (95% CI, 3% to 7%) in non-carriers.

Survival

As is the case for bilateral PM, no RCTs evaluating the effect of CPM on health outcomes have been published. There are a number of observational studies, including some with large sample sizes, and a systematic review of observational studies. The systematic review did reveal the cumulative risk of a second primary breast cancer did increase from the 5 year results to the 10-year review for those patients in BRCA1 or BRCA2 mutation carriers at a higher rate when compared to non-carriers.

A systematic review and meta-analysis of studies on CPM was published in 2014 by Fayanju et al. (9) The authors searched for published studies that compared the incidence of CBC in women with unilateral disease who did and did not undergo CPM. Fourteen observational studies met eligibility criteria and were included in the meta-analysis. In a meta-analysis of 4 studies, mortality from breast cancer was lower in the group that had CPM (relative risk [RR], 0.69; 95% CI, 0.56 to 0.85). Moreover, in a meta-analysis of data from 6 studies, overall survival (OS) was significantly higher in patients who underwent CPM (n=10,666) than those who had no CPM (n=145,490) (RR=1.09; 95% CI, 1.06 to 1.11). The authors also conducted a subgroup analysis by risk level. Studies in which all patients were BRCA mutation carriers and studies in which all patients had a family history of breast cancer (4 studies) were categorized as indicating higher familial/genetic risk. Together, the studies included 618 patients who had CPM and 1318 patients who did not. In a meta-analysis limited to these 4 studies, neither OS nor mortality from breast cancer differed significantly among women who had or did not have CPM. The relative risk of breast cancer mortality with and without CPM was 0.66 (95% CI, 0.27 to 1.64). For OS with and without CPM, the relative risk was 1.09 (95% CI, 0.97 to 1.24). The absolute reduction in the risk of metachronous breast cancer did not differ in women with and without CPM when data from all 8 studies were analyzed (risk difference [RD], -18.0%; 95% CI, -42.0% to 5.9%, but was significantly lower in women with CPM in the 4 studies exclusively enrolling women at increased familial/genetic risk (RD = -24.0%; 95% CI, -35.6% to -12.4%). Commenting on the totality of findings, the authors stated that the improvement in survival after CPM in the general breast cancer population was likely not due to a decreased incidence of contralateral breast cancer, but rather was secondary to selection bias (e.g., CPM recipients may be otherwise healthier and have better access to health care).

Studies in the Fayanju meta-analysis were published between 1997 and 2005. More recent large observational analyses are described below.

Other analyses have also suggested that the association between CPM and reduced mortality identified in some data analyses can be attributed at least in part to selection of a healthier cohort of women for CPM. (10, 11) In particular, a 2014 analysis by Kruper et al. of a large dataset from the SEER database looked at CBC and survival outcomes. (10) The investigators conducted a case-control analysis including 28,015 CPM patients and 28,015 unilateral mastectomy patients, matched on age group, race/ethnicity, extent of surgery, tumor grade, tumor classification, node classification, estrogen receptor status, and propensity score. The investigators were not able to match for BRCA1/2 or other mutation status. When all matched patients were included, disease-specific survival (DSS) and OS were significantly lower in women who underwent unilateral mastectomy compared with CPM. For DSS, the hazard ratio (HR) was 0.83 (95% CI, 0.77 to 0.90); for OS, it was 0.77 (95% CI, 0.73 to 0.82). Presumably, CPM would increase survival by lowering the risk of CBC. The authors conducted another analysis excluding women diagnosed with CBC; the remaining sample was still large (25,924 women with unilateral mastectomy and 26,299 women with CPM). In the analysis excluding women with CBC, DSS and OS remained significantly lower in women who had unilateral mastectomy versus CPM. For DSS, the HR was 0.87 (95% CI, 0.80 to 0.94); for OS, it was 0.76 (95% CI, 0.71 to 0.81). The investigators suggested that the survival benefits found in CBC patients was not due to prevention of CBC, but instead to selection bias (e.g., healthier women choosing CBC). A limitation of the analysis was the inability to control for risk factors including gene mutation status, family history, and a history of radiotherapy to the chest between ages 10 and 30 years.

In 2013, Yao et al. evaluated OS 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 investigators did not report risk factors such as known genetic mutations. The 5-year OS rate was 80%. In an analysis adjusting for confounding factors, the risk of death was significantly lower in women who had CPM than in women who did not. The adjusted HR for OS was 0.88 (95% 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, there was a survival benefit after CPM for individuals ages 18 to 49 years and aged 50 to 69 years, but not for those 70 years or older. There was also a survival benefit for women with stage I and II tumors, but not stage III tumors.

A subsequent study by Pesce et al., published in 2014, focused on the subgroup of patients who were young (<45 years old) with stage I or II breast cancer. (12) A total of 4338 (29.7%) of 14,627 women in this subgroup had CPM at the time of mastectomy surgery. Median follow-up was 6.1 years. In a multivariate analysis controlling for potentially confounding factors, OS did not differ significantly among patients who underwent unilateral mastectomy and those who also had CPM (HR=0.93; 95% CI, 0.79 to 1.09). Moreover, among women younger than 45 years with estrogen receptor?negative cancer, there was no significant improvement in OS in those who had CPM versus unilateral mastectomy (HR=1.13; 95% CI, 0.90 to 1.42).

There are risks and benefits associated with CPM. In particular, several analyses have found higher rates of surgical complications in women undergoing CPM (bilateral mastectomy) versus unilateral mastectomy. Besides morbidity associated with these complications, surgical complications may delay receiving adjuvant therapy.

In 2015, Silva et al. published a large multicenter study including 20,501 women with unilateral breast cancer from the American College of Surgeons National Surgery Quality Improvement Program (NSQIP) database. (13) A total of 13,268 (64.7%) women underwent unilateral mastectomy and 7233 (35.3%) had bilateral mastectomy. The analysis did not report on high-risk factors such as BRCA mutation status or family history. All women had breast reconstruction; a higher proportion of women who had unilateral mastectomy (19.5%) than bilateral mastectomy (8.9%) had autologous reconstruction; the remainder had implant-based reconstruction. The authors conducted analyses controlling for confounding variables (i.e., age, race smoking, diabetes, chronic pulmonary disease, and hypertension) and stratifying by type of implant. The rate of overall complications was significantly higher for women who had a bilateral versus unilateral mastectomy, regardless of reconstruction type. Among women with implant reconstructions, overall complication rates were 10.1% after bilateral mastectomy and 8.8% after unilateral mastectomy (adjusted odd ratio [OR], 1.20; 95% CI, 1.08 to 1.33). In women with autologous reconstructions, overall complication rates were 21.2% after bilateral mastectomy and 14.7% after unilateral mastectomy (adjusted OR=1.60; 95% CI, 1.28 to 1.99). The most common complication was reoperation within 30 days, followed by surgical site complications. Transfusion rates were also significantly higher (p<0.001) in women with bilateral versus unilateral mastectomies who had either type of reconstruction. The rates of medical complications were relatively low -- approximately 1% of women who had implant reconstructions and 3% of women who had autologous reconstructions experienced a medical complication (i.e., pneumonia, renal insufficiency or failure, sepsis, urinary tract infection, venous thromboembolism) -- and did not differ significantly for unilateral versus bilateral mastectomies.

Several single-center studies have also found significantly higher surgical complication rates after bilateral than unilateral mastectomy. For example, in a 2013 study by Miller et al., which included 600 women with unilateral breast cancer, CPM remained associated with a significantly higher risk of any complication (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) than unilateral mastectomy. (14) Moreover, in a 2014 study by Eck et al., which assessed 352 women with unilateral breast cancer, 94 (27%) women had complications, 48 (14%) in the unilateral mastectomy group and 46 (13%) in the bilateral mastectomy group. (15) The difference between groups was not statistically significant (p=0.11), but this study may have been underpowered. Moreover, the Eck study found a significant delay in adjuvant therapy after surgical complications. Women with complications waited longer before receiving adjuvant therapy than those without complications (49 days vs 40 days, p<0.001).

Section Summary: CPM

Large observational studies have had mixed findings on the survival benefit of CPM in women with unilateral breast cancer who do not otherwise meet high-risk criteria. Researchers have suggested that improvement in survival after CPM in the general breast cancer population found in some studies is due at least in part to selection bias. Moreover, there are risks (e.g., surgical risks) of CPM. Setting aside selection bias, the patients experienced an increased survival following CPM.

Ongoing and Unpublished Clinical Trials

A search of ClinicalTrials.gov in January 2016 did not identify any ongoing or unpublished trials that would likely influence this review.

Clinical Input Received through Physician Specialty Societies and Academic Medical Centers

In 2010, Blue Cross Blue Shield Association requested and received clinical input from 6 academic medical centers and 1 specialty society while their policy was under review in 2010. The focused clinical input addressed the issue of CPM in women with unilateral breast cancer who are not otherwise at high-risk for developing breast cancer in the contralateral breast. Clinical input was mixed. Clinicians offered suggestions for modifying high-risk criteria but there was no consensus on potential additional risk factors. Input was in general agreement with the coverage statements considering testing for genomic rearrangements of BRCA1 and BRCA2 as medically necessary and with adding fallopian tube and primary peritoneal cancer as additional BRCA-associated malignancies to assess when obtaining the family history.

Practice Guidelines and Position Statements

National Comprehensive Cancer Network (NCCN)

The NCCN addresses PM within 2 guidelines:

Breast Cancer Risk Reduction (v.2.2016): “Risk-reduction mastectomy should generally be considered only in women with a genetic mutation conferring a high risk history for breast cancer), compelling family history, or possibly with LCIS [lobular carcinoma in situs] or prior thoracic radiation therapy at < 30 years of age. The value of risk-reduction mastectomy in women with deleterious mutations in other genes associated with a 2-fold or greater risk for breast cancer (based on large epidemiologic studies) in the absence of a compelling family history of breast cancer is unknown.” (3)

Breast cancer (v.2.2015): Except for certain high-risk situations (noted in the risk reduction guideline previously discussed), CPM is discouraged. (17) The guideline states: “the small benefits from contralateral prophylactic mastectomy for women with unilateral breast cancer must be balanced with the risk of recurrent disease from the known ipsilateral breast cancer, psychological and social issues of bilateral mastectomy, and the risks of contralateral mastectomy. The use of a prophylactic mastectomy contralateral to a breast treated with breast-conserving therapy is very strongly discouraged.”

NOTE: The NCCN identifies genes that confer more than 20% risk of breast cancer include BRAC1, BRCA2, ATM, CDH1, CHEK2, PALB2, PTEN, STK11, and TP53. Refer to their guidelines for Genetic/Familial High-Risk Assessment: Breast and Ovarian, Table

on GENE-2 for additional information.

Society of Surgical Oncology (SSO)

The SSO developed a position statement on PM in 1993. The position statement was updated in 2007 and indicates bilateral PM is potentially indicated in patients with (18):

“Known BRCA 1/2 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 lobular carcinoma in situ [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.

National Cancer Institute (NCI)

The NCI issued a fact sheet in 2012 on surgery to reduce the risk of breast cancer. The fact sheet provided the following information: “Prophylactic surgery to remove both breasts (called bilateral prophylactic mastectomy) can reduce the risk of breast cancer in women who have a strong family history of breast and/or ovarian cancer, who have a deleterious (disease-causing) mutation in the BRCA1 gene or the BRCA2 gene, or who have certain breast cancer-associated mutations in other genes, such as TP53 and PTEN.” (19)

Summary of Evidence

The evidence for PM in women who have high-risk of breast cancer or extensive mammographic abnormalities precluding incision or biopsy includes a BCBSA TEC Assessment and systematic review of observational studies. Relevant outcomes are OS, DSS, 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 CPM in women who have unilateral breast cancer but are not otherwise at high-risk includes observational studies, in which the findings were mixed. Relevant outcomes are OS, DSS, functional outcomes, and treatment-related morbidity. A systematic review revealed a second breast cancer increased from the 5-year results to the 10-year review for patients with BRCA1 and BRCA2 mutation carrier. Earlier studies showed the risk of death was significantly lower in women who had CPM than in women who did not. Although, clinical input was mixed to perform CPM for those patients with a higher-risk for developing breast cancer in the contralateral breast, the encouraging evidence demonstrates and is sufficient to determine the effects of CPM on health outcomes for patients who have been diagnosed with breast cancer in the opposite breast.

Contract:

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coding:

CODING:

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.

CPT/HCPCS/ICD-9/ICD-10 Codes

The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

19303, 19304

HCPCS Codes

None

ICD-9 Diagnosis Codes

Refer to the ICD-9-CM manual

ICD-9 Procedure Codes

Refer to the ICD-9-CM manual

ICD-10 Diagnosis Codes

Refer to the ICD-10-CM manual

ICD-10 Procedure Codes

Refer to the ICD-10-CM manual


Medicare Coverage:

The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does not have a national Medicare coverage position. Coverage may be subject to local carrier discretion.

A national coverage position for Medicare may have been developed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.

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

2. Bilateral Prophylactic Mastectomy in Women with an Increased Risk of Breast Cancer. Chicago, Illinois: Blue Cross Blue Shield Association Technology Evaluation Center Assessment Program (1999 August) 14(14):1-31.

3. NCCN – Breast Cancer Risk Reduction. V.1.2016. National Comprehensive Cancer Network. Available at: <http://www.nccn.org> (accessed on 2016 June 6).

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):1051-6, 58. 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):1564-9. 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):721-42. 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):1000-10. 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):3448-56. 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):389-96. 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):3231-9. 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):3474-80. 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):4113-20. 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):3297-303. PMID 25047470

16. NCCN – Genetic/Familial High-Risk Assessment: Breast and Ovarian. V.2.2016. National Comprehensive Cancer Network. Available at: <http://www.nccn.org> (accessed on 2016 June 6).

17. NCCN – Breast Cancer V.2.2016. National Comprehensive Cancer Network. Breast Cancer. Available at: <http://www.nccn.org> (accessed on 2016 June 6).

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. Mar 2007; 14(9):2425-7. PMID 17597344

19. NCI – Fact Sheet: Surgery to Reduce the Risk of Breast Cancer (2016 March 2) National Cancer Institute, National Institutes of Health. Available at <http://www.cancer.gov> (accessed on 2016 June 6).

20. ECRI Institute. Prophylactic oophorectomy and mastectomy for BRCA genetic mutation carriers. Plymouth Meeting (PA): ECRI Institute; 2013 Jun. 14 p. (Hotline Response).

21. Prophylactic Mastectomy. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2016 February) Surgery: 7.01.09.

Policy History:

Date Reason
11/15/2017 Reviewed. No changes.
2/1/2017 Document updated with literature review. The following was changed in the coverage statement for prophylactic mastectomy: 1) The separate medically necessary statement on lobular carcinoma in situ removed and added to the coverage criteria listing for patients at high-risk; 2) The wording “Another gene mutation associated with high-risk, e.g.,” was added to the criterion of specific mutations as a clarification of these types of mutations; and, 3) A revision in the same coverage statement from ““20% to 25%” changed to “20%”. “Tyrer-Cuzick” scoring model was added to the listing of Calculation of Breast Cancer Risk Assessment Tools. Otherwise, coverage unchanged
8/15/2015 Document updated with literature review. The following mutations were added to the medically necessary coverage statement for prophylactic mastectomy for patients considered to be high-risk for breast cancer, “PTEN, TP53, CDH1, and STK11.” Experimental, Investigational, and/or Unproven statement regarding contralateral PM (CPM) in women with breast cancer who do not meet high-risk criteria has been removed, and replaced with Contralateral PM (CPM) may be considered medically necessary for women who have been diagnosed with breast cancer in the opposite breast.
7/1/2014 Document updated with literature review. Coverage unchanged. Link information for online addresses provided in coverage section to assist in calculation of breast cancer risk assessment. Rationale and References updated.
3/1/2014 Document updated with literature review. The following was changed: 1.) Prophylactic mastectomy (PM) may be considered medically necessary in patients at high-risk of breast cancer when specific criteria have been met; 2.) PM may be considered medically necessary in patients with lobular carcinoma in situ (LCIS); 3.) PM may be considered medically necessary in patients with such extensive mammographic abnormalities (i.e., calcifications) that adequate biopsy or excision is impossible; and 4.) PM is considered experimental, investigational or unproven for all other indications, including but not limited to contralateral PM in women with breast cancer who do not meet high-risk criteria, unilateral or bilateral PM in women at moderate-risk of breast cancer, and uncontrolled progress of inflammatory breast disease in one or both breasts (i.e., chronic mastitis, macrocystic or fibrocystic disease). Title changed from Breast Surgery for Prophylaxis or Cancer Prevention. Description, Rationale, and References completely revised.
7/1/2008 Policy reviewed without literature review; new review date only.
6/1/2005 Revised/updated entire document
8/1/2003 Revised/updated entire document
8/1/1999 Rationale revised
2/1/1999 Medical policy title changed
5/1/1996 Medical policy number changed. Revised/updated entire document
1/1/1996 Revised/Updated Entire MP. Medical policy title changed
7/1/1992 Revised/Updated Entire MP
3/1/1991 Revised/Updated Entire MP
5/1/1990 New medical document

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