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Prophylactic Oophorectomy Name of Blue Advantage Policy: Prophylactic Oophorectomy Policy #: 259 Latest Review Date: August 2019 Category: Surgery Policy Grade: Active Policy but no longer scheduled for regular literature reviews and updates. Background: Blue Advantage medical policy does not conflict with Local Coverage Determinations (LCDs), Local Medical Review Policies (LMRPs) or National Coverage Determinations (NCDs) or with coverage provisions in Medicare manuals, instructions or operational policy letters. In order to be covered by Blue Advantage the service shall be reasonable and necessary under Title XVIII of the Social Security Act, Section 1862(a)(1)(A). The service is considered reasonable and necessary if it is determined that the service is: 1. Safe and effective; 2. Not experimental or investigational*; 3. Appropriate, including duration and frequency that is considered appropriate for the service, in terms of whether it is: • Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient’s condition or to improve the function of a malformed body member; • Furnished in a setting appropriate to the patient’s medical needs and condition; • Ordered and furnished by qualified personnel; • One that meets, but does not exceed, the patient’s medical need; and • At least as beneficial as an existing and available medically appropriate alternative. *Routine costs of qualifying clinical trial services with dates of service on or after September 19, 2000 which meet the requirements of the Clinical Trials NCD are considered reasonable and necessary by Medicare. Providers should bill Original Medicare for covered services that are related to clinical trials that meet Medicare requirements (Refer to Medicare National Coverage Determinations Manual, Chapter 1, Section 310 and Medicare Claims Processing Manual Chapter 32, Sections 69.0-69.11). Page 1 of 7 Proprietary Information of Blue Cross and Blue Shield of Alabama An Independent Licensee of the Blue Cross and Blue Shield Association Blue Advantage Medical Policy #259 Description of Procedure or Service: Prophylactic oophorectomy is the surgical removal of both ovaries to prevent the development of ovarian cancer in women who are at high risk for the disease. For those women at increased risk, prophylactic oophorectomy maybe considered after the age of 35 if childbearing is complete. The highest risk appears in women with 2 or more first-degree relatives with ovarian cancer. The most important risk factor for ovarian cancer is a family history of a first degree relative (e.g., mother daughter or sister) with the disease or presence of a BRCA1 or BRCA2 mutation. Increased screening and surveillance of patients at high risk of ovarian cancer have been unsuccessful in identifying patients early in the course of disease such that treatment results in a higher incidence of cure. Policy: Effective for dates of service on or after March 12, 2006: Blue Advantage will treat prophylactic oophorectomy or salpingo-oophorectomy as a covered benefit when the following guidelines are met: • Personal history of breast cancer, which is estrogen receptor positive and/or progesterone receptor positive, and who are premenopausal; OR • BRCA1 or BRCA2 mutation; OR • Two or more first-degree relatives (mother, sister, daughter) or one first-degree relative and one or more second-degree relatives (maternal or paternal grandmother, aunt or niece) with a history of ovarian cancer; OR • Strong family history of colon cancer in first-and/or second degree relatives; OR • Known familial cancer syndrome associated with increased risk of ovarian cancer (e.g., Lynch syndrome) For Multi-marker Serum Testing Related to Ovarian Cancer, please refer to MolDX. Blue Advantage does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. Blue Advantage administers benefits based on the members' contract and medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination. Key Points: According to the American Cancer Society, the estimated number of new cases of ovarian cancer for 2018 is over 22,000 and deaths from ovarian cancer exceed 14,000. Several cancers arise from the ovary. Epithelial carcinoma of the ovary is the most common ovarian malignancy. Gynecologic cancers, such as ovarian, fallopian tube, and primary peritoneum, account for the fifth most frequent cause of cancer death in women. Approximately 5% to 10% of ovarian Page 2 of 7 Proprietary Information of Blue Cross and Blue Shield of Alabama An Independent Licensee of the Blue Cross and Blue Shield Association Blue Advantage Medical Policy #259 cancers are familial and 3 distinct patterns have been identified: ovarian cancer alone, ovarian and breast cancers, or ovarian and colon cancers. BRCA In most families affected with breast and ovarian cancer syndrome or site-specific ovarian cancer, genetic linkage has been found to BRCA1 and BRCA2. The lifetime risk of developing ovarian cancer in patients harboring germline mutations in BRCA1 is substantially increased over the general population. Familial cancer, rather than sporadic cancer, tends to occur at a younger age, but the increased risk in carriers of these mutations is life long, and in some carriers bilateral breast cancer or both breast and ovarian cancer develop. BRCA1 mutation carriers have a greater risk than BRCA2 mutations. The effectiveness of the surgical procedure used to reduce the risk of breast cancer and/or ovarian cancer and to improve overall survival is also an important parameter in decision-making between prophylactic bilateral mastectomy and prophylactic bilateral salpingo-oophorectomy in a woman with BRCA1 or BRCA2 mutation. There is no randomized or prospective comparative study between these two surgical procedures, and the data available emerge from retrospective or prospective studies between prophylactic surgery and surveillance. Finch et al in 2006 published the results of a large prospective study of women with the BRCA1 or BRCA2 mutation to estimate the incidence of ovarian, fallopian tube, and primary peritoneal cancer and to estimate the reduction in risk of these cancers associated with a bilateral prophylactic salpingo-oophorectomy. The study included 1,828 BRCA1 and BRCA2 gene mutation carriers participating. Follow-up was for an average of 3.5 years. Five-hundred fifty- five had prophylactic bilateral salpingo-oophorectomy prior to study entry and 490 had the surgery after entry. Results revealed that prophylactic bilateral salpingo-oophorectomy reduced the risk of ovarian and fallopian tube cancer by 80 percent. A residual risk of 4.3 percent for peritoneal cancer remained at 20 years after oophorectomy, but the researchers believe the risk was not sufficiently high to recommend against the surgery. In 2014, Finch et al published the impact of oophorectomy on cancer incidence and mortality in 5783 women with a BRCA1 or BRCA2 mutation. The purpose of the study was to estimate the reduction in risk of ovarian, fallopian tube, or peritoneal cancer in women with BRCA1 or 2 mutation after oophorectomy, by age of oophorectomy; to estimate the impact of prophylactic oophorectomy on all-cause mortality; and to estimate 5 year survival associated with clinically detected ovarian, occult, and peritoneal cancers diagnosed in the cohort. Eligible study participants included women who were carrying a deleterious BRCA1 or BRCA2 mutation and enrolled between 1995 and 2011. A baseline questionnaire was completed and then at least 1 additional questionnaire for a minimum of 2 years. Exclusion criteria were diagnosis of ovarian, fallopian tube, or peritoneal cancer prior to the baseline questionnaire, women carrying both BRCA1 and BRCA2, and oophorectomy before age 20. After an average follow-up period of 5.6 years, 186 women developed either ovarian (n=132), fallopian (n=22), or peritoneal (n=32) cancer, of whom 68 have died. Hazard ratio for ovarian, fallopian, or peritoneal cancer associated with bilateral oophorectomy was 0.20 (95% CI, 0.13 to 0.30; P< .001). Among women who had no history of cancer at baseline, HR for all-cause mortality to age 70 years associated with an oophorectomy was 0.23 (95% CI, 0.13 to 0.39; P<.001). According to the Page 3 of 7 Proprietary Information of Blue Cross and Blue Shield of Alabama An Independent Licensee of the Blue Cross and Blue Shield Association Blue Advantage Medical Policy #259 authors, “the striking finding in this study of BRCA1 or BRCA2 mutation carriers was the effect of oophorectomy on all-cause mortality. Among women who were unaffected with cancer at study entry, risk of death in the follow-up period fell by 77% after oophorectomy.” They go on to state that there is “an important component from reducing breast cancer incidence and mortality as well.” Additionally, an 80% reduction in the risk of ovarian, fallopian tube, or peritoneal cancer in BRCA1 or BRCA2 carriers was found when a preventive oophorectomy was performed. In 2016, Li et al published a meta-analysis and systematic review for the effectiveness of prophylactic surgeries in women with BRCA1/2 mutations. The authors selected 15 studies published between August 2014 and September 1999 for review. The authors state there was a 45% reduction in breast cancer risk and a 65% all-cause mortality associated with prophylactic bilateral salpingo-oophorectomy (PBSO) in women who carry BRCA1/2 mutation with no prior history of breast cancer. PBSO was associated with a 57% reduction in all-cause mortality in breast cancer patients. Limitations of this study were noted to be a limited comparative data on the advantage of prophylactic surgery among BRCA1/2 mutation carriers, and small numbers of BRCA2 mutation carriers in most studies, the age at prophylactic surgery and the follow up periods for participants differed between studies.
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