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Genetic testing for cancer susceptibility involves identifying well-characterized genetic variants based on clinical evidence that has identified genes associated with a high risk of heritable cancer. Genes included in a panel must be relevant to the personal and family history of the individual being tested, clinically actionable, and provide necessary information for clinical decision making.
The majority of commercially available genetic test panels use next-generation sequencing (NGS) or technologies that allow for the analysis of multiple genes at one time. Some of these panels address types of cancer that have a well-defined hereditary component, including breast, ovarian, endometrial, colon, pancreatic and renal cancers. Comprehensive panels are also available that include genetic variants associated with moderate, low, or unknown levels of risk of developing cancer. A limited number of variants are associated with higher risk of well-defined cancer syndromes for which clinical management guidelines are available. Clinical management recommendations for the genetic variants associated with low-to-intermediate or unknown risk of cancer are generally not standardized and could potentially lead to harm, as high rates of variants of uncertain significance have been reported with the use of these panels.
Definitions
Genetic Testing: Genetic testing involves the analysis of chromosomes, DNA, RNA, genes, or gene products to detect inherited (germline) or noninherited (somatic) genetic variants related to disease or health.
Pedigree: Genetic counseling often includes development of a pedigree, which is a diagram of genetic relationships and medical history of a family to determine inheritance patterns of genetic conditions. A pedigree used for purposes of risk assessment for a condition generally include a minimum of 3 generations.
Note: Testing for hereditary breast and ovarian cancer syndrome (BRCA1 and BRCA2 genes) including related panel testing is not addressed this policy. Please refer to policy VI-16: Genetic Testing for Hereditary Breast and/or Ovarian Cancer.
I. Genetic Counseling
Multigene cancer susceptibility panel testing may be considered MEDICALLY NECESSARY AND APPROPRIATE when ALL of the following criteria for genetic counseling are met along with criteria in section II:
*Genetics professionals are not excluded if they are employed by or contracted with a laboratory that is part of an Integrated Health System which routinely delivers health care services beyond the laboratory test itself.
II. Multigene Cancer Susceptibility Panels
Multigene cancer susceptibility panels may be considered MEDICALLY NECESSARY AND APPROPRIATE when criteria in Section I and ALL of the following are met:
III. Experimental/Investigative Testing
Multigene cancer susceptibility panels are considered EXPERIMENTAL/INVESTIGATIVE for all other indications, including but not limited to the following, due to a lack of clinical evidence demonstrating an impact on improved health outcomes:
0048U 0101U 0129U 0238U 0296U 0297U 0298U 0299U 0300U 81435 81436 81437 81438 81445 81450 81479 81599 Multiple codes apply
No additional statements
Blue Cross and Blue Shield of Minnesota medical policies apply generally to all Blue Cross and Blue Plus plans and products. Benefit plans vary in coverage and some plans may not provide coverage for certain services addressed in the medical policies. When determining coverage, reference the member’s specific benefit plan, including exclusions and limitations.
Medicaid products may provide different coverage for certain services, which may be addressed in different policies. For Minnesota Health Care Program (MHCP) policies, please consult the MHCP Provider Manual website.
Medicare products may provide different coverage for certain services, which may be addressed in different policies. For Medicare National Coverage Determinations (NCD), Local Coverage Determinations (LCD), and/or Local Coverage Articles, please consult CMS, National Government Services, or CGS websites.
Note that services with specific coverage criteria may be reviewed retrospectively to determine if criteria are being met. Retrospective denial of claims may result if criteria are not met.
Blue Cross and Blue Shield of Minnesota reserves the right to revise, update and/or add to its medical policies at any time without notice. Codes listed on this policy are included for informational purposes only and are subject to change without notice. Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement.
These guidelines are the proprietary information of Blue Cross and Blue Shield of Minnesota. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.
Acknowledgements:
CPT® codes copyright American Medical Association® 2022. All rights reserved.
CDT codes copyright American Dental Association® 2022. All rights reserved.
