Subject:
Risk-Reducing Salpingo-Oophorectomy
Description:
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IMPORTANT NOTE:
The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.
Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.
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Risk-reducing Salpingo-Oophorectomy (RRSO) is the removal of both fallopian tubes and ovaries for the potential benefit of preventing the development of ovarian cancer in women who are at risk for the disease.
Policy:
[Please note that when oophorectomy is performed as a 'surgical' (versus 'medical') management to primarily achieve ovarian suppression, it is considered therapeutic and not prophylactic. ]
(NOTE: For Medicare Advantage, Medicaid and FIDE-SNP, please refer to the Coverage Sections below for coverage guidance.)
1. Risk-reducing Salpingo-Oophorectomy (RRSO) is considered medically necessary in selected members who meet any of the following lettered criteria:
A. For women with a BRCA1 and/or BRCA2 pathogenic/likely pathogenic variant positive, recommend risk-reducing salpingo-oophorectomy (RRSO) typically between age 35-40, and upon completion of childbearing.
(NOTE: Because ovarian cancer in patients with BRCA2 pathogenic/likely pathogenic variants develop cancer an average of 8-10 years later than in patients with the BRCA1 gene variant, it is reasonable to delay RRSO for management of ovarian cancer risk until age 40-45 y in those members with the BRCA2 pathogenic/likely pathogenic variants unless age at diagnosis within the family warrants earlier age for consideration of prophylactic surgery.)
B. Member's family history is consistent with hereditary ovarian cancer syndrome based on a family pedigree constructed by a physician or genetic counselor competent in determining the presence of autosomal dominant inheritance pattern.
(NOTE: The three hereditary ovarian cancer syndromes are: (1) Familial breast-ovarian cancer syndrome - occurs in families with clusters of women with ovarian cancer and/or breast cancer; (2) Familial site-specific ovarian cancer syndrome - occurs in families with clusters of ovarian cancer; and (3) Hereditary non-polyposis colorectal cancer syndrome or Lynch Syndrome II - a familial cancer syndrome characterized by an inherited predisposition to the development of early onset (usually ages 40 to 50) colorectal cancer, endometrial cancer, breast cancer, genito-urinary cancer,and ovarian cancer.
A family pedigree constructed by a physician or genetic counselor, competent in determining the presence of autosomal dominant inheritance pattern, is the primary diagnostic tool in differentiating hereditary ovarian syndromes from nonhereditary ovarian cancer. The probability of hereditary ovarian cancer syndrome increases as the number of first degree relatives increases, the total number of affected relatives increases, the number of generations affected increases, and with the diagnosis of ovarian cancer at a young age.)
C. Member has two 1st degree relatives (e.g., mother, sister, daughter) with a history of ovarian cancer.
D. Member has one 1st degree relative (e.g., mother, sister, daughter) and one or more 2nd degree relatives (maternal or paternal aunt or grandmother) with ovarian cancer.
E. Member has a personal history of breast cancer and at least one 1st degree relative (i.e., mother, sister, daughter) with a history of ovarian cancer.
F. BRIP1, RAD51C, RAD51D : Risk-reducing salpingo-oophorectomy (RRSO) in BRIP1, RAD51C or RAD51D mutation carriers may be considered at 45-50 years of age
(NOTE: The lifetime risk of ovarian cancer in carriers of pathogenic/likely pathogenic variants on BRIP1 , RAD51C and RAD51D appear sufficient to justify RRSO. The current evidence is not sufficient to make a firm recommendation as to the optimal age for the procedure to be performed. Based on limited evidence, discussions about surgery should be held around age 45-50, or earlier if there is a family history of earlier onset ovarian cancer.)
G. In pre-menopausal women with estrogen receptor (ER) positive breast cancer, in conjunction with neoadjuvant endocrine therapy, RROS may be considered medically necessary .
(NOTE: NCCN recommends either surgical oophorectomy or ovarian radiation as methods of ovarian ablation, or luteinizing hormone-releasing hormone (LHRH) agonists for ovarian suppression in conjunction with neoadjuvant endocrine therapy (i.e., tamoxifen) .).
[INFORMATIONAL NOTE: It is recommended that the member consult a certified genetic counselor prior to the procedure to discuss the member's risk status for ovarian cancer, and the potential benefits and risks associated with Risk-reducing Salpingo-Oophorectomy (RRSO).]
2. Documentation of medical necessity must include:
- detailed history and physical examination
- detailed family history (refer to NOTE under policy statement 1.B.)
- laboratory reports (as deemed appropriate)
3. Risk-reducing Salpingo-Oophorectomy (RRSO) is not considered medically necessary for cancerphobia.
Medicare Coverage:
There is no National Coverage Determination (NCD) for Risk-reducing Salpingo-Oophorectomy (RRSO). In the absence of an NCD, coverage decisions are left to the discretion of Local Medicare Carriers. Novitas Solutions, Inc, the Local Medicare Carrier for jurisdiction JL, has not issued a determination for this service. Therefore, Medicare Advantage Products will follow the Horizon BCBSNJ Medical Policy.
In addition, per LCD BRCA1 and BRCA2 Genetic Testing (L36715), a risk-reducing salpingo-oophorectomy may be considered even with insufficient evidence from the following tests, BRIP1, ATM, CHEK2, STK11, or PALB2. Intervention may still be warranted based on family history or other clinical factors. For additional information, refer to Local Coverage Determination (LCD):BRCA1 and BRCA2 Genetic Testing (L36715). Available at: Available to be accessed at Novitas Solutions, Inc., Medical Policy Search page: https://www.novitas-solutions.com/webcenter/portal/MedicareJL/pagebyid?contentId=00024370.
Medicaid Coverage:
For members enrolled in Medicaid and NJ FamilyCare plans, Horizon BCBSNJ applies the above medical policy.
FIDE-SNP Coverage:
For members enrolled in a Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP): (1) to the extent the service is covered under the Medicare portion of the member’s benefit package, the above Medicare Coverage statement applies; and (2) to the extent the service is not covered under the Medicare portion of the member’s benefit package, the above Medicaid Coverage statement applies.
[INFORMATIONAL NOTE:
Practice Guidelines and Position Statements
National Comprehensive Cancer Network (NCCN) Guidelines (Version 3.2019) on Genetic/Familial High-Risk Assessment: Breast and Ovarian, state the following Ovarian Management based on genetic test results:
The following genes and others are found on some of the panels but there is insufficient evidence to make any recommendations for breast MRI, RRSO, or Risk-reducing Mastectomy (RRM): BARD1, FANCC, MRE11A, MUTYH heterozygotes, RECQL4, RINT1, SLX4, SMARCA4, or XRCC2.
The decision to undergo RRSO is a complex one and should be made ideally in consultation with a gynecologic oncologist, especially when the patient wishes to undergo RRSO before the age at which it is typically recommended (i.e., 35 years of age). Topics that should be addressed include impact on reproduction, impact on breast and ovarian cancer risk, risks associated with premature menopause (e.g., osteoporosis, cardiovascular disease, cognitive changes, changes to vasomotor symptoms, sexual concerns), and other medical issues. The panel recommends that a gynecologic oncologist help patients considering RRSO understand how it may impact quality of life.
Limited data suggest there may be a slightly increased risk of serous uterine cancer among women with a BRCA1 pathogenic/likely pathogenic variant. The clinical significance of these findings is unclear. Further evaluation of the risk of serous uterine cancer in the BRCA population needs to be undertaken. The provider and member should discuss the risks and benefits of concurrent hysterectomy at the time of RRSO for women with a BRCA1 pathogenic/likely pathogenic variant prior to surgery.]
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Horizon BCBSNJ Medical Policy Development Process:
This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.
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Index:
Risk-Reducing Salpingo-Oophorectomy
RRSO
Prophylactic Oophorectomy
Oophorectomy, Prophylactic
References:
1. Matloff ET, Shappel H, Brierley K, et al. What would you do? Specialists' perspectives on cancer genetic testing, prophylactic surgery, and insurance discrimination. Journal of Clinical Oncology. June 2000;18(12):2482-2492.
2. Schrag D, Kuntz K, et al. Life expectancy gains from cancer prevention strategies of women with breast cancer and BRCA1 or BRCA2 mutation. Journal of the American Medical Association. February 2000;283(5):617-624.
3. ACOG Practice Bulletin: Prophylactic Oophorectomy. Number 7. September 1999. International Journal Gynecology & Obstetrics. 1999;67:193-199.
4. Deligdisch L, Gil J, Kerner H, et al. Ovarian dysplasia in prophylactic oophorectomy specimens. Cancer. October 1999;86(8):1544-1550.
5. Schrag D, Kuntz KM, et al. Effects of prophylactic mastectomy and oophorectomy on life expectancy among women with BRCA1 or BRCA2 mutations. New England Journal of Medicine. 1997;336(20):1465-1471.
6. Nguyen HN, Averette HE, et al. Ovarian Carcinoma: A review of the significance of familial risk factors and the role of prophylactic oophorectomy in cancer prevention. Cancer. July 1994;74(2):545-555.
7. Ngan HY, Shepherd JH. Familial ovarian cancer. British Journal of Hospital Medicine. July 1994;52(2-3):99-102.
8. NIH Consensus Statement Online on Ovarian Cancer: Screening, Treatment, and Follow-Up. April 5-7, 1994;12(3):1-30.
9. Kerlikowske K, Brown JS, Grady DG. Should women with familial ovarian cancer undergo prophylactic oophorectomy? Obstetrics and Gynecology. 1992;80:700-707.
10. Schildkraut JM, Thompson WD. Familial ovarian cancer: a population-based case control study. American Journal of Epidemiology. 1988;128:456-466.
11. Kauff ND, Satagopan JM, Robson ME et al. Risk-reducing salpingo-oophorectomy in women with a BRCA1 or BRCA2 mutation. N Engl J Med. 2002 May 23;346(21):1609-15.
12. Rebbeck TR, Lynch HT, Neuhausen SL et al. Prophylactic oophorectomy in carriers of BRCA1 or BRCA2 mutations. N Engl J Med. 2002 May 23;1616-22.
13. Haber D. Prophylactic oophorectomy to reduce the risk of ovarian and breast cancer in carriers of BRCA mutations. N Engl J Med. 2002 May 23;346(21):1660-2.
14. National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology - Genetic/Familial High-Risk Assessment: Breast and Ovarian. Version 1.2007, 03/22/07 (accessed 03/19/08).
15. ECRI. TARGET Report #825: Bilateral prophylactic oophorectomy (BPO) for women at high risk of ovarian cancer. Content current as of: August, 2002. (last accessed 03/03/07)
16. Agency for Healthcare Research and Quality. Evidence Synthesis # 37: Genetic risk assessment and BRCA mutation testing for breast and ovarian cancer susceptibility: Evidence Synthesis. September 2005.
17. American Cancer Society. Detailed Guide: Ovarian Cancer. Can ovarian cancer be prevented?. Revised 01/19/2008. [Available at: http://www.cancer.org/docroot/CRI/content/CRI_2_4_2X_Can_ovarian_cancer_be_prevented_33.asp (last accessed 03/19/08).]
18. 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. 2006 Jul 12;296(2):185-92.
19. Domchek SM, Rebbeck TR. Prophylactic oophorectomy in women at increased risk. Curr Opin Obstet Gynecol. 2007 Feb;19(1):27-30.
20. ECRI Institute. Health Technology Assessment Information Service (HTAIS). Custom Hotline Response: Genetic Testing for BRCA1 and BRCA2 Mutations for Assessing Ovarian Cancer Risk. Updated 02/16/2006.
21. Fader AN, Rose PG. Role of surgery in ovarian carcinoma. J Clin Oncol 2007 Jul 10;25(20):2873-83.
22. Love RR, Uy GB. Surgical oophorectomy for breast cancer: back to the future. Future Oncol 2008 Dec;4(6):785-92.
23. Love RR, Van Dinh N, Quy TT, et al. Survival after adjuvant oophorectomy and tamoxifen in operable breast cancer in premenopausal women. J Clin Oncol 2008 Jan 10;26(2):253-7.
24. National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology - Breast Cancer. Version 3.2014. 04/01/14 (accessed 11/19/14).
25. ACOG Practice Bulletin No. 89: Elective and Risk-Reducing Salpingooophorectomy. (Replaces Practice Bulletin Number 7, September 1999). Obstetrics and Gynecology. January 2008;111(1):231.
26. National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology - Genetic/Familial High-Risk Assessment: Breast and Ovarian. Version 2.2014. 09/23/14 (accessed 11/19/14).
27. UpToDate. Risk-reducing bilateral salpingo-oophorectomy in women at high risk of epithelial ovarian and fallopian tubal cancer. Literature review current through September 2016. Topic last updated September 17, 2015.
28. Finch AP, Lubinski J, Moller P et al. Impact of oophorectomy on cancer incidence and mortality in women with a BRCA1 or BRCA2 mutation. J Clin Oncol. 2014 May 20;32(15):1547-53.
29. McCann GA, Eisenhauer EL. Hereditary cancer syndromes with high risk of endometrial and ovarian cancer: surgical options for personalized care. J Surg Oncol. 2015 Jan;111(1):118-24.
30. Garcia C, Powell CB. A comprehensive approach to the identification and management of the BRCA patient. Obstet Gynecol Surv. 2015 Feb;70(2):131-43.
31. van der Aa JE, Hoogendam JP, Butter ES, et al. The effect of personal medical history and family history of cancer on the uptake of risk-reducing salpingo-oophorectomy. Fam Cancer. 2015 Dec;14(4):539-44.
32. Drescher CW, Beatty JD, Resta R, et al. The effect of referral for genetic counseling on genetic testing and surgical prevention in women at high risk for ovarian cancer: Results from a randomized controlled trial. Cancer 2016 Jul 22 [Epub ahead of print]
33. Ludwig KK, Neuner J, Butler A, et al. Risk reduction and survival benefit of prophylactic surgery in BRCA mutation carriers, a systematic review. Am J Surg 2016 Jul 18 [Epub ahead of print]
34. Reed SD, Goff B. Elective oophorectomy or ovarian conservation at the time of hysterectomy. In: UpToDate, Sharp ST, Falk SJ (Eds), UpToDtae, Waltham, MA. (Accessed October 6, 2017.)
35. National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology - Genetic/Familial High-Risk Assessment: Breast and Ovarian. Version 1.2018. 10/03/17 (accessed 10/16/17).
36. National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology - Genetic/Familial High-Risk Assessment: Breast and Ovarian. Version 2.2019. 07/30/18 (accessed 09/07/2018).
37. National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology - Genetic/Familial High-Risk Assessment: Breast and Ovarian. Version 3.2019. January 18, 2019 (accessed 02/05/2019).
38. National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology - Genetic/Familial High-Risk Assessment: Breast and Ovarian. Version 3.2019. January 18, 2019 (accessed 08/26/2019).
39. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). Breast Cancer. Version5.2020 - July 15, 2020. (Accessed August 25, 2020).
Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)
CPT*
HCPCS
* CPT only copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.
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Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.
The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy
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