Coverage Policies

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)    BRCA testing requires pre-authorization.

2)    For women without personal history of breast cancer (Preventive):

The U.S. Preventive Services Task Force (USPSTF) recommends referral for genetic counseling and evaluation for BRCA testing in those women with a family history associated with an increased risk of deleterious mutations in BRCA1 or BRCA2 genes (Grade B recommendation). These recommendations apply to women who have not received a diagnosis of breast, ovarian, tubal, or peritoneal cancer.

3)    BRCA testing for women with personal history of breast, ovarian, tubal, or peritoneal cancer (Medical).

4)    QualChoice follows NCCN Guidelines and DNA Direct for genetic testing. However, when NCCN guidelines or DNA Direct indicate that more than one test may be appropriate for the same clinical scenario, only the most cost effective test(s) will be covered. 

5)    With NCCN and DNA Direct now recommending the use of genetic panel screening for women who qualify for BRCA screening, QualChoice will follow this recommendation—only for specific genetic panels that have been shown to be cost effective.  The reason for the change in position by NCCN and DNA Direct is that BRCA mutations account for only about 50% of the cancers in this high risk group.  The Myriad myRisk screening panel (which includes additional clinically relevant mutations for patients at high risk for breast/ovarian/peritoneal cancer or Lynch Syndrome) will be covered in this situation.  However, the panel will not be covered if there is a known family BRCA mutation—in that situation more limited/focused screening is indicated.

6)    In order to avoid inaccurate, incomplete or untimely requests, all prior-authorization requests for Blood genetic tests require the following:

a) The request is submitted by the ordering provider office AND

b) Submitted clinical is from patient medical records such as provider clinic progress notes. Information on lab request forms is not accepted, AND

c) The request is submitted before or at the most within 14 days after the collection of the blood specimen for the test.

Preventive Care

QualChoice considers molecular susceptibility screening for breast and/or epithelial ovarian cancer (“BRCA testing” or myRisk panel testing) medically necessary once per lifetime in any of the following categories:

1)    Adults at high-risk of breast or epithelial ovarian cancer (adapted from the U.S. Preventive Services Task Force guidelines (for screening indications).

2)    Women without a personal history of breast cancer, epithelial ovarian cancer, or pancreatic adenocarcinoma, and any of the following:

a)    Women with 3 or more close blood relatives on the same side of the family with breast cancer, irrespective of age at diagnosis; OR

b)    Women with 1 or more close blood relatives on the same side of the family with breast cancer and 1 or more close blood relatives on the same side of the family with epithelial ovarian cancer; OR

c)    Women with 2 or more close blood relatives on the same side of the family with epithelial ovarian cancer; OR

d)    Women with 1 or more male close blood relatives with breast cancer; OR

e)    Women with 2 or more close blood relatives on the same side of the family with breast cancer, 1 of whom was diagnosed at age 50 years and younger; OR

f)     Women with 1 or more 1st degree relatives with bilateral breast cancer; OR

g)    Women with 1 or more close blood relatives with both breast and epithelial ovarian cancer; OR

h)    Women of Ashkenazi Jewish descent with 1 or more 1st-degree relatives or two or more 2nd-degree relatives on the same side of the family with breast or epithelial ovarian cancer.

NCCN and DNA Direct are now recommending the use of genetic panel testing for any of the above scenarios of women who qualify for BRCA screening, QualChoice will follow this recommendation—only for specific genetic panels that have been shown to be cost effective.  The reason for the change in position by NCCN and DNA Direct is that BRCA mutations account for only about 50% of the cancers in this high risk group. The Myriad myRisk screening panel (which includes additional clinically relevant mutations for patients at high risk for breast/ovarian/peritoneal cancer or Lynch Syndrome) will be covered in this situation. 

However, the panel will not be covered if there is a known family BRCA mutation—in that situation more limited/focused screening is indicated.  QualChoice considers molecular susceptibility testing for breast and/or epithelial ovarian cancer (“Targeted/focused BRCA screening”) medically necessary once per lifetime for women/men with 1 or more 1st, 2nd, or 3rd degree blood relatives with a known BRCA1 or BRCA2 mutation.

Medical Benefits

Based on the American College of Obstetricians and Gynecologists and the American College of Medical Genetics (for testing persons with cancer),

1)    For women with any of the following:

a)    Personal history of epithelial ovarian cancer; OR

b)    Personal history of breast cancer and any of the following:

i.  Breast cancer is diagnosed at age 45 years or younger, with or without family history; OR

ii.  Breast cancer is diagnosed at age 50 years or younger, with any of the following:

a.  At least 1 close blood relative with breast cancer at age 50 years or younger; OR

b.  At least 1 close blood relative with epithelial ovarian cancer; OR

c.  Bilateral breast cancer or 2 primary breast cancers with 1st primary diagnosed at age 50 years or younger; OR

d.  Limited family structure or no family history available because member is adopted.

iii.   Breast cancer is diagnosed at age 60 years or younger, and is triple receptor negative.

iv.   Breast cancer is diagnosed at any age, with any of the following:

                                          a.  At least 2 close blood relatives on the same side of the family with breast cancer and/or epithelial ovarian cancer at any age; OR

                                          b.  The member has 2 breast primaries and also has at least 1 close blood relative with breast cancer diagnosed at age 50 years or younger; OR

                                          c.  The member has 2 breast primaries and also has at least 1 close blood relative with epithelial ovarian cancer; OR

                                          d.  At least 1 close male blood relative with breast cancer; OR

                                          e.  At least 1 1st, 2nd, or 3rd degree blood relative with a known BRCA1 or BRCA2 mutation; OR

                                           f.  2 close relatives on the same side of the family with pancreatic adenocarcinoma at any age; OR

                                          g.  If ethnicity is associated with higher mutation frequency (Ashkenazi Jewish), no additional family history is required.

                                          h.  Women with a personal history of pancreatic adenocarcinoma at any age with 2 close relatives on the side same side of the family with breast cancer, epithelial ovarian cancer, and/or pancreatic adenocarcinoma at any age.

v.    Women who do not meet any of the above criteria but are determined through both independent formal genetic counseling and validated quantitative risk assessment tool to have at least a 10% pre-test probability of carrying a BRCA1 or BRCA2 mutation. Note: In this category only, a 3-generation pedigree and quantitative risk assessment results must be provided to QualChoice.

2)    For men with any of the following:

a)    Personal history of breast cancer.

3)    The following BRCA tests are covered only once per lifetime with prior-authorization:

·      BRCA1, BRCA2 gene analysis; full sequence analysis and full duplication/deletion analysis

·      BRCA1, BRCA2 gene analysis; full sequence analysis and common duplication/deletion variants in BRCA1

·         BRCA1, BRCA2 gene analysis; 185delAG, 5385insC, 6174delT variants

·         BRCA1 gene analysis; full sequence analysis and common duplication/deletion variants

·         BRCA1 gene analysis; known familial variant

·         BRCA2 gene analysis; full sequence analysis

·         BRCA2 gene analysis; known familial variant

·         Germline BRCA1, BRCA2 testing – BRACAnalysis CDx is an FDA approved companion test for Olaparib (Lynparza). Olaparib therapy has been shown to improve outcomes with the corresponding germline BRCA mutation. It requires prior- authorization and is considered medically necessary for:

1)    Members with HER2-negative recurrent metastatic breast cancer eligible for single agent therapy with Olaparib; OR

2)    Members with advanced ovarian cancer who have received 3 or more lines of chemotherapy and are being considered for treatment with Olaparib; AND

3)    Member has not previously had full gene sequencing of BRCA1 and BRCA2; AND

4)    Member does not have a known BRCA mutation in the family.

4)    The following BRCA tests are not covered:

·         BRCA1, BRCA2 gene analysis; uncommon duplication/deletion variants.

·         BRCA1, BRCA2 somatic mutation analysis & analysis of homologous recombination deficiency pathways

QualChoice considers BRCA testing experimental and investigational for all other indications including testing in men for surveillance, as well as assessment of risk of other cancers such as prostate cancer, and colon cancer because its effectiveness for these indications has not been established.

Codes Used In This BI:         

§  BRCA testing is not considered medically necessary for individuals less than 18 years of age.

§  QualChoice does not cover BRCA testing of members, if testing is performed primarily for the medical management of other family members.

§  Generally, in cases where BRCA testing is indicated due to family history of breast cancer and a specific BRCA mutation has been detected in the family member affected by breast cancer (the index case), then a mutation-specific assay for that single mutation, rather than full gene sequencing, is considered medically necessary for testing unaffected family members at high risk for breast cancer. However, full gene sequencing may be considered medically necessary if the member requesting approval for BRCA testing is the child of an individual with a known BRCA mutation, and the member would also qualify for BRCA testing solely due to risks from the other parent`s family and the other parent has not been tested for a BRCA mutation.

§  BRCA testing of men with breast cancer is considered medically necessary to assess the man`s risk of recurrent breast cancer and/or to assess the breast cancer risk of a female member where the affected male is a 1st- or 2nd-degree blood relative of that member. BRCA testing to assess the risk of breast or prostate cancer in men without breast cancer or for surveillance is considered experimental and investigational.

Large Genomic Re-Arrangements

There is inadequate information regarding the frequency of large genomic re-arrangements (BART testing) in the United States populations to indicate that use of this technique or re-testing for these specific mutations is established and medically necessary for members with a personal or family history of breast, epithelial ovarian cancer, or pancreatic cancer (e.g., the BRCAnalysis® Rearrangement Test or BRCAvantage™ Rearrangements). Thus, QualChoice considers the use of BART or re-testing previously tested high-risk members for large genomic re-arrangements experimental and investigational.

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.