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| Medical Policy: | L-215-002 |
| Topic: | PALB2 Genetic Testing for Breast Cancer Risk |
| Section: | Laboratory |
| Effective Date: | July 1, 2018 |
| Issue Date: | July 2, 2018 |
| Last Reviewed: | March 2018 |
Breast cancer is the most frequently diagnosed malignancy and the leading cause of cancer mortality in women around the world. Hereditary breast cancer accounts for 5% to 10% of all breast cancer cases.In particular, two cancer susceptibility genes, BRCA1 and BRCA2, are implicated in about 20% of all hereditary breast cancer cases. Other genes have also been identified in the literature; in particular, PALB2 is a gene that encodes a protein that may be involved in tumor suppression, and is considered a partner and localizer of BRCA2. Specifically, ~50 truncating mutations in PALB2 have been detected among breast cancer families worldwide. |
This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.
| Policy Position Coverage is subject to the specific terms of the member’s benefit plan. |
Known Familial Mutation Analysis
PALB2 genetic testing for a known familial mutation analysis may be considered medically necessary when ALL of the following are met:
· Genetic Counseling:
o Pre- and post-test genetic counseling by an appropriate provider (as deemed by the Health Plan policy); and
· Previous Genetic Testing:
o No previous full sequence testing or deletion/duplication analysis; and
o Known family mutation in PALB2 identified in 1st, 2nd, or 3rd degree relative(s); and
· Age 18 years or older.
Full Sequence Analysis
Full sequence analysis of the PALB2 gene may be considered medically necessary when ALL of the following are met:
- Member has not had previous PALB2 genetic testing; and
- Member has met criteria for BRCA1/2 analysis;** and
- Member has had BRCA1/2 analysis and no mutations were found
**Please see the guideline BRCA Analysis for criteria
| Professional Statements and Societal Positions |
The National Comprehensive Cancer Network (NCCN, 2017) includes breast cancer risk and management recommendations for individuals with PALB2 in a table located in their Genetic/Familial High-Risk Assessment: Breast and Ovarian guideline. However, it is noted that, “The inclusion of a gene on this table below does not imply endorsement either for or against multi-gene testing for moderate penetrance genes.” Recommendations are as follows:
The European Society for Medical Oncology (ESMO, 2016) states the following prevention and screening strategies for individuals with a PALB2 mutation:
ESMO (2016) also states the following regarding PALB2 testing, “The following genes might have moderate- to high-penetrance germline mutations for breast or ovarian cancer: p53, PTEN, CDH1, PALB2, CHEK2, ATM, RAD51C, STK11, RAD51D, BRIP1, MLH1, MSH, MSH6, and PMS2. Prevention and screening strategies for these mutations are summarized in Table 1 – due to limited research in individuals harboring these mutations, the level of evidence for these recommendations is mostly expert opinion, and a full discussion is beyond the scope of these guidelines.” The Second International Consensus Conference for Breast Cancer in Young Women (BCY2, 2016) led to publication of consensus recommendations. The following is stated regarding PALB2 genetic testing:
A review of the available PALB2 literature revealed the following:
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| Place of Service: Outpatient |
PALB2 testing is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.
| The policy position applies to all commercial lines of business |
| Denial Statements |
Services that do not meet the criteria of this policy will not be considered medically necessary. A network provider cannot bill the member for the denied service unless: (a) the provider has given advance written notice, informing the member that the service may be deemed not medically necessary; (b) the member is provided with an estimate of the cost; and (c) the member agrees in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.
| Links |
- Link to Provider Resource Center for the Medical Policy Update
05/2018, REMINDER: Molecular and Genomic Testing
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Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.
Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:
- Provides free aids and services to people with disabilities to communicate effectively with us, such as:
- Qualified sign language interpreters
- Written information in other formats (large print, audio, accessible electronic formats, other formats)
- Provides free language services to people whose primary language is not English, such as:
- Qualified interpreters
- Information written in other languages
If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.
You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:
U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)
Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.
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