Genetic Testing for Breast, Ovarian and Pancreatic Cancer Susceptibility Form

Description

Genetic testing is a laboratory method that is performed to analyze an individual’s deoxyribonucleic acid (DNA) to detect gene variants (mutations) associated with inherited conditions including hereditary cancer such as breast, ovarian (including fallopian tube and peritoneal) and pancreatic cancer. Testing may be appropriate for an affected individual as well as asymptomatic relatives at increased risk for cancer. This type of testing may also be referred to as germline genetic testing.

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Genetic Testing for Breast, Ovarian and Pancreatic Cancer Susceptibility

Effective Date: 03/23/2023
Revision Date: 03/23/2023
Review Date: 03/23/2023
Policy Number: HUM-0536-023
Page: 2 of 42

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Additional inherited cancers include Li-Fraumeni syndrome (LFS) and PTEN hamartoma tumor syndrome/Cowden syndrome. Both are rare, inherited conditions that are associated with increased risk of many types of cancer.

Familial risk stratification tools (7-Question Family History Screening Tool, BRCAPRO, International Breast Cancer Intervention Study Instrument [Tyrer-Cuzick], Manchester Scoring System, Ontario Family History Assessment Tool, Pedigree Assessment Tool, Referral Screening Tool) may be used at a physician’s office to aid in the determination of an individual’s risk for hereditary breast ovarian cancer (HBOC) and potential for harboring harmful BRCA gene mutations.

Multigene (or expanded) panels analyze a broad set of genes simultaneously (as opposed to single gene testing that searches for variants in one specific gene) and have been proposed to evaluate the DNA of an individual with a personal and/or family history of more than 1 hereditary condition or syndrome. Panels often include medically actionable genes but may also include those with unclear medical management. Targeted (or focused) multigene panels analyze a limited number of genes targeted to a specific condition.

For information regarding array comparative genomic hybridization (aCGH) to detect deletions/duplications and/or for full gene sequence analysis for single gene disorders, please refer to Comparative Genomic Hybridization/Chromosomal Microarray Analysis Medical Coverage Policy.

For information regarding direct-to-consumer testing, such as Personal Genome Service Genetic Health Risk (GHR) Report for BRCA1/BRCA2 (Selected Variants), please refer to Code Compendium (Laboratory) Medical Coverage Policy.

For information regarding MyRisk, please refer to Genetic Testing for Cancer Susceptibility Medical Coverage Policy.

For information regarding genetic testing for the following, please refer to Genetic Testing Medical Coverage Policy:

• DNA banking or preservation
• General population screening
• Individual 17 years of age or younger for adult-onset conditions

Genetic Testing for Breast, Ovarian and Pancreatic Cancer Susceptibility

Effective Date: 03/23/2023
Revision Date: 03/23/2023
Review Date: 03/23/2023
Policy Number: HUM-0536-023
Page: 3 of 42

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• Interpretation and reporting for molecular pathology procedure
• Polygenic risk score (PRS) and single nucleotide polymorphisms (SNPs)
• Repeat germline or somatic genetic testing
• Retrieved archival tissue

Humana recognizes that the field of genetic testing is rapidly changing and that other tests may become available.

Coverage Determination

Any state mandates for genetic testing for breast, ovarian or pancreatic cancer susceptibility take precedence over this medical coverage policy.

Genetic testing may be excluded by certificate. Please consult the member’s individual certificate regarding Plan coverage.

Apply General Criteria for Genetic and Pharmacogenomics Tests when disease- or gene-specific criteria are not available on a medical coverage policy. For information regarding general criteria for genetic tests, please refer to Genetic Testing Medical Coverage Policy.

HEREDITARY BREAST CANCER – CORE GENES BRCA1, BRCA2, CDH1, PALB2, PTEN, TP53

Hereditary Breast Cancer – Affected Individual

Humana members may be eligible under the Plan for sequencing and/or deletion/ duplication analysis (also known as large genomic rearrangement analysis [performed concurrently or sequentially]) for hereditary breast cancer when the following criteria are met:

• Pre- and post-test genetic counseling; AND
• Single gene testing of BRCA1, BRCA2, CDH1, PALB2, PTEN or TP53 genes; OR
• Genomic sequencing and/or deletion/duplication analysis targeted panel that includes 2 or more core genes BRCA1, BRCA2, CDH1, PALB2, PTEN and/or TP53; AND
• Personal history of breast cancer (includes invasive ductal carcinoma in situ [DCIS]); AND
  • Diagnosed at 50 years of age or younger; OR
  • Diagnosed at any age; AND
    • Ashkenazi Jewish ancestry*; OR
    • Lobular breast cancer with a personal or family history (first-, second- or third-degree relative) of diffuse gastric cancer; OR
    • Multiple primary breast cancers (synchronous [occurring simultaneously] or metachronous [occurring at different time periods]); OR
    • Personal history of male** breast cancer; OR
    • Triple-negative breast cancer; OR
    • At least 1 first-, second- or third-degree relative diagnosed with any of the following:
      • Breast cancer at 50 years of age or younger; OR
      • Male** breast cancer; OR
      • Ovarian cancer; OR
      • Pancreatic cancer; OR
      • Prostate cancer with any of the following features:
        • Metastatic (includes distant metastasis and regional bed or nodes) established by biopsy and/or radiography; OR
        • High-risk features with no very-high risk features and exactly one of the following:

Genetic Testing for Breast, Ovarian and Pancreatic Cancer Susceptibility

Effective Date: 03/23/2023
Revision Date: 03/23/2023
Review Date: 03/23/2023
Policy Number: HUM-0536-023
Page: 4 of 42

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Genetic Testing for Breast, Ovarian and Pancreatic Cancer Susceptibility

Effective Date: 03/23/2023
Revision Date: 03/23/2023
Review Date: 03/23/2023
Policy Number: HUM-0536-023
Page: 5 of 42

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• T3a; OR Grade Group 4 or Grade Group 5; OR Prostate-specific antigen (PSA) greater than 20 ng/mL; OR
• Very-high-risk features characterized 1 or more of the following:
  • T3b – T4; OR
  • Gleason pattern 5; OR
  • 2 or more high-risk features; OR
  • More than 4 cores with Grade Group 4 or Grade Group 5; OR
• 3 or more total diagnoses of breast cancer in the individual and/or in first-, second- or third-degree relatives (on the same side of the family); OR
• 2 or more first-, second- or third-degree relatives diagnosed with either breast cancer or prostate cancer (any grade) at any age; OR
• Mutation identified on tumor genomic testing that has clinical implications if also identified in the germline; OR
• Does not meet above criteria and a USPSTF recognized risk stratification tool indicates greater than 5% probability for a BRCA1/2 pathogenic variant

Hereditary Breast Cancer – Unaffected Individual

Refer to Hereditary Breast Cancer – Known Familial Pathogenic or Likely Pathogenic Variant section and Coverage Limitations section regarding known familial variant (KFV) testing.

Humana members may be eligible under the Plan for sequencing and/or deletion/duplication analysis (also known as large genomic rearrangement analysis [performed concurrently or sequentially]) for hereditary breast cancer when the following criteria are met:

• Pre- and post-test genetic counseling; AND
• Individual to be tested is unaffected; AND
• An affected first-, second- or third-degree relative is unavailable for genetic testing (eg, deceased, declines genetic testing or unable to contact); AND
  • Single gene testing of BRCA1, BRCA2, CDH1, PALB2, PTEN or TP53 genes; OR
  • Genomic sequencing and/or deletion/duplication analysis targeted panel that includes 2 or more core genes BRCA1, BRCA2, CDH1, PALB2, PTEN and/or TP53; AND
• Ashkenazi Jewish ancestry* when the individual to be tested has a first- degree relative diagnosed at any age with epithelial ovarian, fallopian tube, peritoneal, pancreatic or prostate cancer; OR
• Has an affected first-degree relative diagnosed at any age with pancreatic cancer; OR
• Has an affected first-degree relative diagnosed with prostate cancer at any age with any of the following features:
  • Metastatic (includes distant metastasis and regional bed or nodes) established by biopsy and/or radiography; OR
  • High-risk features with no very-high risk features and exactly 1 of the following:
    • T3a; OR
    • Grade Group 4 or Grade Group 5; OR
    • PSA greater than 20 ng/mL; OR
• Very-high-risk features characterized 1 or more of the following:
  • T3b – T4; OR
  • Gleason pattern 5; OR
  • 2 or more high-risk features; OR
  • More than 4 cores with Grade Group 4 or Grade Group 5; OR

Genetic Testing for Breast, Ovarian and Pancreatic Cancer Susceptibility

Effective Date: 03/23/2023
Revision Date: 03/23/2023
Review Date: 03/23/2023
Policy Number: HUM-0536-023
Page: 6 of 42

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Genetic Testing for Breast, Ovarian and Pancreatic Cancer Susceptibility

Effective Date: 03/23/2023
Revision Date: 03/23/2023
Review Date: 03/23/2023
Policy Number: HUM-0536-023
Page: 7 of 42

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Has an affected first- or second-degree relative diagnosed with breast cancer who meets the Hereditary Breast Cancer – Affected Individual above (except the criterion "mutation identified on tumor genomic testing that has clinical implications if also identified in the germline"); OR

Has an affected first- or second-degree relative diagnosed with ovarian cancer; OR

USPSTF recognized risk stratification tool indicates greater than 5% probability for a BRCA1/2 pathogenic variant

Hereditary Breast Cancer – Known Familial Pathogenic or Likely Pathogenic Variant

Humana members may be eligible under the Plan for hereditary breast cancer KFV genetic testing when the following criteria are met:

• Pre- and post-test genetic counseling; AND
• Has an affected first-, second- or third-degree relative with a pathogenic or likely pathogenic variant in the BRCA1, BRCA2, CDH1, PALB2, PTEN or TP53 genes (genetic testing should be limited to the KFV)

HEREDITARY OVARIAN, FALLOPIAN TUBE OR PERITONEAL CANCER – CORE GENES BRCA1, BRCA2, CDH1, PALB2, PTEN AND TP53

Hereditary Ovarian, Fallopian Tube or Peritoneal Cancer – Affected Individual

Humana members may be eligible under the Plan for sequencing and/or deletion/ duplication analysis (performed concurrently or sequentially) for hereditary ovarian cancer when the following criteria are met:

• Pre- and post-test genetic counseling; AND
  • Single gene testing of BRCA1, BRCA2, CDH1, PALB2, PTEN or TP53 genes; OR
  • Genomic sequencing and/or deletion/duplication analysis panel that includes 2 or more core genes BRCA1, BRCA2, CDH1, PALB2, PTEN and/or TP53 genes; AND

Genetic Testing for Breast, Ovarian and Pancreatic Cancer Susceptibility

Effective Date: 03/23/2023
Revision Date: 03/23/2023
Review Date: 03/23/2023
Policy Number: HUM-0536-023
Page: 8 of 42

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• Personal history of epithelial ovarian, fallopian tube or peritoneal cancer at any age (see testing strategy below for an individual of Ashkenazi Jewish ancestry*); OR
• Mutation identified on tumor genomic testing that has clinical implications if also identified in the germline; OR
• Does not meet above criteria and a USPSTF recognized risk stratification tool indicates greater than 5% probability for a BRCA1/2 pathogenic variant

Hereditary Ovarian, Fallopian Tube or Peritoneal Cancer – Unaffected Individual

Humana members may be eligible under the Plan for sequencing and/or deletion/duplication analysis (performed concurrently or sequentially) for hereditary ovarian cancer when the following criteria are met:

Refer to Hereditary Ovarian, Fallopian Tube or Peritoneal Cancer – Known Familial Pathogenic or Likely Pathogenic Variant section and Coverage Limitations section regarding KFV testing.

• Pre- and post-test genetic counseling; AND
• Individual to be tested is unaffected; AND
• An affected first- or second-degree relative is unavailable for genetic testing (eg, deceased, declines genetic testing or unable to contact); AND
  • Single gene testing of BRCA1, BRCA2, CDH1, PALB2, PTEN or TP53 genes; OR
  • Genomic sequencing and/or deletion/duplication analysis panel that includes 2 or more core genes BRCA1, BRCA2, CDH1, PALB2, PTEN and/or TP53; AND
• Ashkenazi Jewish ancestry* when the individual to be tested has a first- or second-degree relative diagnosed at any age with breast, epithelial ovarian, fallopian tube, peritoneal cancer, pancreatic or prostate cancer; OR

Genetic Testing for Breast, Ovarian and Pancreatic Cancer Susceptibility

Effective Date: 03/23/2023
Revision Date: 03/23/2023
Review Date: 03/23/2023
Policy Number: HUM-0536-023
Page: 9 of 42

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• Has a first- or second-degree relative diagnosed with epithelial ovarian, fallopian tube or peritoneal cancer at any age; OR
• Does not meet above criteria and a USPSTF recognized risk stratification tool indicates greater than 5% probability for a BRCA1/2 pathogenic variant

Hereditary Ovarian, Fallopian Tube or Peritoneal Cancer – Known Familial Pathogenic or Likely Pathogenic Variant

Humana members may be eligible under the Plan for hereditary ovarian, fallopian or peritoneal cancer KFV genetic testing when the following criteria are met:

• Pre- and post-test genetic counseling; AND
• Has an affected first-, second- or third-degree relative with a pathogenic or likely pathogenic variant in the BRCA1, BRCA2, CDH1, PALB2, PTEN or TP53 genes (genetic testing should be limited to the KFV).

HEREDITARY PANCREATIC CANCER – CORE GENES BRCA1, BRCA2, CDH1, PALB2, PTEN AND TP53

Hereditary Pancreatic Cancer – Affected Individual

Humana members may be eligible under the Plan for sequencing and/or deletion/duplication analysis (performed concurrently or sequentially) for hereditary pancreatic cancer when the following criteria are met:

• Pre- and post-test genetic counseling; AND
  • Single gene testing of BRCA1, BRCA2, CDH1, PALB2, PTEN or TP53 genes; OR
  • Genomic sequencing and/or deletion/duplication analysis panel that includes 2 or more core genes BRCA1, BRCA2, CDH1, PALB2, PTEN and/or TP53 genes; AND
• Personal history of exocrine pancreatic cancer at any age (see testing strategy below for an individual of Ashkenazi Jewish ancestry*); OR
• Personal history of neuroendocrine pancreatic tumors (nonfunctioning pancreatic tumors, gastrinoma, insulinoma, glucagonoma, VIPoma) at any

Genetic Testing for Breast, Ovarian and Pancreatic Cancer Susceptibility

Effective Date: 03/23/2023
Revision Date: 03/23/2023
Review Date: 03/23/2023
Policy Number: HUM-0536-023
Page: 10 of 42

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Hereditary Pancreatic Cancer – Unaffected Individual

Humana members may be eligible under the Plan for sequencing and/or deletion/duplication analysis (performed concurrently or sequentially) for hereditary pancreatic cancer when the following criteria are met:

• Pre- and post-test genetic counseling; AND
• Individual to be tested is unaffected; AND
• An affected first-degree relative is unavailable for genetic testing (eg, deceased, declines genetic testing or unable to contact); AND
  • Single gene testing of BRCA1, BRCA2, CDH1, PALB2, PTEN or TP53 genes; OR
  • Genomic sequencing and/or deletion/duplication analysis panel that includes 2 or more core genes BRCA1, BRCA2, CDH1, PALB2, PTEN and/or TP53; AND
• Ashkenazi Jewish ancestry* when the individual to be tested has a first- degree relative diagnosed at any age with exocrine pancreatic cancer; OR
• Has a first-degree relative diagnosed with exocrine pancreatic cancer at any age

Hereditary Pancreatic Cancer – Known Familial Pathogenic or Likely Pathogenic Variant

Humana members may be eligible under the Plan for hereditary pancreatic cancer KFV genetic testing when the following criteria are met:

Genetic Testing for Breast, Ovarian and Pancreatic Cancer Susceptibility

Effective Date: 03/23/2023
Revision Date: 03/23/2023
Review Date: 03/23/2023
Policy Number: HUM-0536-023
Page: 11 of 42

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• Pre- and post-test genetic counseling; AND

• Has an affected first-degree relative with a pathogenic or likely pathogenic variant in the BRCA1, BRCA2, CDH1, PALB2, PTEN or TP53 genes (genetic testing should be limited to the KFV)

LI-FRAUMENI SYNDROME (TP53 GENE)

Li-Fraumeni Syndrome – Affected Individual

Humana members may be eligible under the Plan for TP53 sequencing and/or deletion/duplication analysis (performed concurrently or sequentially) for LFS when the following criteria are met:

• Pre- and post-test genetic counseling; AND
• Individual to be tested meets classic LFS criteria, as demonstrated by the presence of ALL of the following:
  • Diagnosed with a sarcoma before 45 years of age; AND
  • First-degree relative diagnosed with cancer before 45 years of age; AND
  • An additional first-, or second-degree relative, on the same side of the family, diagnosed with cancer before 45 years of age or diagnosed with a sarcoma at any age; OR
• Individual to be tested meets Chompret criteria as demonstrated by the presence of at least 1 of the following:
  • Diagnosed with a tumor from LFS tumor spectrum (eg, soft tissue sarcoma, osteosarcoma, central nervous system [CNS] tumor, breast cancer, adrenocortical carcinoma) before 46 years of age, AND at least one first- or second-degree relative with any of the previously mentioned cancers (other than breast cancer if the proband has breast cancer) before 56 years of age or with multiple primaries at any age; OR

Genetic Testing for Breast, Ovarian and Pancreatic Cancer Susceptibility

Effective Date: 03/23/2023
Revision Date: 03/23/2023
Review Date: 03/23/2023
Policy Number: HUM-0536-023
Page: 12 of 42

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• Diagnosed with multiple tumors (except multiple breast tumors), 2 of which belong to LFS tumor spectrum (eg, soft tissue sarcoma, osteosarcoma, CNS tumor, breast cancer, adrenocortical carcinoma) with the initial cancer occurring before 46 years of age; OR
• Diagnosed with adrenocortical carcinoma or choroid plexus carcinoma or rhabdomyosarcoma of embryonal anaplastic subtype at any age of onset, regardless of the family history; OR
• Diagnosed with breast cancer before 31 years of age
• Individual to be tested diagnosed with pediatric hypodiploid acute lymphoblastic leukemia; OR
• Mutation identified on tumor genomic testing if clinical or family history is consistent with a pathogenic or likely pathogenic variant in the germline

Li-Fraumeni Syndrome – TP53 - Known Familial Pathogenic or Likely Pathogenic Variant

Humana members may be eligible under the Plan for TP53 KFV genetic testing when the following criteria are met:

• Pre- and post-test genetic counseling; AND
• Individual to be tested has an affected first-, second- or third- degree relative with a pathogenic or likely pathogenic variant in the TP53 gene (genetic testing should be limited to the KFV)

PTEN HAMARTOMA TUMOR SYNDROME/COWDEN SYNDROME (PTEN GENE)

PTEN Hamartoma Tumor Syndrome/Cowden Syndrome – Affected Individual

Humana members may be eligible under the Plan for PTEN sequencing and/or deletion/duplication analysis (performed concurrently or sequentially) for PHTS/CS (eg, Genomic Unity PTEN Analysis [0235U]) when the following criteria are met:

• Pre- and post-test genetic counseling; AND
• Individual to be tested does NOT meet PHTS Clinical Diagnostic Criteria and has a personal history of any of the following:
  • Adult Lhermitte-Duclos disease (cerebellar tumors); OR
  • Autism spectrum disorder and macrocephaly; OR
  • 4 or more minor PHTS/CS Testing Criteria; OR
  • 1 major and 3 or more minor PHTS/CS Testing Criteria (If an individual has 2 or more major criteria, such as breast cancer and nonmedullary thyroid cancer, but does not have macrocephaly, one of the major criteria may be included as 1 of the 3 minor criteria to meet testing criteria); OR
  • 3 or more major PHTS/CS Testing Criteria without macrocephaly; OR
  • 2 or more biopsy-proven trichilemmomas; OR
  • 2 or more major PHTS/CS Testing Criteria (one must be macrocephaly); OR
• Individual to be tested has a personal history of Bannayan-Ryile-Ruvalcaba syndrome (BRRS); OR
• Individual to be tested meets PHTS Clinical Diagnostic Criteria as demonstrated by:
  • 3 major criteria of the PHTS Clinical Diagnostic Criteria (one must include macrocephaly, Lhermitte-Duclos disease or gastrointestinal [GI] hamartomas); OR
  • 2 major and 3 minor criteria of the PHTS Clinical Diagnostic Criteria; OR
• Mutation identified on tumor genomic testing if clinical or family history is consistent with a pathogenic or likely pathogenic variant in the germline)

PTEN Hamartoma Tumor Syndrome/Cowden Syndrome – Unaffected Individual

Humana members may be eligible under the Plan for PTEN sequencing and/or deletion/duplication analysis (performed concurrently or sequentially) for

Genetic Testing for Breast, Ovarian and Pancreatic Cancer Susceptibility

Effective Date: 03/23/2023
Revision Date: 03/23/2023
Review Date: 03/23/2023
Policy Number: HUM-0536-023
Page: 14 of 42

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled.

Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

PHTS/CS (eg, Genomic Unity PTEN Analysis [0235U]) when the following criteria are met:

• Pre- and post-test genetic counseling; AND
• Individual to be tested is unaffected; AND
• An affected first-degree relative is unavailable for genetic testing (eg, deceased, declines genetic testing or unable to contact); AND
• Has a first-degree relative with a clinical diagnosis of PHTS, CS or BRRS; AND
  • Individual to be tested has the presence of one major criterion of PHTS/CS Testing Criteria; OR
  • Individual to be tested has the presence of two minor criteria of PHTS/CS Testing Criteria

PTHS – PTEN – Known Familial Pathogenic or Likely Pathogenic Variant

Humana members may be eligible under the Plan for PTEN KFV genetic testing when the following criteria are met:

• Pre- and post-test genetic counseling; AND
• Individual to be tested has an affected first-, second- or third-degree relative with a pathogenic or likely pathogenic variant in the PTEN gene (genetic testing should be limited to the KFV)

Ashkenazi Jewish ancestry is defined as having one grandparent identified as of Ashkenazi Jewish descent. In the absence of a KFV, testing begins with the 3 Ashkenazi Jewish founder specific mutations (BRCA1 185delAG, BRCA1 5382insC and BRCA2 6174delT). If negative, proceed to single gene testing or targeted multigene panel that includes 2 or more core genes. The terms male and female refer to sex assigned at birth although these might not align with how an individual identifies.

Genetic Testing for Breast, Ovarian and Pancreatic Cancer Susceptibility

Effective Date: 03/23/2023
Revision Date: 03/23/2023
Review Date: 03/23/2023
Policy Number: HUM-0536-023
Page: 15 of 42

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Coverage Limitations

Humana members may NOT be eligible under the Plan for genetic testing for breast, ovarian and pancreatic cancer susceptibility for the following:

• Deletion/duplication analysis is obtained as part of the sequencing procedure but submitted as an independent analysis
• Individual to be tested has an affected first-, second- or third-degree relative with a negative genetic testing result for the associated condition
• Individual to be tested is unaffected and an affected first-, second- or third- degree relative who is available for genetic testing
• KFV detection analysis if the individual to be tested previously received KFV testing, single gene analysis or multigene panel testing that would have detected the KFV

These are considered not medically necessary as defined in the member's individual certificate. Please refer to the member's individual certificate for the specific definition.

Humana members may NOT be eligible under the Plan for genetic testing for breast, ovarian or pancreatic cancer susceptibility for any indications other than those listed above. This is considered experimental/investigational as it is not identified as widely used and generally accepted for any other proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language.

Additional information about hereditary breast, ovarian and pancreatic cancer may be found from the following websites:

Background

• American Cancer Society
• National Library of Medicine

Medical Alternatives

Genetic Testing for Breast, Ovarian and Pancreatic Cancer Susceptibility

Effective Date: 03/23/2023
Revision Date: 03/23/2023
Review Date: 03/23/2023
Policy Number: HUM-0536-023
Page: 16 of 42

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled.

Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• Frequent screening with mammography or breast magnetic resonance imaging (MRI) (please refer to Breast Imaging Medical Coverage Policy)
• Review of an individual’s medical and family history

Alternatives to multigene panels include, but may not be limited to, the following:

• Targeted gene testing for specific hereditary cancer syndromes based on personal and family history

Physician consultation is advised to make an informed decision based on an individual’s health needs.

Humana may offer a disease management program for this condition. The member may call the number on his/her identification card to ask about our programs to help manage his/her care.

Any CPT, HCPCS or ICD codes listed on this medical coverage policy are for informational purposes only. Do not rely on the accuracy and inclusion of specific codes. Inclusion of a code does not guarantee coverage and or reimbursement for a service or procedure.