If you don't remember your password, you can reset it by entering your email address and clicking the Reset Password button. You will then receive an email that contains a secure link for resetting your password
If the address matches a valid account an email will be sent to __email__ with instructions for resetting your password
Division of Plastic Surgery, Department of Surgery, University of Maryland School of Medicine, Baltimore, MDDepartment of Plastic and Reconstructive Surgery, Johns Hopkins University, Baltimore, MD
Division of Plastic Surgery, Department of Surgery, University of Maryland School of Medicine, Baltimore, MDDivision of Plastic and Reconstructive Surgery, University of Miami Miller School of Medicine, Miami, FL
A patient’s access to private medical insurance can be a predictive factor in the likelihood to receive a Prophylactic Mastectomy (PM).
•
Significant variability in insurance coverage between companies can lead to further inequalities in access to this procedure. The authors have previously discussed the variability in coverage of contralateral prophylactic mastectomies in the setting of a breast cancer diagnosis.
•
In this study, the authors evaluate the current landscape of insurance coverage for bilateral or contralateral prophylactic mastectomies in noncancerous or “high-risk” patients. Preauthorized coverage of PMs was provided by 39% of insurance policies (n = 39). While there was consensus amongst these policies to cover a PM for BRCA1/2 mutations (n = 39, 100%), other indications had more variable coverage such as previous radiotherapy (92%), pathological changes in the breast (3%-92%), personal history of cancer (64%) and family history risk factors (39%-51%).
•
This study highlights the influence that insurance companies may have in this life-altering choice. Physicians and patients alike should advocate for fair and equal access to PM for certain clinical indications.
Abstract
Background
Breast cancer is associated with a multitude of risk factors, such as genetic predisposition and mutations, family history, personal medical history, or previous radiotherapy. A prophylactic mastectomy (PM) may be considered a suitable risk-reducing procedure in some cases. However, there are significant discrepancies between national society recommendations and insurance company requirements for PM.
Materials and Methods
The authors conducted a cross-sectional analysis of insurance policies for a PM. One-hundred companies were selected based on the greatest state enrolment and market share. Their policies were identified through a Web-based search and telephone interviews, and their medical necessity criteria were extracted.
Results
Preauthorized coverage of PMs was provided by 39% of insurance policies (n = 39) and 5 indications were identified. There was consensus amongst these policies to cover a PM for BRCA1/2 mutations (n = 39, 100%), but was more variable for other genetic mutations (15%-90%). Coverage of PM for the remaining indications varied among insurers: previous radiotherapy (92%), pathological changes in the breast (3%-92%), personal history of cancer (64%) and family history risk factors (39%-51%).
Conclusion
There is a marked level of variability in both the indications and medical necessity criteria for PM insurance policies. The decision to undergo a PM must be carefully considered with a patient's care team and should not be affected by insurance coverage status.
A multitude of risk factors are associated with the development of breast cancer, including: genetic predisposition and susceptibility, family history, personal medical history, exogenous hormone intake, lifestyle patterns, and anthropomorphic characteristics.
Moorthie S, Gaynor L, Burton H, Hall A, Kroese M, Raza S. Personalised prevention in breast cancer the policy landscape 2 personalised prevention in breast cancer: the policy landscape. Accessed 13 November 2020. Available at:www.b-cast.eu; 2017.
Due to its mortality and predictive risk factors, there has been a growing global initiative for the early detection and prevention of breast cancer,
Moorthie S, Gaynor L, Burton H, Hall A, Kroese M, Raza S. Personalised prevention in breast cancer the policy landscape 2 personalised prevention in breast cancer: the policy landscape. Accessed 13 November 2020. Available at:www.b-cast.eu; 2017.
However, the definition of “high-risk” can be difficult, multifaceted, and require a considered discussion between a patient and their health care team. This is evident in a statement by the Society of Surgical Oncology (SSO), who attempted to outline the indications in which a PM may be considered.
with common themes between the 2 societies (Table 1). Furthermore, a patient's comorbidities, socioeconomic background, and insurance coverage also play a role in the decision for a PM.
Despite this, there is often a significant variability between insurance coverage that can lead to inequalities in the access to procedures, and limits even their discussion of medical necessity.
Previously, the authors have discussed the variability in coverage of contralateral prophylactic mastectomies in the setting of a breast cancer diagnosis.
However, the literature is void on the insurance coverage for bilateral or contralateral prophylactic mastectomies noncancerous “high-risk” indications.
Table 1Recommended Indications for Prophylactic Mastectomies by SSO,
Multiple modifiable and nonmodifiable factors that contribute a small increase in relative risk individually (1.5-2.0), such as bone mineral density, alcohol consumption, circulating insulin and oestrogen levels.
Fibrocystic breast disease
Personal history of malignant neoplasm of breast
Abbreviations: ASBrS = American Society of Breast Surgeons; ASPS = American Society of Plastic Surgery; SSO = Society of Surgical Oncology.
a Contralateral prophylactic mastectomy is discouraged in average-risk women with unilateral breast cancer
b Multiple modifiable and nonmodifiable factors that contribute a small increase in relative risk individually (1.5-2.0), such as bone mineral density, alcohol consumption, circulating insulin and oestrogen levels.
This study aims to assess the insurance coverage for PM in patients without diagnosed breast cancer, and the variability in indications and medical necessity criteria. We will also compare whether insurance policies’ definition of high-risk patients reflects national recommendations of SSO, ASBrS, and ASPS.
Material and Methods
We selected the 100 largest and most popular third-party payers in America, including Medicare and Medicaid. This was based on state enrolment and company market share, as reported by the Henry Kaiser Foundation and National Association of Insurance Commissioners.
National Association of Insurance Commissioners. 2017 market share reports for the top 125 accident and health insurance groups and companies by state and countrywide. Accessed 15 November 2020. Available at:https://www.naic.org/prod_serv/MSR-HB-18.pdf
A web-based search was conducted to identify the policies related to prophylactic mastectomies from the corresponding company's website. If a policy was not available online, we communicated with the company directly via telephone call or email, and if a lack of established criteria for surgical intervention was confirmed, the insurance company was deemed not to have a policy for PM surgery. Policies were categorized into 3 groups based on coverage status: never covered, covered on a case-by-case basis, and covered with pre-authorization. Case-by-case status was defined as a policy established for coverage but without standardized criteria for determining medical necessity and coverage determined only with specific patient details.
The insurance policies with medical necessity criteria were analyzed and compared to the recommendations from SSO
The coverage eligibility criteria were extracted and divided into 5 indications based on SSO, ASBrS, and ASPS recommendations: genetic susceptibility, familial history, irradiation history, personal history of malignant neoplasm, and pathological changes in the breast (Table 1). Family history was categorized into 2 groups based on the guideline that defined them. The first is by ASPS and includes specific scenarios in which a PM would be covered, such as “a first degree relative with bilateral breast cancer” or “3 or more second/third degree relatives with breast cancer.”. In contrast, the second group encompasses nonspecific criteria in which a patient had to demonstrate a significant breast cancer risk from multiple factors including their family history. This is more reflective of SSO's discussion of family history. Family history is not included in ASBrS recommendations.
Data were compiled and analyzed in Microsoft Excel (Microsoft Corp., Redmond, WA). Categorical variables were compared using chi-squared test and Fisher's exact test, as appropriate. Statistical significance was defined as P less than or equal to .05.
Results
Coverage
One hundred insurance companies were evaluated for the coverage of bilateral or contralateral prophylactic mastectomies for noncancerous indications, including Medicare and Medicaid (Figure 1), where just under half possessed an established policy for PM (44%, n = 44). Most of these policies provided preauthorized coverage (87%, n = 39), whereas 5 (13%) covered on a case-by-case basis. Of the remaining 56 companies who did not possess an established policy, 21 (38%) companies recommended a PM in their genetic screening policy but did not hold a specific PM policy.
Genetic Susceptibility
Consistent with SSO, ASBrS, and ASPS recommendations, genetic mutations were covered by all preauthorized policies. Seven mutations were included in policies for the indication of genetic susceptibility (Figure 2). All policies provided PM coverage for patients with a BRCA1 or BRCA2 mutation (100%, n = 39), and a further 6 companies also provided coverage if the mutation was found in an immediate family member (15%). However, 6 (15%) of the policies required confirmation of the high-risk mutation by molecular susceptibility.
Figure 1Insurance coverage of prophylactic mastectomies.
Certain policies also considered the presence of genetic mutations in family members. For 2 (5%) policies that addressed BRCA1/2 mutations, PM would only be covered if the policy holder's mutation matched a family member's mutation and the family member had an active diagnosis of breast cancer. In addition, 7 insurance policies (18%) also provided coverage if a mutation was present as a syndrome in a first-degree family member: Li-Fraumeni syndrome (TP53 mutation), Cowden syndrome (PTEN mutation), or Bannayan-Riley-Ruvalcaba syndrome (PTEN mutation).
Familial History
Of insurers with an established policy, 37 (95%) provided coverage in the case of a positive family history of breast cancer. ASPS's family history criterion requirements were present in 20 insurance policies (51%), with each criterion summarized in Table 2. SSO's family history criterion was present in 39% of policies (n = 15) and was often proven with a separate risk assessment tool of the provider's choosing, such as the Gail or Claus model, that demonstrated a >20% lifetime risk of developing breast cancer (87%, n = 13) (Table 3). Of those who did not have general family history as a criterion, a further 7 companies (18%) stated they may consider those with an SSO's definition of family history criteria on a case-by-case basis.
Table 2Required Criteria for Specific Family History
Reason for Coverage
Number of Companies (n = 39)
Specific family history criteria
20 (51%)
1st degree relative with cancer
A 1st degree relative with bilateral breast cancer
8 (21%)
A 1st degree relative with breast cancer <50 yo
2 (5%)
A 1st degree relative with breast cancer <45 yo AND another relative with breast cancer
8 (21%)
A 1st degree relative with breast cancer AND another relative with ovarian cancer
7 (18%)
A 1st degree relative with breast cancer AND multiple 2nd/3rd relative with breast cancer
8 (21%)
Multiple 1st degree relatives with breast cancer
7 (18%)
Multiple 1st degree relatives with breast cancer OR ovarian cancer
2 (5%)
1st or 2nd degree relative with cancer
A 1st/2nd degree relative with multiple primary breast cancers
10 (26%)
A 1st/2nd degree relative with bilateral breast cancers
9 (23%)
3 or more 1st/2nd degree relatives on the same side with breast cancer
9 (23%)
2nd or 3rd degree relative with cancer
A 2nd/3rd degree relative with breast cancer AND multiple relatives of any degree with ovarian cancer
6 (15%)
Multiple 2nd/3rd degree relatives with breast cancer AND a relative of any degree with ovarian cancer
6 (15%)
Three or more 2nd/3rd degree relatives with breast cancer
7 (18%)
Other
A 1st degree relative with breast cancer <45yo AND another relative with ovarian cancer
1 (3%)
A relative of any degree with breast cancer AND 2 additional relatives on that side with breast cancer OR ovarian cancer
1 (3%)
A 1st degree relative with breast cancer OR ovarian cancer OR prostate cancer
1 (3%)
Multiple successive generations with breast/ovarian/fallopian tube/prostate/pancreatic/peritoneal cancer
1 (3%)
A 1st degree relative with premenopausal bilateral breast cancer
1 (3%)
Multiple relatives on the same side with cancer, with at least 1 <50yo
1 (3%)
A 1st/2nd degree relative <45yo with breast cancer
1 (3%)
A 1st/2nd degree relative with breast cancer AND a 1st/2nd degree relative with ovarian cancer
1 (3%)
A 1st degree relative with ovarian/fallopian tube/peritoneal cancer AND a 1st/2nd degree relative with breast cancer
1 (3%)
A 1st degree relative with ovarian/fallopian tube/peritoneal cancer AND multiple 3rd degree relatives with breast cancer
Radiation history was defined as any previous radiotherapy for any indication, such as pediatric lymphomas. A history of radiation therapy to the chest, a marker of high-risk patients as recommended by SSO, was an approved indication for PM in 92% of policies (n = 36). In all cases, coverage of PM was dependent on the age of the patient at the time of radiation therapy (Figure 3), with 3 quarters of policies covering if radiation was given between 10 and 30 years old (78%, n = 28).
Figure 3Medical necessity criteria for the indication of previous radiotherapy.
Indications for PM based on past malignancy history are summarized in Table 4. For the criteria of a personal, previous history of female breast cancer, a PM for the contralateral breast was authorized in 64% (n = 25) of policies. Whereas in the criteria of ovarian cancer, significantly fewer companies covered a PM compared to previous breast cancer (18% vs. 64%, n = 7, P < .001). Of those that did cover a PM in those with ovarian cancer, the majority also required a family history of 1 or more first/second degree relatives to have been diagnosed with breast cancer (86%, n = 6).
Table 4Required Medical Necessity Criteria for Personal Medical History of Cancer
Indication for a Prophylactic Mastectomy
Medical Necessity Criteria
Number of Companies (n = 39)
Personal history of malignant neoplasm
History of breast cancer
25 (64%)
History of ovarian cancer
7 (18%)
Carcinoma in situ of the breast
LCIS
36 (92%)
DCIS
2 (5%)
Neoplasm of uncertain behavior of the breast
Atypical hyperplasia
17 (44%)
Mammographic abnormalities not amenable to biopsy
26 (67%)
Fibrocystic breast disease
Symptomatic and unresponsive to conservative treatment
1 (3%)
Abbreviations: DCIS = ductal carcinoma in situ; LCIS = lobular carcinoma in situ.
Pathological changes in the breast can describe carcinoma in situ, atypical hyperplasia, mammographic abnormalities of dense breasts, or fibrocystic disease. There are 2 forms of carcinoma in situ of the breast: ductal carcinoma-in-situ (DCIS), a type of breast malignancy, or lobular carcinoma in situ (LCIS), a high risk, nonmalignant lesion. For LCIS, coverage for a PM was provided in most cases (92%, n = 36), where 7 policies (19%) specifically required the diagnosis to be made on biopsy. In contrast, significantly fewer insurance companies provided a preauthorized PM in the setting of DCIS compared to LCIS (n = 2, 6% vs. 92%, P < .001) (Table 4).
For atypical hyperplasia, coverage for a PM was provided in 44 % of policies (n = 17). One third-party payer, coverage was explicitly denied in the setting of atypical hyperplasia (3%, Geisinger). In settings where lesions could not be biopsied, for example, proximity to skin or chest wall, a PM was covered in two-thirds of the policies (67%, n = 26) (Table 4). Finally, 7 (17%) insurance companies discussed fibrocystic breast disease; the majority (n = 6) denied coverage for a PM Whereas 1 company provided coverage only if the patient was symptomatic and unresponsive to conservative treatment. PM was denied in 5 other specific breast diseases (Table 5).
Table 5Denied Indications for Prophylactic Mastectomy
Denied Indication
Number of Companies (n = 39)
Atypical hyperplasia
1 (3%)
Fibrocystic breast disease
6 (15%)
Diabetic mastopathy
3 (8%)
Pseudoangiomatous stromal hyperplasia (PASH)
3 (8%)
Uncontrolled inflammatory breast disease (ie, chronic mastitis or macrocystic disease)
Our data clearly demonstrates the variability in insurance coverage, indications, and medical necessity criteria for a PM. We report a low proportion of insurers (44%) held a clear and publicly available policy for a PM. The benefit of prophylactic mastectomies in reducing breast cancer risk must be taken with great consideration, and for those of significantly high risk.
However, the definition of “high risk” is inconsistent among national recommendations and insurance policies. Only 1 medical criterion was universally addressed by the PM policies (BRCA1/2 mutation for genetic susceptibility). Additionally, the definition of family history differed depending on either the ASPS or the SSO definition. Only 1 in 10 policies addressed both possible criteria for family history. If we are to address the complex decision for a PM, we require greater availability and flexibility in policies of US insurance companies.
We report that genetic mutations were covered by all preauthorized policies. This universal coverage reflects the global agreement between SSO, ASBrS, and ASPS; these societies advocate for PM in patients with genetic susceptibility. Patients with a BRCA1 or BRCA2 mutation have a 60% to 90% lifetime risk of developing breast cancer
Nonetheless, since the discovery of the association between BRCA genes and breast cancer, numerous other genes have also come to light to potentially increasing lifetime risk of breast cancer.
and is reflected in 54% of approval policies. When reflecting on the array of genetic results which may confer an increased breast cancer risk, the National Comprehensive Cancer Network (NCCN) has compiled a comprehensive review of their management.
NCCN guidelines insights: genetic/familial high-risk assessment: breast, ovarian, and pancreatic, version 1.2020: featured updates to the NCCN guidelines.
Even in higher risk genes, such as TP53, PTEN, and even BRCA1/2, PMs should only be discussed in comprehensive counselling, and considered with other risk-reducing options such a regular screening and chemoprevention.
NCCN guidelines insights: genetic/familial high-risk assessment: breast, ovarian, and pancreatic, version 1.2020: featured updates to the NCCN guidelines.
We also report significant variability in the assessment of family history between the insurance policies, with multiple potential definitions of a high-risk family history. For those that reflect the ASPS definition of family history criteria, the source of these criteria appears inconsistent. One potential source is a set of criteria created by Hartmann et al.
, who produced a retrospective study highlighting the efficacy of PMs in their population. This outlines 8 specific criteria that may classify a patient as high-risk (Table 6), and this was the most adopted framework from our cohort of polices. However, this still only represented 16% of those who assessed family history. The remaining policies took an amalgamated approach to their selection criteria, with little overlap or consistency between them, which in turn may cause more confusion than clarity for the patient.
Table 6High-Risk Criteria for Recommendation of a Prophylactic Mastectomy by Hartmann et al
Though the scientific reasoning for ASPS's definition of familial history is vague, the current literature to support SSO's definition is much more concrete. This is where familial risk may not be best defined by a single situation, but rather a more global assessment of cancer risk is required, 1 that is supported by NCCN guidelines as well.
NCCN guidelines insights: genetic/familial high-risk assessment: breast, ovarian, and pancreatic, version 1.2020: featured updates to the NCCN guidelines.
NICE Guidelines Familial breast cancer: classification, care and managing breast cancer and related risks in people with a family history of breast cancer.
Moorthie S, Gaynor L, Burton H, Hall A, Kroese M, Raza S. Personalised prevention in breast cancer the policy landscape 2 personalised prevention in breast cancer: the policy landscape. Accessed 13 November 2020. Available at:www.b-cast.eu; 2017.
However, these come with their own drawbacks. Many are situation-specific or based on a subset of the population that cannot be generalized to the public. For example, the Gail model was based off an entirely white-Caucasian cohort. Since then, newer models have been produced to be more representative of the population, but they require more rigorous evaluation.
Moorthie S, Gaynor L, Burton H, Hall A, Kroese M, Raza S. Personalised prevention in breast cancer the policy landscape 2 personalised prevention in breast cancer: the policy landscape. Accessed 13 November 2020. Available at:www.b-cast.eu; 2017.
Thus, with so many potential assessments of familial risk, we require greater flexibility of options within our insurance criteria, as opposed to inconsistent limitations.
The use of external radiation is another risk factor for the development of breast cancer,
Thus, it is unsurprising that almost all insurance policies included prior radiation as a covered indication for PM. Additionally, the national societies (SSO, ASBrS, and ASPS) recommend PM in the setting of previous radiation.
There is a significant increased risk in breast malignancy if the radiation was received earlier than age 30, with the risk highest if received at an early age. However, the majority of insurers required the prior radiotherapy to have occurred between the ages 10 and 30. These age restrictions may create unnecessary barriers for patients who may want to discuss a PM as a potential risk-reducing method for breast cancer.
Almost two-thirds of insurance companies surveyed would cover a contralateral mastectomy if there was a personal history of cancer. Contralateral PM is commonly considered in patients with an existing diagnosis of unilateral breast cancer. Since their initial use in BRCA positive patients, there was an increase in breast cancer patients requesting a PM in the contralateral nonaffected breast, with the aim to reduce the incidence of contralateral breast cancer.
However, the utility of PMs in this patient cohort has been debated, as without a significant familial history or high risk diagnosis (such as diagnosed <45 years old or bilateral breast cancer), the patient may not have an increase in life expectancy afterwards.
In fact, ASBrS recommends PM in high risk but unaffected patients but discourages contralateral PM in those without increased risk and unilateral breast cancer. This discordance between national recommendations may account for the observed variability in insurance coverage.
Although it is unclear whether breast cancer alone is indicative of an increased risk of contralateral breast cancer, some benign breast disease can act as high-risk lesions in the affected breast. LCIS, atypical hyperplasia and high mammographic breast density have each shown to be independent risk factors for developing breast cancer.
there is growing support that similar levels of risk-reduction can be achieved with high risk screening and potential chemoprevention, such as via tamoxifen.
NCCN guidelines insights: genetic/familial high-risk assessment: breast, ovarian, and pancreatic, version 1.2020: featured updates to the NCCN guidelines.
Strikingly, significantly fewer companies covered PM in the setting of DCIS compared to LCIS. It is possible that DCIS is included in the definition of personal history of malignant neoplasm and patients receive coverage for PM via this avenue. In the case of fibrocystic disease, it does not possess the same significant increased risk of breast cancer, and thus, a PM is explicitly not recommended.
Although suggested as an indication by ASPS, it is largely not accounted for by insurance companies, and when it is, it is typically denied. Thus, for noncancerous breast disease, the utility of a PM must be taken with care and with a multidisciplinary specialist team to consider the wider literature on their benefits.
The limitations of this article lie in its cross-sectional nature. Due to the wide variety of medical plans and the ongoing updates to them, the data and recommendations may not be applicable to all cases. As the lack of accessible policy and case-by-case scenarios are assessed on an individual basis, our estimations could be over- or under-representative of true insurance coverage. This article also assesses the ease of which a patient can access coverage for a PM, but does not address the complex, multifaceted decision making required to decide if a PM is the most appropriate course of action. However, that conversation cannot begin if there is no PM insurance policy, or it is denied in the first place. Further studies could assess how well patients are able to access the tools required to fulfil the pre-requisite criteria, such as genetic testing. Nonetheless, the strength in out paper lies in the large number of companies assessed, and how the authors are the first to thoroughly assess and categorizes the complex criteria required from third-party payers for a PM.
Conclusion
In this paper, we have provided a comprehensive report of the variety of indications and criteria required for a PM. There is a marked level of variability in the insurance policies of prophylactic mastectomies, in both their indications and medical necessity criteria. The decision to undergo a PM must be carefully considered with a patient's caring team, and not be affected by the coverage of their insurers. As a PM is a sensitive, complex decision-making process, we highlight the different influences insurance companies may have in this life-altering choice.
Clinical Practice Points
•
A patient's access to private medical insurance can be a predictive factor in the likelihood to receive a Prophylactic Mastectomy (PM).
•
Significant variability in insurance coverage between companies can lead to further inequalities in access to this procedure. The authors have previously discussed the variability in coverage of contralateral prophylactic mastectomies in the setting of a breast cancer diagnosis.
•
In this study, the authors evaluate the current landscape of insurance coverage for bilateral or contralateral prophylactic mastectomies in noncancerous or “high-risk” patients. Preauthorized coverage of PMs was provided by 39% of insurance policies (n = 39). While there was consensus amongst these policies to cover a PM for BRCA1/2 mutations (n = 39, 100%), other indications had more variable coverage such as previous radiotherapy (92%), pathological changes in the breast (3%–92%), personal history of cancer (64%) and family history risk factors (39%–51%).
•
This study highlights the influence that insurance companies may have in this life-altering choice. Physicians and patients alike should advocate for fair and equal access to PM for certain clinical indications.
Disclosure
The authors have stated that they have no conflicts of interest.
Human Studies and Subjects
Not applicable.
Acknowledgments
This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.
References
National Cancer Institute. Surveillance, Epidemiology, and End Results Program. Accessed 12 November 2020. Available at:https://seer.cancer.gov/
Moorthie S, Gaynor L, Burton H, Hall A, Kroese M, Raza S. Personalised prevention in breast cancer the policy landscape 2 personalised prevention in breast cancer: the policy landscape. Accessed 13 November 2020. Available at:www.b-cast.eu; 2017.
National Association of Insurance Commissioners. 2017 market share reports for the top 125 accident and health insurance groups and companies by state and countrywide. Accessed 15 November 2020. Available at:https://www.naic.org/prod_serv/MSR-HB-18.pdf
NCCN guidelines insights: genetic/familial high-risk assessment: breast, ovarian, and pancreatic, version 1.2020: featured updates to the NCCN guidelines.
00269-5&id=gr1.jpg){kind=link}
00269-5&id=gr2.jpg){kind=link}
00269-5&id=gr3.jpg){kind=link}