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Date Printed: June 26, 2017: 01:11 AM

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05-82000-30

Original Effective Date: 10/15/01

Reviewed: 01/26/17

Revised: 02/15/17

Subject: Genetic Testing for Hereditary Breast or Ovarian Cancer

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
           
Other References Updates    
           

DESCRIPTION:

Several genetic syndromes with an autosomal dominant pattern of inheritance that feature breast cancer have been identified. Of these, hereditary breast and ovarian cancer (HBOC) and some cases of hereditary site-specific breast cancer have in common causative mutations in BRCA genes. Families suspected of having HBOC syndrome are characterized by an increased susceptibility to breast cancer occurring at a young age, bilateral breast cancer, male breast cancer, and ovarian cancer at any age. Other cancers, such as prostate cancer, pancreatic cancer, gastrointestinal cancers, melanoma, laryngeal cancer, occur more frequently in HBOC families. Hereditary site-specific breast cancer families are characterized by early onset breast cancer with or without male cases, but without ovarian cancer.

Germline mutations in the BRCA1 and BRCA2 genes are responsible for the cancer susceptibility in the majority of HBOC families, especially if ovarian cancer or male breast cancer are features. However, in site-specific breast cancer, BRCA mutations are responsible for only a proportion of affected families, and research to date has not yet identified other moderate or high-penetrance gene mutations that account for disease in these families. BRCA gene mutations are inherited in an autosomal dominant fashion through either the maternal or paternal lineage. It is possible to test for abnormalities in BRCA1 and BRCA2 genes to identify the specific mutation in cancer cases, and to identify family members with increased cancer risk.

POSITION STATEMENT:

 

Certificate of Medical Necessity

Submit a completed Certificate of Medical Necessity (CMN) along with your request for Genetic Testing for Hereditary Breast or Ovarian Cancer to expedite the medical review process.

Click the link Genetic Testing for Hereditary Breast or Ovarian Cancer - Certificate of Medical Necessity (MS Word) to open the form.

Complete all fields on the form thoroughly.

Print and submit a copy of the form with your request.

Note: Florida Blue regularly updates CMNs. Ensure you are using the most current copy of a CMN before submitting to Florida Blue. For a complete list of available CMNs, visit the Certificates of Medical Necessity page.

NOTE: Coverage for genetic testing, screening, and counseling are applicable only under those contracts that include benefits for genetic testing, preventive health services, screening services, and medical counseling.

BRCA1 and BRCA2 gene sequencing meets the definition of medical necessity for women or men who meet ONE of the following criteria:

1. Member with a close blood relative* with a known deleterious BRCA1/BRCA2 gene mutation.

2. Member with a personal history of breast cancer and ONE of the following:

• Diagnosed age ≤45 years;

• Diagnosed age ≤50 years with an additional breast cancer primary (bilateral tumor or two or more clearly separate ipsilateral tumors occurring either synchronously or asynchronously);

• Diagnosed age ≤50 years with ≥1 close blood relative* with pancreatic cancer, prostate cancer (Gleason score≥7), or breast cancer at any age (or with a limited or unknown family history);

• Diagnosed age ≤ 60 years with a triple negative (estrogen receptor-negative, progesterone receptor-negative, human epidermal growth factor receptor 2-negative) breast cancer;

• Diagnosed at any age with ≥1 close blood relative* with breast cancer diagnosed ≤50 years;

• Diagnosed at any age with ≥2 close blood relatives* with pancreatic cancer, prostate cancer (Gleason score≥7), or breast cancer at any age;

• Diagnosed at any age with ≥1 close blood relative* with ovarian cancer(including fallopian tube and primary peritoneal cancers); Diagnosed at any age with a close male blood relative* with breast cancer;

• Diagnosed at any age and with an ethnicity associated with higher mutation frequency (e.g., Ashkenazi Jewish descent).

3. Member with a personal history of ovarian cancer (including fallopian tube and primary peritoneal cancers) diagnosed at any age.

4. Member with a personal history of male breast cancer diagnosed at any age.

5. Member with a personal history of pancreatic cancer or prostate cancer (Gleason score ≥7) diagnosed at any age and with ≥1 close blood relative* with ovarian cancer (including fallopian tube and primary peritoneal cancers) at any age or breast cancer (≤50 years); OR with ≥2 close relatives with breast cancer, pancreatic cancer, or prostate cancer (Gleason score ≥7) at any age.

6. Member with a personal history of pancreatic cancer and Ashkenazi Jewish ancestry.

7. Member WITHOUT a personal history of breast or ovarian cancer who has a first- or second-degree blood relative* meeting criteria 2, 3, 4, 5, or 6.

8. Member WITHOUT a personal history of breast or ovarian cancer who has a third-degree blood relative* with breast cancer or ovarian cancer (including fallopian tube and primary peritoneal cancers) AND ≥2 close blood relatives* with breast cancer (at least one with breast cancer at age 50 years or younger) or ovarian cancer (including fallopian tube and primary peritoneal cancers).

*Close blood relatives include first-, second-, and third-degree relatives on the same side of the family. First-degree relatives: children, brothers, sisters and parents. Second-degree relatives: grandparents, aunts, uncles, nieces, nephews, half-siblings, and grandchildren. Third-degree relatives: great-grandparents, great-aunts, great-uncles, great-grandchildren, and first cousins.

BRCA testing is considered experimental or investigational for all other indications including screening of breast cancer, ovarian cancer, cancer of fallopian tube, or primary peritoneal cancer or for risk assessment of other cancers. There is a lack of clinical data to permit conclusions on the clinical management of the patient and net health outcomes.

BRACAnalysis® Rearrangement Test (BART™) meets the definition of medical necessity for individuals that meet the BRCA testing criteria listed above.

BRACAnalysis Rearrangement Test (BART) is considered experimental or investigational for all other indications including screening in the general population. There is a lack of clinical data to permit conclusions on the clinical management of the patient and net health outcomes.

Genetic testing in minors for BRCA1 or BRCA mutations is considered experimental or investigational. There is no change in management for minors as a result of knowledge of the presence or absence of a deleterious mutation. In addition, there are potential harms related to stigmatization and discrimination.

Testing for BARD1 mutations is considered experimental or investigational for all indications. The evidence is insufficient to determine the effects of this testing on health outcomes.

BILLING/CODING INFORMATION:

CPT Coding:

81162

BRCA1, BRCA2 (breast cancer 1 and 2) (eg, hereditary breast and ovarian cancer) gene analysis; full sequence analysis and full duplication/deletion analysis

81211

BRCA 1, BRCA2 (breast cancer 1 and 2) (e.g. hereditary breast and ovarian cancer) gene analysis: full sequence analysis and common duplication/deletion variants in BRCA1 (ie, exon 13 del 3.835kb, exon 13 dup 6kb, exon 14-20 del 26kb, exon 22 del 510bp, exon 8-9 del 7.1kb)

81212

BRCA1, BRCA2 (breast cancer 1 and 2) (e.g. hereditary breast and ovarian cancer) gene analysis; 185delAG, 5385insC, 6174delT variants)

81213

BRCA1, BRCA2 (breast cancer 1 and 2) (e.g. hereditary breast and ovarian cancer) gene analysis; uncommon duplication/deletion variants

81214

BRCA1 (breast cancer 1) (e.g. hereditary breast and ovarian cancer) gene analysis; full sequence analysis and common duplication/deletion variants (ie, exon 13 del 3.835kb, exon 13 dup 6kb, exon 14-20 del 26kb, exon 22 del 510bp, exon 8-9 del 7.1kb)

81215

BRCA1 (breast cancer 1) (e.g. hereditary breast and ovarian cancer) gene analysis; known familial variant)

81216

BRCA2 (breast cancer 2) (e.g. hereditary breast and ovarian cancer) gene analysis; full sequence analysis)

81217

BRCA2 (breast cancer 2) (e.g. hereditary breast and ovarian cancer) gene analysis; known familial variant)

Genetic Counseling: Genetic counseling is covered in accordance to the member’s contract benefits for medical counseling. Pre and post genetic counseling may be considered medically necessary as an adjunct to the genetic tests. The following codes may be reported:

CPT Coding:

96040

Medical genetics and genetic counseling services, each 30 minutes face-to-face with patient/family

HCPCS Coding:

S0265

Genetic counseling, under physician supervision, each 15 minutes

REIMBURSEMENT INFORMATION:

None applicable

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products:

The following guideline was reviewed on the last guideline reviewed date: Palmetto GBA MOLDX: Approved Gene Testing (M00041, V16) located at palmettogba.com.

DEFINITIONS:

Triple-negative breast cancer: describes breast cancer cells that do not have estrogen receptors, progesterone receptors, or large amounts of HER2/neu protein. Also called ER-negative PR-negative HER2/neu-negative and ER-PR-HER2/neu-.

RELATED GUIDELINES:

Genetic Testing, 05-82000-28
Genetic Testing for Lynch Syndrome and Other Inherited Colon Cancer Syndromes, 05-82000-31

Magnetic Resonance Imaging of the Breast, 04-70540-09

Preventive Services, 01-99385-03

Prophylactic Mastectomy, 02-12000-15

OTHER:

None applicable

REFERENCES:

  1. American College of Obstetricians and Gynecologists (ACOG), Clinical Management Guidelines for Obstetrician-Gynecologists: Hereditary Breast and Ovarian Cancer Syndrome, Number 103, April 2009.
  2. American College of Obstetricians and Gynecologists (ACOG), Routine Screening for Hereditary Breast and Ovarian Cancer Recommended, 03/09, accessed at acog.org on 08/14/09.
  3. The American Society of Breast Surgeons, Position Statement on BRCA Genetic Testing for Patients With and Without Breast Cancer, 09/2012, accessed at breastsurgeons.org 05/21/15.
  4. American Society of Clinical Oncology (ASCO) Policy Statement Update: Genetic Testing for Cancer Susceptibility, 2010, accessed at asco.org 05/21/15.
  5. Begg CB, Haile RW, Borg A, et al, Variation of Breast Cancer Risk Among BRCA ½ Carriers, JAMA, January 9/16, 2008 – Vol 299, No. 2.
  6. Berliner JL, Fay AM, et al, Risk Assessment and Genetic Counseling for Hereditary Breast and Ovarian Cancer: Recommendations of the National Society of Genetic Counselors, accessed at guideline.gov on 08/14/09.
  7. Blue Cross Blue Shield Association Medical Policy Reference Manual 2.04.02 Genetic Testing for Hereditary Breast/Ovarian Cancer Syndrome (BRCA1 or BRCA2), 11/16.
  8. Blue Cross Blue Shield Association Technology Evaluation Center (TEC) “Genetic Testing for Inherited BRCA1 or BRCA2 Mutations” (06/97).
  9. Clinicaltrials.gov, Clinical Outcomes in Hereditary Cancer, sponsored by Memorial Sloan-Kettering Cancer Center, accessed 08/14/09.
  10. Clinicaltrials.gov, Clinical Significance of Germline BRCA Mutations, sponsored by Memorial Sloan-Kettering Cancer Center, accessed 08/14/09.
  11. Clinicaltrials.gov, Germline BRCA1 or BRCA2 Mutations in Jewish Women Affected by Breast Cancer, sponsored by Memorial Sloan-Kettering Cancer Center, Sarah Lawrence College, University of Washington, accessed 08/14/09.
  12. Clinicaltrials.gov, Impact of Testing Positive for the BRCA1 or BRCA2 Mutation in Young Women Who are BRCA1 or BRCA2 Mutation Carriers, sponsored by National Cancer Institute, accessed 08/14/09.
  13. ClinicalTrials.gov, Standard Genetic Counseling With or Without a Decision Guide in Improving Communication Between Mothers Undergoing BRCA1/2 Testing and Their Minor-Age Children, sponsored by Lombardi Cancer Research Center, accessed 06/10/10.
  14. Clinicaltrials.gov, Study of Individuals and Families at High Risk for Breast or Ovarian Cancer, sponsored by National Cancer Institute, accessed 06/10/10.
  15. Clinicaltrials.gov, Studying Breast Cancer Risk in Women who are BRCA1/BRCA2 Mutation Carriers, sponsored by Gynecologic Oncology Group, National Cancer Institute, accessed 06/10/10.
  16. ECRI Institute, Health Technology Forecast Study: BRCA Testing Significantly Affects Treatment Decisions, 04/09/04.
  17. ECRI Institute Product Brief, BRACAnalysis Test (Myriad Genetics, Inc.) for Assessing Hereditary Breast and Ovarian Cancer Risk, May 2013.
  18. ECRI Target Report #274 “Genetic testing for BRCA1 and BRCA2 mutations for assessing breast cancer risk” (08/98) – 02/01 update.
  19. ECRI Target Report #275 “Genetic testing for BRCA1 and BRCA2 mutations for assessing ovarian cancer risk” (08/98) 02/01 update.
  20. Genzyme Genetics Document for Request for Allowable & Maximum Units for CPT Code, 2002.
  21. Hayes Medical Technology Directory “Genetic Testing for Susceptibility To Breast Cancer” 12/02 (01/07 update).
  22. Hayes Medical Technology Directory “Genetic Testing for Susceptibility To Ovarian Cancer” (02/05)
  23. Hirst JE, Gard GB, McIllroy K, et al, High Rates of Occult Fallopian Tube Cancer Diagnosed at Prophylactic Bilateral Salpingo-Oophorectomy, Int J Gynecol Cancer 2009; 19(5): 826-9.
  24. Irminger-Finger, Ratajska M, Pilyugin M, New Concepts on BARD1: Regulator of BRCA Pathways and Beyond. Int J Biochem Cell Biol. 2016 Mar;72:1-17.
  25. Judkins T, et al. Clinical significance of large rearrangements in BRCA1 and BRCA2. Cancer. doi: 10.1002/cncr.27556, 2012.
  26. Myriad Genetics, Inc. accessed at myriad.com on 07/02/12.
  27. National Cancer Institute (NCI), NCI Fact Sheet- BRCA1 and BRCA2: Cancer Risk and Genetic Testing, last reviewed: 01/22/14. Accessed at cancer.gov 09/09/14.
  28. National Comprehensive Cancer Network, (NCCN) Clinical Practice Guidelines in Oncology, Genetic/Familial High-Risk Assessment: Breast and Ovarian, V. 2.2017.
  29. National Guideline Clearinghouse (NGC). Guideline Summary NGC-7204: Hereditary Breast and Ovarian Cancer Syndrome. American College of Obstetricians, accessed at guideline.gov 09/18/13.
  30. National Institute of Health The Task Force on Genetic Testing, September 1997.
  31. O’Neill SC, Peshkin BN, Luta G, et al, Primary Care Providers’ Willingness to Recommend BRCA1/2 Testing to Adolescents, Familial Cancer (2010), 9:43-50.
  32. Palmetto GBA, MOLDX: Approved Gene Testing (M00041, V16), accessed at palmettogba.com.
  33. U.S. Preventive Services Task Force (USPSTF). Recommendation Statement: Risk Assessment, Genetic Counseling, and Genetic Testing for BRCA-Related Cancer in Women. Release date: December 2013. Accessed at uspreventiveservicestaskforce.gov 01/05/17.
  34. Wenstrup R, Judkins T, et al, Journal of Clinical Oncology, 2007 ASCO Annual Meeting Proceedings Part I. Vol 25, No. 18S, 2007: 10513.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 01/26/17.

GUIDELINE UPDATE INFORMATION:

11/15/03

Annual review. Developed separate policy for Genetic Testing for Inherited BRCA1 and BRCA2 Mutations. Added coverage and non-coverage statement for BRCA testing of men.

07/01/05

HCPCS update. Added S0265.

12/15/05

Biennial review. Coverage statement changed to reflect BCA policy. Non-coverage section reworded. Information added to Description section.

01/01/06

Annual HCPCS coding update: added 83900, 83907, 83908, 83909, and 83914; revised 83898 & 83901.

06/15/06

Revision to include new codes into limitation section.

10/15/06

Revision to coverage statement; definitions added.

01/01/07

Annual HCPCS coding update: added 96040, deleted 99401, 99402, 99403, 99404.

07/15/07

Annual review, coverage statements maintained, guideline reformatted, references updated.

01/01/08

Annual HCPCS coding update: revised 83898, 83900, 83901, and 83908.

01/01/09

Annual HCPCS coding update: descriptor revised for codes 83890, 83891, 83892, 83893, 83894, 83897, 83900, 83903, 83907, 83909, and 83914.

09/15/09

Annual review: position statements updated, description section, guideline title, and references updated.

10/15/09

Reimbursement Information section updated.

08/15/10

Annual review: position statements updated to include “cancer of fallopian tube or primary peritoneal cancer” to be considered along with breast and ovarian cancer in assessing family history; additional position statements added regarding CHEK2 testing and testing for minors; description section and references updated.

04/01/11

Revision; Certificate of Medical Necessity added.

08/15/11

Scheduled review; position statements and references updated; formatting changes.

01/01/12

Annual HCPCS update. Added CPT codes 81211-81217; revised Billing/Coding and Reimbursement Information sections.

04/01/12

Quarterly HCPCS update. Deleted codes S3818-S3823.

08/15/12

Annual review; position statements, description section, and references updated.

11/15/13

Annual review; position statements, program exception, and references updated.

11/15/14

Annual review; position statements and references updated.

07/15/15

Annual Review; position statements, program exception, and references updated.

01/01/16

Annual HCPCS/CPT update; code 81162 added.

08/15/16

Revision; position statement section and references updated.

02/15/17

Revision; position statements and references updated.

Date Printed: June 26, 2017: 01:11 AM