Current National Health Insurance Coverage Policies ... - Springer Link

Annals of Surgical Oncology, 7(5):325–332 Published by Lippincott Williams & Wilkins © 2000 The Society of Surgical Oncology, Inc.

Current National Health Insurance Coverage Policies for Breast and Ovarian Cancer Prophylactic Surgery Henry M. Kuerer, MD, PhD, E. Shelley Hwang, MD, James P. Anthony, MD, R. Adams Dudley, MD, MBA, Beth Crawford, MS, Wade M. Aubry, MD, and Laura J. Esserman, MD, MBA

Background: The efficacy of prophylactic mastectomy and oophorectomy in reducing breast and ovarian carcinoma has recently been reported in high-risk women. Because cost has become central to medical decision-making, this study was designed to evaluate currently existing coverage policies for these procedures. Methods: A confidential detailed cross-sectional nationwide survey of 481 medical directors from the American Association of Health Plans, Medicare, and Medicaid was conducted. Results: Of the 150 respondents, 65% (n ⫽ 97) had 100,000 or more enrolled members and 35% (n ⫽ 53) had fewer than 100,000 enrolled members. Only 44% of private plans have specific policies for coverage of prophylactic mastectomy for a strong family history of breast cancer and 38% of plans for a BRCA mutation. Only 20% of total responding plans had a policy for coverage of prophylactic oophorectomy under any clinical circumstance. Governmental carriers were significantly less likely to have any policy for prophylactic surgery (range, 2%–12%) compared with nongovernmental plans (range, 24%– 44%; P ⬍ .001). No significant regional differences for coverage policies were identified (P ⬎ .05). Conclusions: Significant variations currently exist for health insurance coverage of prophylactic mastectomy and oophorectomy. As genetic testing becomes widespread, more uniform policies should be established to enable appropriate high-risk candidates equal access and coverage for these procedures. Key Words: Prophylactic surgery—BRCA1—BRCA2—Breast cancer—Ovarian cancer— Health insurance.

There are few interventions in medicine that provoke a greater emotional response in patients and their physicians than prophylactic mastectomy and oophorectomy. The optimal medical management necessary to maximize breast and ovarian cancer risk reduction remains to be clarified in women with significant family histories and genetic mutations for these malignancies. However,

the recent discovery of the BRCA 1 and 2 genes and the rapid introduction of clinical testing for mutations in these genes allow for the opportunity of early identification of extremely high-risk patients and the chance to intervene in an attempt to reduce their risk of cancer.1,2 Patients with these genetic mutations have an estimated absolute lifetime risk of developing breast cancer of 60% to 85% and of developing ovarian carcinoma of 15% to 40%.3–5 Although prophylactic mastectomy has been performed for several decades in an attempt to reduce breast cancer risk, the efficacy of this procedure has only recently been reported in a large cohort of high-risk women with long-term follow-up.6 Bilateral prophylactic oophorectomy has also been shown to reduce the frequency of ovarian carcinoma in women from families with inherited breast and ovarian cancer and may also

Received November 12, 1999; accepted January 21, 2000. From the Department of Surgery (HMK, ESH, JPA, LJE), Institute for Health Policy Studies (RAD, WMA), and the Cancer Risk Program (BC), University of California at San Francisco, San Francisco, California. Presented at the 53rd Annual Meeting of the Society of Surgical Oncology, New Orleans, Louisiana, March 16 –19, 2000. Address correspondence and reprint requests to: Henry M. Kuerer, MD, PhD, The University of Texas M. D. Anderson Cancer Center, Department of Surgical Oncology, 1515 Holcombe Boulevard, Houston, TX, 77030; Fax: 713-745-1921.

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reduce their chances of developing breast carcinoma.7,8 Although surgical prophylaxis does not completely eliminate the chances of developing breast and ovarian carcinoma in all high-risk women, it remains a potential option for substantially reducing the risk of breast and ovarian carcinoma. From the patients’ perspective, financial costs of these procedures may preclude consideration of prophylactic surgery as an option in reducing risk. During counseling of women with a hereditary risk of breast and ovarian cancer, it became apparent that some of our patients were being denied coverage for these procedures. We recently investigated the rate of occurrence of health insurance coverage for prophylactic mastectomy in women from the Northern California region and found that less than half of the insurance carriers of our patients had formal coverage policies for these procedures.9 Because cost has become central to decision-making for an increasing number of American women who may be considering prophylactic surgical procedures, financial factors are a pivotal issue for patients, health insurance carriers, and physicians. This study was designed to evaluate currently existing health insurance plans’ coverage policies for prophylactic surgery in women at high risk for breast and/or ovarian carcinoma from a nationwide sample of plans in the United States. MATERIALS AND METHODS Study Design and Population A confidential survey of health insurance plans was conducted between April 1999 and June 1999. The design of this study was partially based on published information about how U.S. health plans evaluate insurance coverage decisions for new medical technology.10 The study population included every fourth member plan of the American Association of Health Plans, Medicaid, and Medicare. There were 400 member companies included from the American Association of Health Plans, 31 part B Medicare carriers, and 50 state Medicaid offices. The Survey Instrument The Committee on Human Research and Institutional Review Board of the University of California San Francisco approved this study and survey instrument. Medical directors were asked to state the type of insurance company they represented, the approximate number of enrolled members and their states of residence, and whether the plan was for-profit or nonprofit. The survey contained a series of simple questions regarding coverage policy of prophylactic surgery for three groups of Ann Surg Oncol, Vol. 7, No. 5, 2000

patients, i.e., those with a known strong family history of breast or ovarian carcinoma, those with a BRCA mutation, and those with a concurrent diagnosis of breast cancer or atypical hyperplasia. Health insurance carrier respondents’ definitions of a strong family history of breast or ovarian carcinoma were based on their individual internal guidelines. If no coverage policy existed, the respondent was asked to state who had the final responsibility within the organization for making individual coverage or medical necessity decisions. Data Collection and Statistical Analysis Each survey was mailed with a personalized cover letter that explained the study with a stamped preaddressed return envelope. The surveys were sent by priority mail and the final response rate was determined in August 1999. Data were analyzed by using Statistica software (Statsoft, Tulsa, OK). For regional analysis of the responding health plans, the United States was divided into five regions, which included the Eastern region (CT, DE, ME, MD, MA, NH, NJ, NY, PA, RI, VT, and Washington, DC), the Southeastern region (AL, FL, GA, KY, NC, PR, SC, VA, and WV), the Midwestern region (IL, IN, IA, MI, MN, ND, OH, SD, and WI), the Southwestern region (AZ, AR, CO, KS, LA, MO, MS, NE, NM, OK, TN, and TX), and the Western region (AK, CA, Guam, HI, ID, MT, NV, OR, UT, WA, and WY). Differences in coverage policies for prophylactic surgery between health insurance carrier groups were assessed by ␹2 analysis. All comparisons were twotailed. The statistical significance level (P) was taken as a measure of the strength of evidence against the null hypothesis, and P ⱕ .05 was considered statistically significant. RESULTS Response Rate and Respondent Characteristics Table 1 shows the overall characteristics of the responding health plans. The overall response rate for this survey was 31% (n ⫽ 150) of the 481 questionnaires sent. The response rate was 25% for members of the American Association of Health Plans (n ⫽ 98), 65% for regional Medicare part B carriers (n ⫽ 20), and 62% for state Medicaid plans (n ⫽ 32). The results of this survey represent coverage policies for reported enrolled members from each of the 50 United States, Puerto Rico, Washington, DC, and Guam. Overall, 35% of plans (n ⫽ 52) identified themselves as for-profit carriers. Of the responding insurance plans, 65% (n ⫽ 97) had 100,000 or more enrolled members and 35% (n ⫽ 53) had fewer than 100,000 enrolled members.

U.S. HEALTH INSURANCE COVERAGE FOR CANCER PROPHYLACTIC SURGERY TABLE 1. Overall characteristics of 150 responding health insurance plans Characteristic

No. (%)

Type of health insurance plan HMO PPO Multiple insurance products Medicare Medicaid Profit status For profit Not for profit Size ⬍100,000 enrolled members ⱖ100,000 enrolled members Region within United Statesa Eastern Southwestern Midwestern Southwestern Western

37 (25) 14 (9) 47 (32) 20 (13) 32 (21) 52 (35) 98 (65) 53 (35) 97 (65) 28 (16) 34 (20) 32 (19) 41 (24) 37 (21)

HMO, health maintenance organization; PPO, preferred provider organization. a Nineteen respondents had enrolled members in one or more regions.

Of the 52 responding governmental plans (Medicare carriers and Medicaid programs), 50 respondents represented one region of the United States and 2 respondents represented 2 separate regions of the United States. The responding governmental carriers represented all regions from the United States. Twenty percent (n ⫽ 11) were from the Eastern region, 20% (n ⫽ 11) were from the Southeastern region, 17% (n ⫽ 9) from the Midwestern

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region, 19% (n ⫽ 10) from the Southwestern region, and 24% (n ⫽ 13) were from the Western region. Of the 98 responding nongovernmental plans, 38% (n ⫽ 37) reported to be a health maintenance organization, 14% (n ⫽ 14) reported to be a preferred provider organization, and 48% (n ⫽ 47) reported to represent multiple insurance products. Of the 98 responding nongovernmental plans, 83% (n ⫽ 81) represented enrolled members from one region in the United States, 14% (n ⫽ 14) from two regions in the United States, and 3% (n ⫽ 3) from three regions in the United States. Responding nongovernmental plans represented all regions within the United States. Fourteen percent (n ⫽ 17) were from the Eastern region, 20% (n ⫽ 23) were from the Southeastern region, 20% (n ⫽ 23) from the Midwestern region, 26% (n ⫽ 31) from the Southwestern region, and 20% (n ⫽ 24) were from the Western region. Coverage Policies for Prophylactic Mastectomy and Oophorectomy in High-Risk Patients The health insurance coverage policies for prophylactic mastectomy and oophorectomy for all responding health carriers are presented in Table 2. Concerning bilateral prophylactic mastectomy, approximately 30% of the overall health insurance carriers responding had a policy to specifically cover this surgery if the patient had a strong family history of breast cancer or a BRCA mutation. Twenty-nine percent (n ⫽ 43) of the overall respondents had a formal policy of noncoverage for prophylactic mastectomy for a strong family history of

TABLE 2. Health insurance coverage policies for breast and ovarian cancer prophylactic surgery

Procedure and clinical circumstance Prophylactic mastectomy for a patient with a strong family history of breast cancer Total responding plans Governmental carriersa Nongovernmental plans Prophylactic mastectomy for a patient with a BRCA gene mutation Total responding plans Governmental carriersa Nongovernmental plans Prophylactic oophorectomy for a patient with a strong family history of ovarian carcinoma Total responding plans Governmental carriersa Nongovernmental plans Prophylactic oophorectomy for a patient with a BRCA gene mutation Total responding plans Governmental carriersa Nongovernmental plans

No. covered (%)

No. not covered (%)

No. with no coverage policy (%)

44 (29) 1 (2) 43 (44)

43 (29) 29 (56) 14 (14)

63 (42) 22 (42) 41 (42)

42 (28) 5 (10) 37 (38)

36 (24) 26 (50) 10 (10)

72 (48) 21 (40) 51 (52)

27 (18) 2 (4) 25 (26)

42 (28) 27 (52) 15 (15)

81 (54) 23 (44) 58 (59)

30 (20) 6 (12) 24 (24)

36 (24) 25 (48) 11 (11)

84 (56) 21 (40) 63 (64)

a Governmental carriers refers to Medicare and Medicaid respondents; all other responding plans are referred to as nongovernmental plans. The distribution of health insurance coverage policies between governmental and nongovernmental plans was significantly different for both prophylactic mastectomy and oophorectomy under all clinical circumstances noted (P ⬍ .001).

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breast cancer, and 24% (n ⫽ 36) had a formal policy of noncoverage for prophylactic mastectomy if the patient had a BRCA mutation. Approximately 45% of respondents had no coverage policy for bilateral prophylactic mastectomy for either a strong family history of breast cancer or a BRCA mutation. With regard to prophylactic oophorectomy, approximately 20% of the overall health insurance carriers responding had a policy to specifically cover this surgery if the patient had a strong family history of ovarian cancer or a BRCA mutation. The relative percentage of formal noncoverage policy for prophylactic oophorectomy was very similar to that of prophylactic mastectomy. Twentyeight percent (n ⫽ 42) of the overall respondents had a formal policy of noncoverage for prophylactic oophorectomy for a strong family history of ovarian cancer and 24% (n ⫽ 36) a formal policy of noncoverage for prophylactic oophorectomy if the patient had a BRCA mutation. Approximately 55% of the total respondents had no coverage policy for prophylactic oophorectomy for a strong family history of ovarian cancer or a BRCA mutation. When a respondent indicated that no specific coverage policy existed for prophylactic mastectomy or oophorectomy, the insurance provider was asked to identify how individual coverage or medical necessity decisions are made within their organization. For the entire group of respondents, there were a total of 108 insurance carriers that did not have a formal coverage policy for prophylactic mastectomy, oophorectomy, or both, for patients with either a genetic mutation or a strong family history of breast or ovarian cancer. When no coverage policy existed, the final decision concerning coverage for the surgical procedure was reported to be made by the medical director in 66% (n ⫽ 71), the chief executive officer or president in 1% (n ⫽ 1), a financial representative in 1% (n ⫽ 1), a committee in 11% (n ⫽ 12), or by some other mechanism in 21% (n ⫽ 23) of the respondents. A comparison between the reimbursement policies of responding governmental carriers (Medicare carriers and state Medicaid programs) with that of the nongovernmental health plan respondents identified some noteworthy differences (Table 2). The governmental carriers were approximately twice as likely to have formal noncoverage policies for prophylactic mastectomy and oophorectomy compared with nongovernmental plans (P ⬍ .001). In a similar manner, only a small percentage of governmental respondents (range, 2%–12%) had a policy of coverage for prophylactic mastectomy and oophorectomy compared with the nongovernmental health plan respondents (range, 24%– 44%). Ann Surg Oncol, Vol. 7, No. 5, 2000

Of the 98 nongovernmental responding health insurance carriers, approximately 40% cover prophylactic mastectomy for a patient with a strong family history of breast cancer or a BRCA mutation. Approximately onefourth of the nongovernmental health insurance carriers have a policy for coverage of prophylactic oophorectomy for a patient with a strong family history of ovarian cancer or a BRCA mutation. There were no statistical differences in coverage policy, based on the region of the United States in which a patient was an enrolled member, for prophylactic mastectomy for a strong family history of breast cancer (P ⫽ .59), for prophylactic mastectomy for a patient with a BRCA mutation (P ⫽ .31), for prophylactic oophorectomy for a strong family history of ovarian cancer (P ⫽ .58), and for prophylactic oophorectomy for a patient with a BRCA mutation (P ⫽ .99). Fifty-three percent of the nongovernmental health insurance carriers identified themselves as being “for-profit.” Therefore, it was of interest to analyze the coverage policies for prophylactic surgery based on the profit status of the responding nongovernmental health insurance carriers. In general, for-profit health insurance carriers were more likely to cover prophylactic surgeries than nonprofit carriers, although the differences did not reach statistical significance. Looking more closely, 48% percent of for-profit carriers compared with 39% of nonprofit carriers had a policy of coverage for prophylactic mastectomy for a strong family history of breast cancer (P ⫽ .67), 42% percent of for-profit carriers compared with 33% of non-profit carriers had a policy of coverage for prophylactic mastectomy for patients with a BRCA mutation (P ⫽ .61), 29% percent of for-profit carriers compared with 22% of nonprofit carriers had a policy of coverage for prophylactic oophorectomy for a strong family history of ovarian cancer (P ⫽ .28), and 29% percent of for-profit carriers compared with 20% of nonprofit carriers had a policy of coverage for prophylactic oophorectomy for patients with a BRCA mutation (P ⫽ .15). Coverage Policies for Synchronous Elective Contralateral Mastectomy Existing health insurance coverage policies were also explored for synchronous contralateral mastectomy if the patient had an ipsilateral diagnosis of breast cancer or atypical hyperplasia. As shown in Table 3, of the total responding health plans, 32% (n ⫽ 48) had a formal policy that allowed for coverage of synchronous elective contralateral mastectomy, 26% (n ⫽ 39) had a specific policy that did not allow for coverage of synchronous elective contralateral mastectomy, and 42% (n ⫽ 63) had no policy for coverage of synchronous elective contralat-

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TABLE 3. Health insurance coverage policies for synchronous elective contralateral mastectomy No. with no No. covered No. not covered coverage policy (%) (%) (%)

Procedure and clinical circumstance Contralateral mastectomy for a patient with an ipsilateral breast cancer or atypical hyperplasia Total responding plans Governmental carriersa Nongovernmental plans

48 (32) 2 (4) 46 (47)

39 (26) 27 (52) 12 (12)

63 (42) 23 (44) 40 (41)

a Governmental carriers refers to Medicare and Medicaid respondents; all other responding plans are referred to as nongovernmental plans. The distribution of health insurance coverage policies between governmental and nongovernmental plans was significantly different (P ⬍ .001).

eral mastectomy at all. The distribution of health insurance coverage policies for synchronous elective contralateral mastectomy was significantly different between governmental and nongovernmental plans (P ⬍ .001). Fifty-two percent of the governmental respondents had a formal noncoverage policy for this procedure compared with 12% on the nongovernmental respondents. Only 4% of governmental respondents had a policy of coverage for this procedure compared with 47% of the nongovernmental respondents. DISCUSSION At present, there are only two potentially effective methods to decrease risk of cancer development in women with a hereditary predisposition for breast and ovarian carcinoma. These methods include chemoprevention and prophylactic surgery. Although increased surveillance in the form of more extensive and frequent physical examinations, diagnostic mammography, vaginal probe ultrasonography, and serum CA-125 determination may detect breast and ovarian carcinoma at an earlier stage, this remains to be proven.11,12 However, early detection of cancer does not prevent the psychological ramifications associated with a new cancer diagnosis or the need for often potentially extensive treatments. Concerning chemoprevention, the National Surgical Adjuvant Breast and Bowel Project Breast Cancer Prevention Trial has recently demonstrated that tamoxifen can decrease the frequency of breast cancer in woman at increased risk with and without a family history of breast cancer by approximately 50%.13 In this study, peripheral blood was also obtained from participants to determine how many of them had BRCA1 or BRCA2 mutations and whether tamoxifen decreased their breast cancer risk. Information about the mutation status of the study participants in the breast cancer prevention trial is not yet available. However, looking at documented BRCA1 and BRCA2 carriers specifically in another study, the use of oral contraceptives for 6 or more years has been shown

to reduce the risk of developing ovarian carcinoma by 60%.14 In the coming years, better chemopreventive agents are expected to be developed and tested in women at increased risk. The concept of prophylactic surgery to reduce organspecific cancer risk has become a part of the standard management in two inherited cancer syndromes. At present, prophylactic thyroidectomy is generally recommended for patients with multiple endocrine neoplasia type 2a and the RET mutation, and prophylactic colectomy is generally recommended for patients with familial adenomatous polyposis who carry the APC (antigenpresenting cell) mutation.15 For many decades, women at a perceived increased risk for breast cancer have chosen to have prophylactic mastectomy to reduce their chances of developing disease. Up until the recent publication of Hartmann et al.,6 there was little published scientific evidence of the efficacy of this procedure in reducing breast cancer frequency in high-risk women. In this landmark single-institution study, 639 women with a family history of breast cancer who underwent bilateral prophylactic mastectomy (90% subcutaneous and 10% total) were analyzed. Compared with the sisters of these women who did not receive prophylactic mastectomy and who served as controls, this surgery was associated with a reduction of at least 90% in both the frequency of breast cancer and the risk of death from disease. In counseling women with regard to breast cancer risk reduction, it is noteworthy that prophylactic mastectomy may not be entirely effective in preventing breast carcinoma in high-risk patients. The efficacy of this procedure is dependent on the ability to remove nearly all breast tissue and on the supposition that the risk of breast cancer occurrence is proportional to the amount of residual breast tissue after mastectomy.16 Thus, subcutaneous mastectomy in which the surgery is performed from an inframammary incision and the nipple areola complex is preserved is likely to be less effective in reducing risk than a meticulously performed total mastectomy with removal of the pectoralis fascia. In this regard, several series and case reports have documented the occurrence Ann Surg Oncol, Vol. 7, No. 5, 2000

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of breast cancer after prophylactic mastectomy.6,16 –19 The true frequency of this phenomenon is unknown because most reports lack an accurate denominator for comparison with an appropriate control group of women not undergoing prophylactic mastectomy, limited patient follow-up, and no randomized trials of this procedure has or will likely ever be performed in high-risk women. Nevertheless, from the available scientific literature, healthcare providers generally now agree that, although this procedure may not entirely reduce risk, it can markedly reduce risk. Furthermore, advances in autogenous tissue reconstruction and the increasing use of techniques such as skin-sparing mastectomy, have made total mastectomy with immediate breast reconstruction a more appealing option than either chemoprevention or increased surveillance for some women.20 –23 Prophylactic oophorectomy after child-bearing is generally strongly considered in women who are known carriers of BRCA mutations and in women from highprevalence ovarian cancer families.24,25 Oophorectomy has been shown to substantially reduce the risk of ovarian cancer development in women at high risk for this disease.7 Although intraperitoneal carcinomatosis indistinguishable from ovarian carcinoma has been reported in women who have had oophorectomy, the chance of this occurring after oophorectomy has been reported to occur in only 2% to 11% of high-risk women undergoing this procedure.26,27 Prophylactic oophorectomy may not only reduce ovarian cancer risk but also the chances of developing breast cancer in high-risk women. In a recent cohort analysis of women with the BRCA1 mutation, the risk of breast cancer development was reduced by approximately 50% in patients who had undergone bilateral prophylactic oophorectomy.8 With regard to prophylactic surgery in BRCA 1 and 2 mutation carriers, two independent groups have developed decision analysis models that suggest that prophylactic mastectomy and oophorectomy will substantially improve survival among young women with these mutations.28,29 Furthermore, both of these studies indicate that prophylactic surgery is cost effective for years of life saved compared to other interventions that our society deems to be cost effective. Synchronous elective contralateral prophylactic mastectomy with or without bilateral breast reconstruction is also a controversial procedure that is sometimes considered by patients with a current ipsilateral diagnosis of breast cancer or atypia.23 Histories of breast cancer or atypical hyperplasia are important risk factors for the development of contralateral invasive breast cancer.30 –32 The risk of contralateral breast cancer in women with a previous history of atypical hyperplasia or breast cancer Ann Surg Oncol, Vol. 7, No. 5, 2000

is estimated to be 0.7% to 1% per year.23,30 –32 For women with known mutations in BRCA1 or BRCA2, the rate of contralateral breast cancer development has been reported to be as high as 5.6% per year.33 Approximately half of the nongovernmental health insurance respondents indicated a policy of coverage for contralateral prophylactic mastectomy in a patient with ipsilateral breast cancer or a diagnosis of atypical hyperplasia in our present study. Although this procedure is not widely advocated by physicians for most women with an ipsilateral breast cancer diagnosis, it remains a reasonable option in reducing contralateral breast cancer occurrence in selected high-risk patients with difficult clinical or mammographic contralateral examinations who do not wish to take chemopreventive medications such as tamoxifen and who have had appropriate counseling regarding actual breast cancer risk assessment.34 In summary, the results of this current study indicate that most private and governmental health carriers either have no coverage policies for prophylactic mastectomy and oophorectomy or do not cover these procedures. About 40% of private health insurance plans have specific policies for coverage of prophylactic mastectomy in those women with either a strong family history of breast cancer or who carry a deleterious BRCA mutation. In a similar manner, only about a quarter of responding nongovernmental health plans have specific policies for coverage of prophylactic oophorectomy. Even a smaller percentage of governmental plan respondents (range, 2%–12%) indicated that these procedures might be covered. Furthermore, coverage policies for these prophylactic surgeries appeared to be independent of the patients’ enrollment region within the United States. When no specific coverage policy exists, the decision of whether to cover these surgeries in a specific case is made by an individual plan medical director the majority of times. When no global health insurance coverage policy exists, it is feared that critical healthcare decisions may be subject to arbitrary criteria and likely that there will be substantial variation in coverage decisions that are reached. There were some limitations of this study. The overall response rate was only 31% and, although low, it was comparable to other similar health coverage policy surveys.10 This overall response rate might imply that actual coverage rates for these procedures are even lower than found in the present study. In addition, the responses indicated on our survey may not represent actual practice by plan medical directors. Nevertheless, the results of this survey represent current information on health insurance coverage policy for prophylactic surgery for several million American women from all regions within

U.S. HEALTH INSURANCE COVERAGE FOR CANCER PROPHYLACTIC SURGERY the United States, and from the private as well as public sector. A more accurate method to determine current health insurance coverage practices regarding prophylactic surgery would be to prospectively identify women undergoing these procedures from around the country and document actual insurance payments received or denied. Despite the limitations of the present study, we believe that the data are likely to be an accurate reflection of actual current insurance coverage practice, because proprietary concerns should have been minimized by the confidential design of the survey. We do not believe that prophylactic mastectomy or oophorectomy should be categorically recommended to any particular group of women at increased risk for breast or ovarian carcinoma. However, in the context of counseling regarding risk assessment and reduction, the available literature supports the efficacy of both prophylactic mastectomy and oophorectomy as valid potentially risk-reducing medical interventions for women at increased risk. Because prophylactic mastectomy and oophorectomy remain options among the risk-reducing techniques for women, our healthcare system should provide all appropriate candidates with equal access and coverage for these procedures.

11.

12.

13.

14.

15. 16.

17. 18. 19.

20.

21.

Acknowledgments: The authors thank Ms. Diane Wong for her efforts in data retrieval and preparation of this manuscript. 22.

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