Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Cancer prevention surgery is surgery done to remove an organ or organs which are believed to be at risk for cancer development. The usual assessment of risk is based on family history and/or genetic testing.

2)    QualChoice recognizes both the trend and the importance of such considerations to individual members who may be affected. This policy is intended to clarify coverage for such surgical procedures.

3)    There is a difference between surgery done in the context of changes in an organ that reflect a pre-cancerous change and surgery done in the absence of any change for the purpose of avoiding the development of cancer.

a)    Once pre-cancerous changes or cancers have been detected, surgical procedures to treat or remove the pre-cancerous or cancerous changes are considered by QualChoice to be a routine part of treatment. These treatments may be subject to preauthorization or review, but they are not the subject of this policy

b)    Surgery that is contemplated in the absence of a cancer and in the absence of any detectable pre-cancerous changes is the subject of this policy.

4)    Most organs are required for vital functions, so removing them for purposes of preventing cancer is not possible. Two organs are frequently considered for removal as a cancer prevention strategy: ovaries and breasts.

5)    Prophylactic oophorectomy and prophylactic mastectomy – the removal of ovaries or breasts for the purpose of preventing cancer – require preauthorization.

PROPHYLACTIC MASTECTOMY

1)    Breast cancer is the most common non-skin cancer in women and ranks second only to lung cancer as a cause of death.  Although there is no known way to absolutely prevent cancer, strategies to reduce the risk of breast cancer are available for high-risk women.  The major options include primary prevention by chemoprevention or prophylactic mastectomy, and secondary prevention by early detection through screening mammography and clinical or self-examination of the breasts.  Regular screening reduces breast cancer mortality by detecting the disease early, but it cannot prevent the disease. 

2)    Women at high risk include the following:

a)    Those women with a strong family history of breast cancer (see paragraph 5 below).

b)    Those women with inherited mutations in one of two breast cancer susceptibility genes (BRCA1 and BRCA2).

c)    Those women with previous cancer in one breast or biopsies showing lobular carcinoma in situ (LCIS).

d)    Those women with atypical hyperplasia of the breast. 

3)    BRCA inheritance has also been linked to an increased risk for ovarian cancer.  Although ovarian cancer is less common than breast cancer, it is substantially more lethal.   (See the section on prophylactic oophorectomy below.)

4)    Atypical hyperplasia of the breast is not considered an indication for prophylactic mastectomy.

5)    QualChoice will cover either prophylactic mastectomy or tamoxifen chemoprevention for reduction of short-term incidence of breast cancer for the following high-risk patients:

a)    Patients with  BRCA1 or BRCA2 mutation confirmed by genetic testing OR

b)    Three or more affected first or second degree relatives on same side of family, irrespective of age at diagnosis; OR

c)    There are fewer than three affected first or second degree relatives, but ANY of the following is met:

i)     There are multiple primary or bilateral breast cancers in the patient or one family member; OR

ii)    A family member has been identified with a detectable mutation; OR

iii)   There are one or more cases of ovarian cancer at any age, AND one or more members on the same side of the family with breast cancer at any age; OR

iv)   There is breast cancer in a male patient, or in a male relative; OR

v)    The patient is at increased risk for specific mutations due to ethnic background (for instance: Ashkenazi Jewish descent) AND has one or more relatives with breast cancer or ovarian cancer at any age; OR

vi)   The patient was diagnosed with breast cancer at 45 years of age or less.

6)    Tamoxifen chemoprevention may be contraindicated in women with any of the following:

a)    Women thought to be at increased risk for thromboembolism (i.e., a history of thromboembolism, hypertension, diabetes, or cigarette smoking); OR

b)    Women who are pregnant or who are planning to become pregnant ; OR

c)    Premenopausal taking oral contraceptives as a method of birth control.

PROPHYLACTIC BILATERAL OOPHORECTOMY

7)    QualChoice covers prophylactic bilateral oophorectomy in patients that have other risk factors including nulliparity, low parity, infertility, early menarche, late menopause, and late first pregnancy, if they meet any ONE of the following criteria:

a)    Patient has completed childbearing and has hereditary ovarian cancer syndrome based on a family pedigree constructed by a physician or genetic counselor.

b)    Patient has personal history of breast cancer and at least one 1st degree relative (e.g., mother, sister, daughter) with a history of ovarian cancer.

c)    Patient has two 1st degree relatives (e.g., mother, sister, daughter) with a history of ovarian cancer.

d)    Patient 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)    Patient has BRCA1 or BRCA2 mutations confirmed by molecular susceptibility testing for breast and/or ovarian cancer.

Codes Used In This BI:

1)    Szabo CI, King MC. Inherited breast and ovarian cancer. Hum Mol Genet. 1995;4 Spec No:1811-1817.

2)    Castilla LH, Couch FJ, Erdos MR, et al. Mutations in the BRCA1 gene in families with early-onset breast and ovarian cancer. Nature Genetics. 1994;8:387-391.

3)    Berchuck A, Cirisano F, Lancaster JM. Role of BRCA1 mutation screening in the management of familial ovarian cancer. Am J Obstet Gynceol. 1996;175:738-746.

4)    Langston AA, Malone KE, Thompson JD, et al. BRCA-1 mutations in a population-based sample of young women with breast cancer. N Engl J Med. 1996;334:137-142.

5)    Fitzgerald MG, MacDonald DJ, Krainer M, et al. Germ-line BRCA1 mutations in Jewish and non Jewish women with early onset breast cancer. N Engl J Med. 1996;334:143-149.

6)    Couch FJ, et al. BRCA1 mutations in women attending clinics that evaluate the risk of breast cancer. N Engl J Med. 1997;336:1409-1415.

7)    Biesecker BB, Boehnke M, Calzone K, et al. Genetic counseling for families with inherited susceptibility to breast and ovarian cancer. JAMA. 1993;269:170-174.

8)    American College of Obstetricians and Gynecologists. Breast-ovarian cancer screening. ACOG Committee Opinion Number 176. Washington, DC:ACOG; October 1996.

9)    Healy B. BRCA genes: book marking, fortune telling, and medical care. NEJM. 1997;336:1448-1449.

10) Krainer M, Silva-Arrieta S, FitzGerald MG, et al. Differential contributions of BRCA1 and BRCA2 to early-onset breast cancer. N Engl J Med. 1997;336:1416-1421.

11) Struewing JP, Hartge P, Wacholder S, et al. The risk of cancer associated with specific mutations of BRCA1 and BRCA2 among Ashkenazi Jews. N Engl J Med. 1997;336:1401-1408.

12) Burke W, Daly M, Garber J, et al. Recommendations for follow-up care of individuals with an inherited predisposition to cancer. JAMA. 1997; 277:997-1003.

13) Ford D, Easton DF, Stratton M, et al. (1998): Genetic heterogeneity and penetrance analysis of the BRCA1 and BRCA2 genes in breast cancer families. Am J Hum Genet. 1998;62:676-689.

14) Puget N. Sinilnikova OM, Stoppa-Lyonnet D, et al. An Alu-medicated 6-kb duplication in the BRCA1 gene: A new founder mutation. Am J Hum Genet. 1999;64:300-302.

15) American Society of Clinical Oncology Statement of the American Society of Clinical Oncology: Genetic testing for cancer susceptibility. J Clin Oncol. 199614:1730-1736.

16) American Society of Human Genetics Ad Hoc Committee on Breast and Ovarian Cancer Screening. Statement of the American Society of Human Genetics on genetic testing for breast and ovarian cancer predisposition. Am J Hum Genet. 1994;55:ii-iv.

17) Weber B. Breast cancer susceptibility genes: Current challenges and future promises. Ann Int Med. 1996;124:1088-1090.

18) Blue Cross Blue Shield Association. Genetic testing for inherited BRCA1 or BRCA2 mutations. Tec Assessment Program Vol. 12 (4). Chicago, IL: Blue Cross Blue Shield Association, 1997.

19) American Medical Association: The role of genetic susceptibility testing for breast & ovarian cancer. Continuing Medical Education Monograph. Chicago, IL: AMA, 1999.

20) American College of Medical Genetics Foundation. Genetic susceptibility to breast and ovarian cancer: assessment, counseling, and testing guidelines. Albany, NY: State of New York, 1999.

21) Heisey RE, Carroll JC, Warner E, et al. Hereditary breast cancer. Identifying and managing BRCA1 and BRCA2 carriers. Can Fam Physician. 1999;45:114-124.

22) Clark BA. Cancer genetics for the clinician: recommendations on screening for BRCA1 and BRCA2 mutations. Cleve Clin J Med. 2000;67(6):408-415.

23) Fasouliotis SJ, Schenker JG. BRCA1 and BRCA2 gene mutations: decision-making dilemmas concerning testing and management. Obstet Gynecol Surv. 2000;55(6):373-384.

24) Bansal A, Critchfield GC, Frank TS, et al. The predictive value of BRCA1 and BRCA2 mutation testing. Genet Test. 2000;4(1):45-48.

25) Solomon JS, Brunicardi CF, Friedman JD. Evaluation and treatment of BRCA-positive patients. Plast Reconstr Surg. 2000;105(2):714-719.

26) Fisher B, Costantino JP, Wickerham DL, et al. Tamoxifen for prevention of breast cancer: report of the National Surgical Adjuvant Breast and Bowel Project P-1 Study. J Natl Cancer Inst. 1998;90(18):1371-1388.

27) Ault A. Tamoxifen prevention claim will not be allowed in USA. Lancet. 1998;352 (9131):883.

28) Katase K, Sugiyama Y, Hasumi K, et al. The incidence of subsequent endometrial carcinoma with tamoxifen use in patients with primary breast carcinoma. Cancer. 1998;82(9):1698-1703.

29) Chang JC. A review of breast cancer chemoprevention. Biomed Pharmacother. 1998;52(3):133-136.

30) Jordan VC, Carbone PP. Preventing breast cancer with tamoxifen. Hosp Pract. 1998;33(9):59-64, 67-68, 71-78.

31) Veronesi U, Maisonneuve P, Costa A, et al. Prevention of breast cancer with tamoxifen: preliminary findings from the Italian randomised trial among hysterectomised women. Italian Tamoxifen Prevention Study. Lancet. 1998;352(9122):93-97.

32) Forbes JF. The control of breast cancer: the role of tamoxifen. Semin Oncol. 1997;24(1 Suppl 1):S1-19.

33) Fisher B, Dignam J, Bryant J, et al. Five versus more than five years of tamoxifen therapy for breast cancer patients with negative lymph nodes and estrogen receptor-positive tumors. J Natl Cancer Inst. 1996 6;88(21):1529-1442.

34) Greenspan EM. Tamoxifen for the prevention of breast cancer. Am J Med. 1996;100(6):665.

35) Fisher B, Costantino JP, Redmond CK, et al. Endometrial cancer in tamoxifen-treated breast cancer patients: findings from the National Surgical Adjuvant Breast and Bowel Project (NSABP) B-14. J Natl Cancer Inst. 1994;86(7):527-537.

36) Morrow M, Jordan VC. Risk factors and the prevention of breast cancer with tamoxifen. Cancer Surv. 1993;18:211-229.

37) Jordan VC. Fourteenth Gaddum Memorial Lecture. A current view of tamoxifen for the treatment and prevention of breast cancer. Br J Pharmacol. 1993;110(2):507-517.

38) Osborne CK. Tamoxifen in the treatment of breast cancer, N Engl J Med. 1998;339(22):1609-1618.

39) Brown PH, Lippman SM. Chemoprevention of breast cancer. Breast Cancer Res Treat. 2000;62(1):1-17.

40) Cuzick J. A brief review of the current breast cancer prevention trials and proposals for future trials. Eur J Cancer. 2000;36(10):1298-1302.

41) Carolin KA, Pass HA. Prevention of breast cancer. Crit Rev Oncol Hematol. 2000;33(3):221-238.

42) Brenner DE. Cancer chemoprevention. Crit Rev Oncol Hematol. 2000;33(3):155-156.

43) Decensi A, Costa A. Recent advances in cancer chemoprevention, with emphasis on breast and colorectal cancer. Eur J Cancer. 2000;36(6):694-709.

44) Kelloff GJ, Crowell JA, Steele VE, et al. Progress in cancer chemoprevention. Ann N Y Acad Sci. 1999;889:1-13.

45) Osborne MP. Chemoprevention of breast cancer. Surg Clin North Am. 1999;79(5):1207-1221.

46) Heerdt AS, Borgen PI. Current status of tamoxifen use: An update for the surgical oncologist. J Surg Oncol. 1999;72(1):42-49.

47) Kotwall CA. Breast cancer treatment and chemoprevention. Can Fam Physician. 1999;45:1917-1924.

48) Unic I, Stalmeier PF, Verhoef LC, et al. Assessment of the time-tradeoff values for prophylactic mastectomy of women with a suspected genetic predisposition to breast cancer. Med Decis Making. 1998;18(3):268-277.

49) Mann GB, Borgen PI. Breast cancer genes and the surgeon. J Surg Oncol. 1998;67(4):267-274.

50) Grann VR, Panageas KS, Whang W, et al. Decision analysis of prophylactic mastectomy and oophorectomy in BRCA1-positive or BRCA2-positive patients. J Clin Oncol. 1998;16(3):979-985.

51) Schrag D, Kuntz KM, Garber JE, et al. Decision analysis--effects of prophylactic mastectomy and oophorectomy on life expectancy among women with BRCA1 or BRCA2 mutations. N Engl J Med. 1997;336(20):1465-1471.

52) Baron RH, Borgen PI. Genetic susceptibility for breast cancer: Testing and primary prevention options. Oncol Nurs Forum. 1997; 24(3): 461-468.

53) van Geel AN, Rutgers EJ, Vos-Deckers GC, et al. Women with hereditary risk of breast cancer: consensus of surgical representatives of study groups for hereditary tumors regarding intensive monitoring, diagnosis and preventive resection. Ned Tijdschr Geneeskd, 1997;141(18):874-877.

54) Burke W, Daly M, Garber J, et al. Recommendations for follow-up care of individuals with an inherited predisposition to cancer. II. BRCA1 and BRCA2. Cancer Genetics Studies Consortium. JAMA. 1997;277(12):997-1003.

55) Lerman C, Narod S, Schulman K, et al. BRCA1 testing in families with hereditary breast-ovarian cancer. A prospective study of patient decision making and outcomes. JAMA. 1996;275(24):1885-1892.

56) Lopez MJ, Porter KA. The current role of prophylactic mastectomy. Surg Clin North Am. 1996;76(2):231-242.

57) Bilimoria MM, Morrow M. The woman at increased risk for breast cancer: evaluation and management strategies. CA Cancer J Clin. 1995;45(5):263-278.

58) Page DL, Dupont WD. Premalignant conditions and markers of elevated risk in the breast and their management. Surg Clin N Amer. 1990; 70: 831-851.

59) Lynch HT, Lynch J, Conway T, et al. Hereditary breast cancer and family cancer syndromes. World J Surg. 1994;18(1):21-31.

60) Hartmann LC, Schaid DJ, Woods JE, et al. Efficacy of bilateral prophylactic mastectomy in women with a family history of breast cancer. N Engl J Med. 1999;340(2):77-84.

61) Newman LA, Kuerer HM, Hung KK, et al. Prophylactic mastectomy. J Am Coll Surg. 2000;191(3):322-330.

62) Vogel VG. Breast cancer prevention: a review of current evidence. CA Cancer J Clin. 2000;50(3):156-170.

63) Schrag D, Kuntz KM, Garber JE, et al. Benefit of prophylactic mastectomy for women with BRCA1 or BRCA2 mutations. JAMA. 2000;283(23):3070-3072.

64) Eisen A, Rebbeck TR, Wood WC, et al. Prophylactic surgery in women with a hereditary predisposition to breast and ovarian cancer. J Clin Oncol. 2000;18(9):1980-1995.

65) Sakorafas GH, Tsiotou AG. Prophylactic mastectomy; evolving perspectives. Eur J Cancer. 2000;36(5):567-578.

66) Solomon JS, Brunicardi CF, Friedman JD. Evaluation and treatment of BRCA-positive patients. Plast Reconstr Surg. 2000;105(2):714-719.

67) Curry P, Fentiman IS. Management of women with a family history of breast cancer. Int J Clin Pract. 1999;53(3):192-196.

68) Bostwick J 3rd, Wood WC. Contra lateral prophylactic mastectomies. Ann Surg Oncol. 1999;6(6):519.

69) Boice JD Jr, Olsen JH. Prophylactic mastectomy in women with a high risk of breast cancer. N Engl J Med. 1999;340(23):1838-1839.

70) Kerlikowske K, Brown JS, Grady DG. Should women with familial ovarian cancer undergo prophylactic oophorectomy?. Obstet Gynecol. 1992;80(4):700-707.

71) Averette HE, Nguyen HN. The role of prophylactic oophorectomy in cancer prevention. Gynecol Oncol. 1994;55(3):S38-S41.

72) Wolff BG. Current status of incidental surgery. Dis Colon Rectum. 1995;38(4):435-441.

73) Meijer WJ, van Lindert CM. Prophylactic oophorectomy. Eur J Obstet Gynecol Reprod Biol. 1992;47(1):59-65.

74) van Eijkeren MA, de Graaff J, van Etten FHPM. Familial ovarian cancer. Eur J Obstet Gynecol Reprod Biol. 1992;47(3):263-266.

75) Evans DGR, Ribiero G, Warrell D, et al.. Ovarian cancer family and prophylactic choices. J Med Genetics. 1992;29(6): 416-418.

76) Schwartz PE. The role of prophylactic oophorectomy in the avoidance of ovarian cancer. Int J Gynecol Obstet. 1992;39(3):175-184.

77) National Institutes of Health. NIH Consensus Development Conference on Ovarian Cancer: Screening, Treatment, and Follow-up. Bethesda, MD: NIH;1994;12(3):4-9.

78) American College of Obstetricians and Gynecologists. Prophylactic oophorectomy. ACOG Technical Bulletin: No 111. Washington, DC:ACOG; 1987.

79) Kerlikowske K, Brown JS, Grady DG. Should women with familial ovarian cancer undergo prophylactic oophorectomy: an editorial reply. Obstet Gynecol: 1993;81(2): 315-316.

80) Speroff T, Dawson NV, Speroff L, Haber RJ. A risk-benefit analysis of elective bilateral oophorectomy: effect of changes in compliance with estrogen therapy on outcome. Am J Obstet Gynecol.164(1, Part 1):165-174.

81) Nguyen HN, Averette HE, Janicek M. Ovarian carcinoma. Cancer. 1994;74(2):545-555.

82) Sightler SE, Bioke GM, Estape RE, Averettte HE. Ovarian cancer in women with prior hysterectomy: a 14-year experience at the University of Miami. Obstet Gynecol. 1992;78(4):681-684.

83) Reiter RC, Gambone JC. Editorial reply to Ovarian cancer in women with prior hysterectomy: a 14-year experience at the University of Miami. Obstet Gynecol.1992;79(2):317-319

84) Lu KH Garber JE, Cramer DW, et al. Occult ovarian tumors in women with BRCA1 or BRCA2 mutations undergoing prophylactic oophorectomy. J Clin Oncol. 2000;18(14):2728-2732.

85) Gotlieb WH, Baruch GB, Friedman E. Prophylactic oophorectomy: clinical considerations. Semin Surg Oncol. 2000;19(1):20-27.

86) Farghaly SA. Current status of management of hereditary ovarian-breast cancer syndrome. Obstet Gynecol. 2000;95(4 Suppl 1):S51.

87) American College of Obstetrics and Gynecology. Prophylactic oophorectomy. ACOG Practice Bulletin No 7. Washington, DC: ACOG; September 1999 (replaces Technical Bulletin No 111, December 1987).

88) Clinical management guidelines for obstetrician-gynecologists. American College of Obstetricians and Gynecologists. Int J Gynaecol Obstet. 1999;67(3):193-199.

89) Berchuck A, Schildkraut JM, Marks JR, Futreal PA. Managing hereditary ovarian cancer risk. Cancer. 1999;86(11 Suppl):2517-2524.

90) Eisinger F, Alby N, Bremond A, et al. Inserm ad hoc committee: Recommendations for the management of women with a genetic risk for developing cancer of the breast and/or the ovary. Bull Cancer. 1999;86(3):307-313.

91) Rebbeck TR. Prophylactic Oophorectomy in BRCA1 and BRCA2 mutation carriers. J Clin Oncol. 2000;18(90001):100S-103S.

92) Eisen A, Rebbeck TR, Wood WC, Weber BL. Prophylactic surgery in women with a hereditary predisposition to breast and ovarian cancer. J Clin Oncol. 2000;18(9):1980-1995.

93) Rebbeck TR, Levin AM, Eisen A, et al. Breast cancer risk after bilateral prophylactic oophorectomy in BRCA1 mutation carriers. J Natl Cancer Inst. 1999;91(17):1475-1479.

94) Kauff ND, et al. Risk-reducing salpingo-oophorectomy in women with a BRCA1 or BRCA2 mutation. N Engl J Med. 2002;346:1609-1615.

95) Rebbeck TR, et al. Prophylactic oophorectomy in carriers of BRCA1 or BRCA2 mutations. N Engl J Med 2002;346:1616-1622.

96) Haber D. Prophylactic oophorectomy to reduce the risk of ovarian and breast cancer in carriers of BRCA mutations. N Engl J Med. 2002;346:1660-1662.

This policy applies to all health plans and products administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet.  Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) or Certificate of Coverage (COC) for those plans or products insured by QualChoice.  In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC or COC, the SPD,  EOC, or COC, as applicable, will prevail.  State and federal mandates will be followed as they apply.