Clinical Policy Title: Prophylactic salpingo-oopherectomy
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1 Clinical Policy Title: Prophylactic salpingo-oopherectomy Clinical Policy Number: Effective Date: January 1, 2017 Initial Review Date: October 19, 2016 Most Recent Review Date: November 16, 2017 Next Review Date: November 2018 Related policies: Policy contains: Breast cancer susceptibility gene (BRCA 1-2) gene mutation. Lynch syndrome. Mastectomy. Oophorectomy. Salpingectomy. CP# CP# Prophylactic mastectomy COLARIS testing for Lynch syndrome ABOUT THIS POLICY: Select Health of South Carolina has developed clinical policies to assist with making coverage determinations. Select Health of South Carolina s clinical policies are based on guidelines from established industry sources, such as the Centers for Medicare & Medicaid Services (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peerreviewed professional literature. These clinical policies along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including any state- or plan-specific definition of medically necessary, and the specific facts of the particular situation are considered by Select Health of South Carolina when making coverage determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws and/or regulatory requirements shall control. Select Health of South Carolina s clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment decisions for their patients. Select Health of South Carolina s clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, Select Health of South Carolina will update its clinical policies as necessary. Select Health of South Carolina s clinical policies are not guarantees of payment. Coverage policy Select Health of South Carolina considers prophylactic salpingo-oophorectomy to be clinically proven, and, therefore, medically necessary for a woman when any of the following criteria is met: A positive test result for the breast cancer susceptibility gene (BRCA 1 or 2) mutations exist. A personal history of breast cancer with at least one first-degree relative (mother, sister, or daughter) with a documented history of ovarian cancer. One or more first- or second-degree relatives (maternal or paternal aunt, grandmother, or niece) have a history of ovarian cancer. Two or more first-degree relatives (mother, sister, or daughter) have a history of ovarian and/or breast cancer. One first-degree relative (mother, sister, or daughter) and one or more second-degree relatives (maternal or paternal aunt, grandmother, or niece) have a history of ovarian cancer. The woman is beyond childbearing age and has been diagnosed with a known familial cancer, such as Lynch syndrome (hereditary non-polyposis colorectal cancer, or HNPCC), a hereditary 1
2 ovarian cancer syndrome (ACOG, 2009; AHRQ, 2012; Berek, 2010; NCCN, 2016; SGO, 2013; USPTF, 2005). In addition, Select Health of South Carolina considers prophylactic hysterectomy medically necessary when performed in conjunction with prophylactic salpingo-oophorectomy when any of the following criteria are met: A Lynch syndrome II mutation is documented. The woman meets the criteria for prophylactic salpingo-oophorectomy and, after a risk and benefit discussion with her physician, chooses to have prophylactic hysterectomy in conjunction with oophorectomy. Limitations: Before prophylactic salpingo-oophorectomy is performed for a woman in her reproductive years, a sterilization consent form may be required. Select Health of South Carolina considers prophylactic salpingo-oophorectomy to be investigational, and therefore, not medically necessary, for all other conditions. Alternative covered services: Prophylactic mastectomy. Background Hereditary susceptibility to cancer is now expanding with the growing knowledge of genetic mutation patterns. The National Cancer Institute (NCI) defines criteria for hereditary susceptibility in both the individual patient, and in the patient s family (NCI, 2013a). The list of criteria in the patient is extensive, and includes existence of multiple tumors, age, histology types, and other genetic traits. NCI defines hereditary susceptibility in the patient s family to include any of: One first-degree relative with the same or a related tumor and one of the individual features listed. Two or more first-degree relatives with tumors at the same site. Two or more first-degree relatives with tumor types belonging to a known familial cancer syndrome. Two or more first-degree relatives with rare tumors. Three or more relatives in two generations with tumors at the same site or etiologically related sites. 2
3 As of 2015, there are 21 genes associated with increased risk of breast and ovarian cancer. These can be subdivided into three groups (i.e., high-, moderate-, and newer risk). The high- and moderate-risk genes have been well studied, and can increase risk for other cancers; they differ in that breast or ovarian cancer risk is typically elevated at least four-fold for high-risk genes and two to three fold for moderaterisk genes. Precise risks for the newer genes are still being calculated (GeneDx, 2015). The BRCA 1 and 2 genetic mutations, first identified in 1994, are most common and best understood. They can be inherited from a woman s father or mother. These mutations account for 5 percent to 10 percent of all breast cancers and 10 percent of ovarian cancers. BRCA mutations mean an increased risk of breast cancer for women by age 70. This elevated risk is 55 to 65 percent for BRCA1-positive women and 45 percent for BRCA2-positive women (Antoniou, 2003). The normal lifetime risk of the disease is 12 percent (NCI, 2015). There is considerable variation in BRCA prevalence by racial and ethnic groups of the estimated 300,000 U.S. women with the mutation. A survey of 1,727 women with breast cancer under age 65 provided the basis for prevalence estimates of the BRCA1 mutation in Northern California. Jewish women of Ashkenazi descent were highest at 8.3 percent, followed by Hispanics (3.5 percent), non-hispanic whites (2.2 percent), African Americans (1.5 percent), and Asian Americans (0.5 percent). The authors speculate that the Hispanic rate may be somewhat inflated by the presence of unrecognized Jewish ancestry (John, 2007). The total prevalence of women with hereditary susceptibility to breast and ovarian cancer is higher than the cited figures, as they only include BRCA1-positive women and not BRCA2-positive or other known and unknown mutations. In addition, hereditary mutations are not always detected in high-risk women. For example, in a sample of 236 Ashkenazi Jewish women with breast cancer and a family history of breast or ovarian cancer, the likelihood of detecting a mutation was 32.1 percent (Robson, 1997). The probability of a young woman diagnosed with a BRCA mutation surviving to age 70 without treatment is just 53 percent and 71 percent for BRCA 1 and 2 carriers, respectively, compared to a probability of 84 percent for the general population (Kurian, 2010). Dramatic declines in incidence of breast cancer have been observed in BRCA-positive women after prophylactic salpingo-oophorectomy, which has reduced lifetime breast cancer risk by more than 95 percent. In addition, breast cancer risk declined 90 percent among those women who have a strong family history of the disease (Domchek, 2010). BRCA is also an indicator for greater risk of ovarian cancer by age 70. This risk is 39 percent for BRCA1- positive women and 11 to 17 percent for BRCA2-positive women (Antoniou, 2003). The lifetime risk of ovarian cancer in the general female population is just 1.3 percent (NCI 2015). Prophylactic salpingooophorectomy has reduced the risk of ovarian and breast cancer by 90 percent and 50 percent, respectively (Guillem, 2006). 3
4 Needed services among women likely to have a genetic mutation for elevated breast and ovarian cancer risk are underutilized. An estimated 10 to 15 percent of at-risk and asymptomatic women have discussed genetic testing with a health professional, four to eight percent received advice from a professional to undergo a genetic test, and fewer than three percent have had such a test (Levy, 2009). Despite large demonstrated reductions in breast cancer risks to high-risk women, only a minority of women with BRCA mutations elect to undergo prophylactic procedures. A study of 2,677 BRCA-positive and asymptomatic women ages 25 to 79, tracked for an average of 3.9 years, documented the U.S. as the nation with the highest proportion of these women who elect to undergo prophylactic mastectomy and salpingo-oophorectomy (36.3 percent and 71.1 percent, respectively). Poland, whose corresponding numbers are 2.7 percent and 34.9 percent, has the lowest such proportion (Metcalfe, 2008). Social beliefs and practices, along with effectiveness of provider counseling, may account for much of this variation. Prophylactic mastectomy and prophylactic salpingo-oophorectomy were first performed soon after the discovery of BRCA gene mutations and the accompanying genetic tests. Originally, the procedures were performed separately, but now are typically concurrent if the woman elects to undergo prophylactic surgery. A salpingo-oopherectomy involves removal of the fallopian tubes (salpingectomy) and ovaries (oophorectomy). Removal of both ovaries and fallopian tubes is the standard of care (ACOG, 2009), although some women elect to undergo just one of the procedures. An alternative to prophylactic salpingo-oophorectomy to reduce ovarian cancer risk is increased surveillance or more frequent screening exams. Another option is use of oral contraceptives, which reduced ovarian cancer risk by 50 percent over five years, a benefit that lasted for at least 10 years after cessation (Hankinson, 1992). Questions remain about how effective these alternatives are at reducing risk, especially for early-stage ovarian cancer. Women diagnosed with Lynch syndrome, also known as HNPCC, have a 40 to 60 percent lifetime risk of endometrial cancer, and a 10 to 12 percent chance of ovarian cancer, along with elevated risks of uterine, stomach, and colorectal cancers. Mutations associated with this syndrome include MLH1, MSH2, and MSH6. Prophylactic salpingo-oophorectomy and hysterectomy, for these women, have been considered as a means of reducing risk of these cancers (Burke, 1997). Searches Select Health of South Carolina searched PubMed and the databases of: UK National Health Services Centre for Reviews and Dissemination. Agency for Healthcare Research and Quality s National Guideline Clearinghouse and other evidence-based practice centers. 4
5 The Centers for Medicare & Medicaid Services (CMS). We conducted searches on October 13, Search terms were: prophylactic salpingooophorectomy and prophylactic salpingo-oophorectomy. We included: Systematic reviews, which pool results from multiple studies to achieve larger sample sizes and greater precision of effect estimation than in smaller primary studies. Systematic reviews use predetermined transparent methods to minimize bias, effectively treating the review as a scientific endeavor, and are thus rated highest in evidence-grading hierarchies. Guidelines based on systematic reviews. Economic analyses, such as cost-effectiveness, and benefit or utility studies (but not simple cost studies), reporting both costs and outcomes sometimes referred to as efficiency studies which also rank near the top of evidence hierarchies. Findings The most recent version of several guidelines by the National Comprehensive Cancer Network (NCCN) on BRCA-positive women recommends prophylactic salpingo-oophorectomy, typically at ages 35 to 40 and on completion of childbearing (NCCN, 2016). The American College of Obstetrics and Gynecology (ACOG) also endorses prophylactic salpingo-oophorectomy for high-risk women, based on difficulties in detecting ovarian cancer and poor prognosis for treating advanced cases (ACOG, 2009). ACOG also recommends prophylactic salpingo-oophorectomy include inspection of the peritoneal cavity, pelvic washings, removal of fallopian tubes, and ligation of ovarian vessels at the pelvic brim (AHRQ, 2012). The U.S. Preventive Services Task Force concludes that fair evidence exists that prophylactic salpingooophorectomy effectively prevents breast and ovarian cancer (USPSTF, 2005). The Society of Gynecologic Oncology (SGO) recommends that physicians counsel high-risk women to have fallopian tubes removed, followed by ovary removal (SGO, 2013). SGO also classifies women with family history of breast and/or ovarian cancer, but with no confirmation of BRCA mutations as higher-than-average risk for both diseases (Berek, 2010). The National Cancer Institute recommends that risk-reducing hysterectomy, along with prophylactic salpingo-oophorectomy, be considered as an option for women with Lynch syndrome (NCI, 2013b). All guidelines emphasize the importance of the provider and patient discussing risks and benefits of prophylactic salpingo-oophorectomy before any procedure is performed. Women undergoing prophylactic salpingo-oophorectomy frequently experience menopausal symptoms, including osteoporosis, increased heart disease risk, hot flashes, sleep disturbance, and cognitive changes (Domchek, 2007). 5
6 Prophylactic salpingo-oophorectomy has been shown to reduce breast cancer risk by 47 to 68 percent, and reduce risk of cancers of the ovary, fallopian tube, and peritoneum by 71 to 96 percent if completed before menopause, based on six trials (Rebbeck, 2009). Several meta-analyses and systematic reviews found that prophylactic salpingo-oophorectomy: Reduced breast cancer risk in BRCA-positive women. The procedure also significantly reduced all-cause mortality in these women, while PPM did not (Li, 2016). Was associated with large decreases in breast and ovarian cancer incidence, plus mortality from all causes (Nelson, 2014). Was associated with a reduction (versus non-surgical BRCA cases) of 68 percent, and a reduction of ovarian cancer risk of 80 percent in studies followed 3.4, 5.6, and 6.2 years (Marchetti, 2014). Kurian (2010) estimated survival gain for BRCA-positive women by age. Table 1 shows the percentage survival of these women at age 70, according to age at each type of intervention: Table 1 Overall survival probability to age 70, in percentage of 25-year-old women with BRCA 1 or 2 mutation Age at Prophylactic Salpingo-Oophorectomy None Age 40 Age 50 BRCA1 carriers No screening, no prophylactic mastectomy Screening, no prophylactic mastectomy Screening, prophylactic mastectomy age Screening, prophylactic mastectomy age Screening, prophylactic mastectomy age No screening, prophylactic mastectomy age BRCA2 carriers No screening, no prophylactic mastectomy Screening, no prophylactic mastectomy Screening, prophylactic mastectomy age Screening, prophylactic mastectomy age Screening, prophylactic mastectomy age No screening, prophylactic mastectomy age General U.S. female population The most efficacious single intervention is prophylactic salpingo-oophorectomy at age 40 for BRCA1 carriers (survival increase from 53 to 68 percent), versus BRCA2 carriers (survival increase from 71 to 77 percent). Prophylactic mastectomy at age 25 or 30 plus prophylactic salpingo-oophorectomy at age 40 yields the greatest survival for BRCA 1 and 2 carriers (79 percent and 83 percent, versus 84 percent for all U.S. females). Patterns are similar to age 80. 6
7 A cost-effectiveness study of BRCA-positive Norwegian women who underwent prophylactic salpingooophorectomy found an additional 6.4 discounted life years gained in women also undergoing prophylactic mastectomy (3.1 for those with just prophylactic salpingo-oophorectomy), versus BRCApositive women with no intervention (Norum, 2008). The cost per life year gained was euro 1973 (prophylactic salpingo-oophorectomy alone) and euro 1749 (both procedures); researchers concluded these interventions were cost-effective. In a comparison of prophylactic salpingo-oophorectomy with prophylactic salpingectomy, with and without delayed oophorectomy, prophylactic salpingo-oophorectomy was associated with the lowest cost, greatest life expectancy, and greatest declines in breast and ovarian cancer risk (Kwon, 2013). However, after adjusting for quality-of-life measures, prophylactic salpingectomy with delayed oophorectomy had the highest life expectancy. Younger age at prophylactic salpingo-oophorectomy was associated with lower social functioning and greater anxiety, while playing a sport and avoiding weight gain were highly related to better quality of life after surgery (Touboul, 2011). Research has addressed whether salpingectomy alone reduces ovarian cancer risk. One large population-based study showed that women with prior salpingectomy had a 35 percent lower risk of ovarian cancer, and a 50 percent reduction with salpingectomy. This finding supports the belief that most ovarian cancers originate in the fallopian tubes (Falconer, 2015). Likewise, studies of oophorectomy alone have demonstrated shown a reduction in ovarian cancer. An analysis of nine studies documented oophorectomy versus ovarian conservation lowered future ovarian cancer rates for women with a family history of breast or ovarian cancer and BRCA1 carriers; evidence for BRCA2 carriers was low quality (Hayes, 2013). In 1997, the Cancer Genetics Studies Consortium found insufficient evidence to recommend if prophylactic hysterectomy and salpingo-oophorectomy would reduce cancer risk in women with Lynch syndrome (Burke, 1997). Subsequently, a study of Lynch syndrome compared those 61 who underwent hysterectomy (47 also with prophylactic bilateral salpingo-oophorectomy) to 210 with no surgery. Cases and controls were followed for an average of 13 and seven years, respectively. Cases had no subsequent endometrial or ovarian cancer, while controls had 12 cases of ovarian cancer and 69 cases of endometrial cancer (Schmeler, 2006). A review of 21,067 Australian women diagnosed with primary breast cancer from 1997 to 2008 also compared those undergoing hysterectomy, prophylactic bilateral salpingo-oophorectomy, both procedures, and no surgery. After tracking women for five to seven years, those with both procedures had an improvement in 10-year survival from 78.5 to 85.0 percent), while those with only one of these procedures showed no change (Obermair, 2014). Policy updates: 7
8 In 2017, three guidelines were added to the reference list. Summary of clinical evidence: Citation Li (2016) Effectiveness of prophylactic surgeries in BRCA1 or BRCA2 mutation carriers Nelson (2014) Reductions in cancer risk in BRCA-positive women Kurian (2010) Improvements in survival to BRCA-positive women by type of treatment Metcalfe (2008) Proportions of BRCApositive women who elect to undergo prophylactic procedures, by nation Schmeler (2006) Content, Methods, Recommendations Key points: Meta-analysis of 15 studies of women undergoing prophylactic salpingo-oophorectomy or prophylactic mastectomy. Prophylactic salpingo-oophorectomy and prophylactic mastectomy were associated with decreased breast cancer risk. Prophylactic salpingo-oophorectomy was associated with significantly decreased all-cause mortality. BPM was not associated with significantly decreased all-cause mortality. Key points: Systematic review of five studies, BRCA-positive women who did or did not have risk-reducing surgery. PPM reduced incidence of breast cancer by 85 percent 100 percent. Prophylactic salpingo-oophorectomy (versus no surgery) reduced incidence of breast cancer by 37 percent -100 percent, incidence of ovarian cancer by 69 percent -100 percent, mortality from all causes by 55 percent -100 percent. Key points: Young women diagnosed with the BRCA 1-2 mutations have a 53 percent and 71 percent chance of surviving to age 70 without treatment. Survival gain to age 70 for BRCA 1-2 carriers is 15 percent and 7 percent after PSO at age 40. Survival gain to age 70 for BRCA 1-2 carriers is 24 percent and 11 percent after prophylactic salpingo-oophorectomy at 40 plus BPM. PBM at age 25 offers minimal benefit compared to age 40. Key points: 2,677 BRCA-positive and asymptomatic women, ages 25 79, tracked an average of 3.9 years. U.S. has highest percentage undergoing PBM and prophylactic salpingo-oophorectomy (36.3 percent and 71.1 percent). Poland has the lowest proportions (2.7 percent and 34.9 percent). Social beliefs and practices, and effectiveness of counseling, account for differences. Key points: Preventing cancer in women with Lynch syndrome Australian women (n=270) with Lynch syndrome. 61 had hysterectomy (47 of whom also had prophylactic salpingo-oophorectomy), others had no surgery. Surgical and non-surgical groups tracked an average of 13 and 7 years. Surgical group had zero endometrial, ovarian, or primary peritoneal cancers. Non-surgical group had 12 ovarian and 69 endometrial cancers. 8
9 References Professional society guidelines/other: Agency for Healthcare Research and Quality (AHRQ). Elective and risk-reducing salpingo-oophorectomy. First presented September 1999, reaffirmed Accessed October 12, American College of Obstetricians and Gynecologists (ACOG). Elective and risk-reducing salpingooophorectomy. NGC: September 1999; Revised January 2008; Reaffirmed Accessed October 19, American College of Obstetricians and Gynecologists (ACOG). ACOG Practice Bulletin No. 103: Hereditary breast and ovarian cancer syndrome. Obstet Gynecol. 2009; 113(4): doi: /AOG.0b013e3181a106d4. Berek JS, Chalas E, Edelson M, et al (Society of Gynecologic Oncologists Clinical Practice Committee). Prophylactic and risk-reducing bilaterial salpingo-ooporectomy: Recommendations based on risk of ovarian cancer. Obstet Gynecol. 2010; 116(3): doi: /AOG.0b013e3181ec5fc1. Hayes Inc., Hayes Medical Technology Directory. Prophylactic oophorectomy for the prevention of ovarian cancer. Lansdale, Pa. Hayes Inc.; December 12, Levy DE, Garber JE, Shields AE. Guidelines for genetic risk assessment of hereditary breast and ovarian cancer: early disagreements and low utilization. J Gen Intern Med. 2009; 24(7): doi: /s Moyer VA, on behalf of the U.S. Preventive Services Task Force. Risk Assessment, Genetic Counseling, and Genetic Testing for BRCA-Related Cancer in Women: U.S. Preventive Services Task Force Recommendation Statement. Ann Intern Med. 2014;160: doi: /M National Cancer Institute (NCI). Cancer Genetics Overview (PDQ ) Updated August 17, (a) Accessed October 19, National Cancer Institute (NCI). Genetics of colorectal cancer (PDQ ) Updated October 5, (b) Accessed October 19, National Cancer Institute (NCI), Surveillance, Epidemiology, and End Results Program. SEER Cancer 9
10 Statistics Review, National Cancer Institute. Bethesda MD, Posted April National Comprehensive Cancer Network (NCCN). Ovarian cancer including fallopian tube cancer and primary peritoneal cancer. Version 3;2017. NCCN Clinical Practice Guidelines in Oncology. National Comprehensive Cancer Network; Fort Washington, Pennsylvania. August 30, Accessed October 19, Society of Gynecologic Oncology (SGO). SGO clinical practice statement: Salpingectomy for ovarian cancer prevention. November Accessed October 19, Peer-reviewed references: Antoniou A, Pharoah PD, Narod S, et al. Average risks of breast and ovarian cancer associated with BRCA1 or BCA2 mutations detected in case series unselected for family history: A combined analysis of 22 studies. Am J Human Gen. 2003; 72(5): Burke W, Petersen G, Lynch P, et al. Recommendations for follow-up care of individuals with an inherited predisposition to cancer. I. Hereditary nonpolyposis colon cancer. Cancer Genetics Studies Consortium. JAMA. Mar ; 277(11): Domchek S, Friebel T, Singer C, et al. Association of risk reducing surgery in BRCA1 or BRCA2 mutation carriers with cancer risk and mortality. JAMA. 2010; 302: doi: /jama Domchek SM, Rebbeck TR. Prophylactic oophorectomy in women at increased risk. Curr Opin Obstet Gynecol. 2007; 19(1): doi: /GCO.0b013e da. Falconer H, Yin L, Gronberg H Altman D. Ovarian cancer risk after salpingectomy: a nationwide population-based study. J Natl Cancer Inst. 2015; 107(2): doi: /jncl/dju410. Hankinson SE, Colditz GA, Hunter DJ, Spencer TL, Rosner B, Stampfer MJ. A quantitative assessment of oral contraceptive use and risk of ovarian cancer. Obstet Gynecol. 1992; 80(4): Guillem JG, Wood WC, Moley JF, et al. ASCO/SSO review of current role of risk-reducing surgery in common hereditary cancer syndromes. J Clin Oncol. 2006; 24(28): John EM, Miron A, Gong G, et al. Prevalence of pathogenic BRCA1 mutation carriers in 5 US racial/ethnic groups. JAMA. 2007; 298(24): Kauff N, Domchek S, Frubel T, et al. Risk-reducing salpingo-oopherectomy for the prevention of BRCA1- and BRCA2-associated breast and gynecologic cancer: a multicenter, prospective study. J Clin Oncol. 10
11 2008; 26: doi: /JCO Kurian AW, Sigal BM, Plevritis SK. Survival analysis of cancer risk reduction strategies for BRCA 1-2 mutation carriers. J Clin Oncol. 2010; 2: doi: /JCO Kwon JS, Tinker A, Pansegrau G, et al. Prophylactic salpingectomy and delayed oophorectomy as an alternative for BRCA mutation carriers. Obstet Gynecol. 2013; 121(1): doi: Li X, You R, Wang X, et al. Effectiveness of prophylactic surgeries in BRCA1 or BRCA2 mutation carriers: A meta-analysis and systematic review. Clin Cancer Res. 2016; 22(15): doi: / CCR Madalinska JB, Hollenstein J, Bleiker E, et al. Quality-of-life effects of prophylactic salpingooophorectomy versus gynecologic screening among women at increased risk of hereditary ovarian cancer. J Clin Oncol. 2005; 23(28): Marchetti C, De Felice F, Palaia I, et al. Risk-reducing salpingo-oophorectomy: a meta-analysis on impact on ovarian cancer risk and all cause mortality in BRCA1 and BRCA2 mutation carriers. BMC Womens Health. 2014; 14: 150. doi: /s Metcalfe K, Birenbaum-Carmeli D, Lubinski J, et al. International variation in rates of uptake of preventive options in BRCA1 and BRCA2 mutation carriers. Int J Cancer. 2008; 122: doi: /ijc Nelson HD, Pappas M, Zakher B, Mitchell JP, Okinaka-Hu L, Fu R. Risk assessment, genetic counseling, and genetic testing for BRCA-related cancer in women: a systematic review to update the U.S. Preventive Services Task Force recommendation. Ann Intern Med. 2014; 160(4): doi: /M Norum J, Hagen AI, Maehle L, Apold J, Burn J, Moller P. Prophylactic bilateral salpingo-oophorectomy (PBSO) with or without prophylactic mastectomy (PBM) or no intervention in BRCA1 mutation carriers: a cost-effectiveness analysis. Eur J Cancer. 2008; 44(7): doi: /j.ejca Obermair A, Younden DR, Baade PD, Janda M. The impact of risk-reducing hysterectomy and salpingooophorectomy on survival in patients with a history of breast cancer a population-based data linkage study. Int J Cancer. 2014; 134(9): doi: /ijc Rebbeck T, Kauff N, Domchek S. Meta-analysis of risk reduction estimates association with risk-reducing salpingo oophorectomy in BRCA1 or BRCA2 mutation carriers. J Natl Cancer Inst. 2009; 101: Robson M, Dabney MK, Rosenthal G, et al. Prevalence of recurring BRCA mutations among Ashkenazi 11
12 Jewish women with breast cancer. Genet Test. 1997; 1(1): Schmeler KM, Lynch HT, Cen LM, et al. Prophylactic surgery to reduce the risk of gynecologic cancers in the Lynch syndrome. N Engl J Med. 2006; 19(354): Singh K, Lester J, Karlan B, Bresee C, Geva T, Gordon O. Impact of family history on choosing riskreducing surgery among BRCA mutation carriers. Am J Obstet Gynecol. 2013; 208(4): 329.e1 6. Touboul C, Uzan C, Ichante JL, et al. Factors associated with altered long-term well-being after prophylactic salpingo ophorectomy among women at increased hereditary risk for breast and ovarian cancer. Oncologist. 2011; 16(9): CMS National Coverage Determinations (NCDs): No NCDs identified as of the writing of this policy. Local Coverage Determinations (LCDs): No LCDs identified as of the writing of this policy. Commonly submitted codes Below are the most commonly submitted codes for the service(s)/item(s) subject to this policy. This is not an exhaustive list of codes. Providers are expected to consult the appropriate coding manuals and bill accordingly. CPT Code Description Comments Salpingo-oophorectomy, complete or partial, unilateral or (separate procedure) ICD-10 Code Description Comments Z15.01 Genetic susceptibility to malignant neoplasm of breast Z80.3 Family history of malignant neoplasm of breast Z80.41 Family history of malignant neoplasm of ovary Z85.3 Personal history of malignant neoplasm of breast HCPCS Level II Code N/A Description Comments 12
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