Download Genetic Testing-BRCA

MEDICAL PRE-AUTHORIZATION CRITERIA
PROCEDURE/
EQUIPMENT
Genetic Testing, BRCA 1 & 2
CPT/HCPCS
CODES
81162, 81211, 81212, 81213, 81214, 81215, 81216, 81217
CRITERIA FOR
BRCA 1 AND 2
COMPREHENSIVE
SEQUENCE
ANALYSIS,
FOUNDER
MUTATIONS
MUST MEET ALL OF THE FOLLOWING:
1. The results of the genetic testing will directly impact surveillance or treatment of the
member.
2. One of the following criteria is met:
a. Three or more close relatives1 (including the member) on the same side of the family
have breast (either invasive or non-invasive) or ovarian cancer (includes epithelial
ovarian/fallopian tube/primary peritoneal cancers), irrespective of the age at
diagnosis.
b. There are fewer than three close relatives on the same side of the family with breast
or ovarian cancer, but any of the following are present:
1) The member or a close relative was diagnosed with breast cancer at ≤ 45 years
of age;
2) A close relative has been identified with a detectable BRCA 1 or 2 mutation;
3) The member or a close relative was diagnosed with breast cancer ≤ 50 years of
age and one of the following:
a) ≥ 1 close relative was diagnosed with breast cancer at any age;
b) ≥ 1 close relative with pancreatic cancer;
c) ≥ 1 close relative with prostate cancer (Gleason score ≥ 7);
d) two primary breast cancers (including bilateral disease or two or more
separate primary tumors in the same breast);
e) there is an unknown or limited family history.2
4) The member was diagnosed with breast cancer at any age and one of the
following:
a) ≥ 1 close relative was diagnosed with breast cancer ≤ 50 years of age;
b) ≥ 2 close relatives with breast cancer at any age;
c) ≥ 2 close blood relatives with pancreatic cancer and/or aggressive prostate
cancer (Gleason score ≥ 7) at any age.
5) The member or a close relative was diagnosed with triple negative breast cancer
≤ 60 years of age.3
6) The member or a close relative was diagnosed with ovarian cancer, fallopian
tube or primary peritoneal cancer at any age.
7) The member or a close relative with breast cancer is male.
8) The member or a close relative was diagnosed with breast cancer at any age
and is at increased risk for specific mutation(s) due to ethnic background (for
instance: Ashkenazi Jewish descent).4
c. The member or a close relative was diagnosed with pancreatic cancer at any age
with ≥ 1 close relative with ovarian cancer at any age or breast cancer ≤ 50 or two
relatives with breast, pancreatic or prostate cancer (Gleason score ≥ 7) at any age.
d. The member or a close relative was diagnosed with prostate cancer (Gleason score
≥7) at any age with ≥ 1 close relative with ovarian cancer at any age or breast
cancer ≤ 50 or two close relatives with breast, pancreatic or prostate cancer
(Gleason score ≥ 7) at any age.
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technologies, go to
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Medical Pre-Authorization Criteria
Genetic Testing, BRCA 1 & 2 (BRAC Analysis)
Page 1 of 4
MEDICAL PRE-AUTHORIZATION CRITERIA
CRITERIA FOR
BRCA 1 AND 2
COMPREHENSIVE
SEQUENCE
ANALYSIS,
FOUNDER
MUTATIONS
(continued)
e. A third-degree relative has breast and/or ovarian cancer (including fallopian tube or
primary peritoneal cancer) and who has ≥ two close relatives with breast cancer (at
least one with breast cancer ≤ 50) and/or ovarian cancer.
1
A close relative is defined as a 1st, 2nd or 3rd degree relative (a parent, full sibling, half sibling, child,
grandparent, great-grandparent, grandchild, aunt, great aunt, uncle, great uncle, nephew, niece, or first
cousin).
2
A limited family history is defined as fewer than two first- or second-degree female relatives or female
relatives surviving beyond 45 years in either lineage (maternal and paternal).
3
Breast cancer that is negative for Estrogen receptor (ER), Progesterone receptor (PR) and HER2.
4
Authorization will initially be for the mutation(s) specific for the ethnic group in question (Multisite 3
BRACAnalysis® or equivalent testing for Founder Mutations). If the initial screening is negative, the
member should be authorized for additional genetic testing (Comprehensive Sequence Analysis) only if
he/she meets the remainder of the criteria.
CRITERIA FOR
BRCA 1 AND 2
DUPLICATION/
DELETION
ANALYSIS,
UNCOMMON
VARIANTS
MUST MEET THE FOLLOWING:
1.
The member meets criteria for Comprehensive Sequence Analysis; the analysis has
been completed and is negative.
REFERENCES
1.
U. S. Preventive Services Task Force.Risk Assessment, Genetic Counseling, and
Genetic Testing for BRCA-Related Cancer in Women November 2014. Accessed at
http://ahrq.gov/clinic/uspstf/uspsbrgen.htm.
2.
Armstrong K, Eisen A, Weber B. Assessing the risk of breast cancer. N Engl J Med.
2000 Feb;342(8):564-571.
3.
Gradishar WJ, Anderson BO, Balassanian R, et al. Breast cancer. National
Comprehensive Cancer Network clinical practice guidelines in oncology.2016;Version
2. Accessed at www.nccn.org/professionals/physician_gls/PDF/breast.pdf.
4.
Bevers TB, Helvie, M, Bonnacio E, et al. Breast cancer screening and diagnosis.
National Comprehensive Cancer Network clinical practice guidelines in oncology. 2015;
Version 1.. Accessed at www.nccn.org/professionals/physician_gls/PDF/breastscreening.pdf.
5.
Daly MB, Pilarski R, Axelbund JE, et al. Genetic/Familial high risk assessment: Breast
and ovarian. National Comprehensive Cancer Network clinical practice guidelines in
oncology.2016; Version 2. Accessed at
www.nccn.org/professionals/physician_gls/PDF/genetics_screening.pdf.
6.
Breast Cancer Susceptibility 1 and 2 (BRCA 1/2) Gene Testing for Hereditary Breast
and Ovarian Cancer (HBOC). Hayes GTE Report. Winifred S. Hayes, Inc. August 6,
2013; updated July 20, 2015.
7.
Agata S, Viel A, Della Puppa L, et al. Prevalence of BRCA1 genomic rearrangements
in a large cohort of Italian breast and breast/ovarian cancer families without detectable
BRCA1 and BRCA2 point mutations. Genes Chromosomes Cancer. 2006
Sep;45(9):791-797.
To view ConnectiCare’s list of policies on various medical treatments and emerging
technologies, go to
www.connecticare.com/provider/MedicalPolicyCriteria.aspx
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Medical Pre-Authorization Criteria
Genetic Testing, BRCA 1 & 2 (BRAC Analysis)
Page 2 of 4
MEDICAL PRE-AUTHORIZATION CRITERIA
REFERENCES
8.
Arnold AG, Otegbeye E, Fleischut MH, et al. Assessment of individuals with BRCA1
and BRCA2 large rearrangements in high-risk breast and ovarian cancer families.
Breast Cancer Res Treat. 2014 Jun;145(3):625-634.
9.
Daniels MS, Babb SA, King RH, et al. Underestimation of risk of a BRCA1 or BRCA2
mutation in women with high-grade serous ovarian cancer by BRCAPRO: a multiinstitution study. J Clin Oncol. 2014 Apr 20;32(12):1249-1255.
(continued)
10. Engert S, Wappenschmidt B, Betz B, et al. MLPA screening in the BRCA1 gene from
1,506 German hereditary breast cancer cases: Novel deletions, frequent involvement of
exon 17, and occurrence in single early-onset cases. Hum Mutat. 2008 Jul;29(7):948958.
11. Finch A, Bacopulos S, Rosen B, et al. Preventing ovarian cancer through genetic
testing: a population-based study. Clin Genet. 2014 Nov;86(5):496-499.
12. Gabai-Kapara E, Lahad A, Kaufman B, et al. Population-based screening for breast and
ovarian cancer risk due to BRCA1 and BRCA2. Proc Natl Acad Sci U S A. 2014 Sep
30;111(39):14205-14210.
13. 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;346(21):1609-1615.
14. Manchanda R, Legood R, Burnell M, et al. Cost-effectiveness of population screening
for BRCA mutations in Ashkenazi jewish women compared with family history-based
testing. J Natl Cancer Inst. 2014 Nov 30;107(1):380.
15. Manguoglu E, Guran S, Yamac D, et al. Genomic large rearrangement screening of
BRCA1 and BRCA2 genes in high-risk Turkish breast/ovarian cancer patients by using
multiplex ligation-dependent probe amplification assay. Cancer Invest. 2011
Jan;29(1):73-77.
16. Moyer VA, LeFevre ML, Siu AL, et al. 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 Feb 18;160(4):271-281.
17. Palma MD, Domchek SM, Stopfer J, et al. The relative contribution of point mutations
and genomic rearrangements in BRCA1 and BRCA2 in high-risk breast cancer families.
Cancer Res. 2008 Sep;68(17):7006-7014.
18. Preisler-Adams S, Schonbuchner I, Fiebig B, et al. Gross rearrangements in BRCA1
but not BRCA2 play a notable role in predisposition to breast and ovarian cancer in
high-risk families of German origin. Cancer Genet Cytogenet. 2006 Jul;168(1):44-49.
19. Rebbeck TR, Lynch HT, Neuhausen SL, et al. Prophylactic oophorectomy in carriers of
BRAC1 or BRCA2 mutations. N Engl J Med. 2002;346(21):1616-1622.
To view ConnectiCare’s list of policies on various medical treatments and emerging
technologies, go to
www.connecticare.com/provider/MedicalPolicyCriteria.aspx
^Back to Top
Medical Pre-Authorization Criteria
Genetic Testing, BRCA 1 & 2 (BRAC Analysis)
Page 3 of 4
MEDICAL PRE-AUTHORIZATION CRITERIA
REFERENCES
(continued)
20. Sharma P, Klemp JR, Kimler BF, et al. Germline BRCA mutation evaluation in a
prospective triple-negative breast cancer registry: implications for hereditary breast
and/or ovarian cancer syndrome testing. Breast Cancer Res Treat. 2014
Jun;145(3):707-714.
21. Sluiter MD, van Rensburg EJ. Large genomic rearrangements of the BRCA1 and
BRCA2 genes: Review of the literature and report of a novel BRCA1 mutation. Breast
Cancer Res Treat. 2011 Jan;125(2):325-349.
22. Stadler ZK, Sloustros E, Hansen SA, et al. Absence of genomic BRCA1 and BRCA2
rearrangements in Ashkenazi breast and ovarian cancer families. Breast Cancer Res
Treat. 2010 Sep;123(2):581-585.
23. Woodward AM, Davis TA, Silva AG, et al. Large genomic rearrangements of both
BRCA2 and BRCA1 are a feature of the inherited breast/ovarian cancer phenotype in
selected families. J Med Genet. 2005 May;42(5):e31
REVIEW
HISTORY
11/13/02, 03/12/03, 03/10/04, 04/13/05, 10/11/06, 11/07/07, 10/29/08, 10/14/09, 11/10/10,
11/09/11, 12/05/12, 05/01/13, 09/03/13, 05/07/14, 05/06/15, 07/06/16
To view ConnectiCare’s list of policies on various medical treatments and emerging
technologies, go to
www.connecticare.com/provider/MedicalPolicyCriteria.aspx
^Back to Top
Medical Pre-Authorization Criteria
Genetic Testing, BRCA 1 & 2 (BRAC Analysis)
Page 4 of 4