mp-259 - mp-259 - Medical Policies
Policy Number: MP-259
Latest Review Date: February 2022
Prophylactic oophorectomy or salpingo-oophorectomy may be considered medically necessary 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 medical policy #426.
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.
A literature search was performed through February 7, 2022.
Summary of Evidence
For women that receive prophylactic oophorectomy or prophylactic salpingo-oophorectomy for a personal history of breast cancer, BRCA mutation, first degree relatives or first/second degree relatives (as indicated in policy statement), the evidence consists of meta-analyses, prospective studies, and retrospective studies. 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. The available literature indicates that prophylactic bilateral salpingo-oophorectomy reduced the risk of ovarian and fallopian tube cancer up to 80 percent. A meta-analysis performed in 2016 states that there is “an important component from reducing breast cancer incidence and mortality as well.” The evidence is sufficient to determine the technology results in an improvement in health outcome.
For women that receive prophylactive oophorectomy or salpingo-oophorectomy who have a strong family history of colon cancer in first/second degree relatives, or known familial cancer syndrome associated with increased risk of ovarian cancer (e.g. Lynch Syndrome), the evidence consists of prospective studies, retrospective reviews, and cohort studies. Women with Lynch syndrome have a 40-60% lifetime risk of developing endometrial cancer, a 10 to 12% risk of developing ovarian cancer and an increased risk of developing a second primary colorectal cancer. Studies show that prophylactic oophorectomy/salpingo-oophorectomy reduces the risk of ovarian cancer in women with Lynch Syndrome. One study included 315 women with documented germ-line mutations associated with Lynch Syndrome. Sixty-one women had undergone prophylactic hysterectomy and 47 women undergone prophylactic bilateral salpingo-oophorectomy were matched with 210 mutation positive women who had not undergone prophylactic surgery. These matched controls were followed from the date of the surgery until the occurrence of cancer or until the data were censored at the time of the last follow-up visit. There were no occurrences of endometrial, ovarian, or primary peritoneal cancer among those who had undergone prophylactic surgery. Endometrial cancer was diagnosed in 69 women (33%) in the control group for an incidence density of 0.045 per woman-year, Ovarian cancer was diagnosed in 12 women (5%) in the control group for an incidence density of 0.005 per woman-year. Their findings suggest that prophylactic hysterectomy with bilateral salpingo-oophorectomy is an effective strategy for preventing endometrial and ovarian cancer with the Lynch Syndrome. The evidence is sufficient to determine the technology results in an improvement in health outcome.
Practice Guidelines and Position Statements
The American College of Obstetricians and Gynecologists (ACOG)
ACOG updated their Practice Bulletin regarding Hereditary Breast and Ovarian Cancer Syndrome (Number 182, September 2017). ACOG recommends the following:
- Women with BRCA mutations or who carry another actionable deleterious mutation predisposing to ovarian cancer should be offered risk-reducing bilateral salpingo-oophorectomy. The timing of risk-reducing bilateral salpingo-oophorectomy can be individualized based on the particular genetic mutation, the patient’s desires for future childbearing and family history. Typically, risk-reducing salpingo-oophorectomy is recommended at age 35–40 years for BRCA1 carriers with the highest lifetime risk of ovarian cancer, whereas women with BRCA2 may consider delaying until age 40–45 years because of later onset of ovarian cancer. (LOE B)
- In women with BRCA mutations or who have a personal or family history of ovarian cancer, routine ovarian cancer screening with measurement of serum CA 125 level or transvaginal ultrasonography generally is not recommended. Transvaginal ultrasonography or measurement of serum CA 125 level may be reasonable for short-term surveillance in women at high risk of ovarian cancer starting at age 30–35 years until the time they choose to pursue risk-reducing bilateral salpingo-oophorectomy, which is the only proven intervention to reduce ovarian cancer-specific mortality.
ACOG also published a practice bulletin in 2014 related to Lynch Syndrome. They recommend:
- Prophylactic hysterectomy and bilateral salpingo-oophorectomy is a risk reducing option for women with Lynch syndrome who have completed child bearing. In general, risk reducing hysterectomy and salpingo-oophorectomy should be discussed with the patient by their early to mid 40s.
The Society of Gynecologic Oncology
In 2015, the Society of Gynecologic Oncology recommended the following regarding prophylactic oophorectomy/salpingo-oophorectomy:
- Risk reducing salpingo-oophorectomy (RRSO) between the ages of 35-40 years is recommended for risk reduction in women at increased genetic risk of ovarian cancer. The age of RROS may also be individualized according to the earliest age of onset in they family and personal choices.
- Salpingectomy can be considered at the completion of childbearing in women at increased genetic risk of ovarian cancer who do not agree to salpingo‐oophorectomy. However, this is not a substitute for oophorectomy, which should still be performed as soon as the woman is willing to accept menopause, preferably by the age of 40 years. Women delaying or refusing risk‐reducing oophorectomy will not receive the breast cancer risk reduction provided by oophorectomy.
- Salpingectomy can be considered in average‐risk women undergoing hysterectomy, other pelvic surgery, and sterilization at the completion of childbearing.
U.S. Preventive Services Task Force Recommendations
BRCA1, BRCA2, prophylactic bilateral oophorectomy, prophylactic bilateral salpingo-oophorectomy, ovarian cancer, breast cancer; Lynch Syndrome, HNPCC
APPROVED BY GOVERNING BODIES:
Coverage is subject to member’s specific benefits. Group specific policy will supersede this policy when applicable.
ITS: Home Policy provisions apply
FEP contracts: FEP does not consider investigational if FDA approved and will be reviewed for medical necessity. Special benefit consideration may apply. Refer to member’s benefit plan.
Laparoscopy, surgical; with lysis of adhesions with removal of adnexal structures (partial or total oophorectomy and/or salpingectomy)
Salpingo-oophorectomy, complete or partial, unilateral or bilateral (separate procedure)
Oophorectomy, partial or total, unilateral or bilateral;
- American Cancer Society. About and Key Statistics. https://www.cancer.org/cancer/ovarian-cancer.html. Accessed March 2018.
- American College of Obstetricians and Gynecologists. ACOG practice bulletin: Hereditary breast and ovarian cancer syndrome. Number 182, September 2017. https://www.sgo.org/wp-content/uploads/2012/09/PB-182.pdf.
- American College of Obstetricians and Gynecologists. ACOG practice bulletin: Lynch syndrome. Number 147, November 2014.
- Debniak T, Gromowski T, Scott RJ et al. Management of ovarian and endometrial cancers in women belonging to HNPCC carrier families: review of the literature and results of cancer risk assessment in polisy HNPCC families. Hered Cancer Clin Pract. 2015 Jan 16; 13(1):3.
- Finch A, Beiner M, Lubinski J, et al. Salpingo-oophorectomy and the risk of ovarian, fallopian tube, and peritoneal cancers in women with a BRCA1 or BRCA2 mutation. JAMA, July 2006, Vol. 296, No. 2, pp. 185-192.
- Finch A, Lubinski J, Moller P et al. Impact of oophorectomy on cancer incidence and mortality in women with a BRCA1 or BRCA2 mutation. Journal of clinical oncology. 2014 May 20, 32(15) 1547-1552.
- IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
- Levin B, Lieberman DA, McFarland B, et al. Screening and surveillance for the early detection of colorectal cancer and adenomatous polyps, 2008: A joint guideline from the American Cancer Society, the US multi-society task force on colorectal cancer, and the American College of Radiology. CA Cancer J Clin, May/June 2008, Vol. 58, No. 3.
- 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 Aug 1; 22(15):3971-81.
- Meijers-Heijboer Hanne, et al. Use of genetic testing and prophylactic mastectomy and oophorectomy in women with breast or ovarian cancer from families with a BRCA1 or BRCA2 mutation. Journal of Clinical Oncology, May 2003, Vol. 21, Issue 9, pp. 1675-1681.
- National Cancer Institute. Ovarian, fallopian tube, and primary peritoneal cancer prevention (PDQ®) – Health Professional Version. https://www.cancer.gov/types/ovarian/hp/ovarian-prevention-pdq. Accessed March 2018.
- National Cancer Institute. Ovarian epithelial cancer (PDQ®): Treatment health professional version, June 2005.
- National Guideline Clearinghouse. Prophylactic oophorectomy, www.guideline.gov/summary/summary.aspx?ss=15&doc_id=3958&nbr=3095.
- Olufunmilayo I, et al. Efficacy of risk-reducing salpingo-oophorectomy in women with BRCA-1 and BRCA-2 mutations. The Breast Journal, January 2004, Vol. 10, Issue S1, p. S5.
- Rebbeck Timothy R, Lynch Henry T, Neuhausen Susan L, et al. Prophylactic oophorectomy in carriers of BRCA1 or BRCA2 mutations. The New England Journal of Medicine, May 2002.
- Roukos Dimitrios H, Agnanti Niki J, et al. Approaching the dilemma between prophylactic bilateral mastectomy or oophorectomy for breast and ovarian cancer prevention in carriers of BRCA1 or BRCA2 mutations. Annals of Surgical Oncology 2002; 9: 941-943.
- Schmeler KM, Lynch HT, et al. Prophylactic surgery to reduce the risk of gynecologic cancers in the Lynch Syndrome. NEJM, January 2006; 354(3): 261-269.
- Schrag Deborah, Kuntz Karen, et al. Decision analysis – Effects of prophylactic mastectomy and oophorectomy on life expectancy among women with BRCA1 or BRCA2 mutations. The New England Journal of Medicine, May 1997, Vol., 336, No. 20, pp. 1465-1471.
- Society of Gynecologic Oncology. https://www.sgo.org/. Accessed March 2018.
- Umar A, Risinger JI, Hawk ET and Barrett JC. Testing guidelines for hereditary non-polyposis colorectal cancer. Nature Reviews Cancer, February 2004, www.medscape.com/viewarticle/468147_print. Accessed October 12, 2009.
- Walker JL, Powell CB, Chen L, et al. Society of gynecologic oncology recommendations for the prevention of ovarian cancer. Cancer, 27 March 2015. 121(13):2108-2120.
Medical Policy Group, December 2005 (1)
Medical Policy Administration Committee, January 2006
Available for comment January 28-March 13, 2006
Medical Policy Group, December 2007 (1)
Medical Policy Group, November 2009 (1)
Medical Policy Administration Committee, November 2009
Available for comment November 6-December 21, 2009
Medical Policy Group, September 2012 (3): Effective September 14, 2012 this policy is no longer scheduled for regular literature reviews and updates.
Medical Policy Group, March 2018 (4): Updates to Description, Key Points, Key Words, and References.
Medical Policy Group, August 2019 (7): Clarification to Policy Statement verbiage- added “salpingo-oophorectomy”. No change in intent.
Medical Policy Group, February 2021 (4): Updates to Key Points and References. No change to policy statement.
Medical Policy Group, February 2022 (4): Reviewed by consensus. Reference added. No new published peer-reviewed literature available that would alter the coverage statement in this policy.
This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.
The plan 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. The plan administers benefits based on the member’s contract and corporate 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.
As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.
The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:
1. The technology must have final approval from the appropriate government regulatory bodies;
2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;
3. The technology must improve the net health outcome;
4. The technology must be as beneficial as any established alternatives;
5. The improvement must be attainable outside the investigational setting.
Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:
1. In accordance with generally accepted standards of medical practice; and
2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and
3. Not primarily for the convenience of the patient, physician or other health care provider; and
4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.