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Genetic Testing Guideline Changes – Effective March 11, 2023

Effective for dates of service on and after March 11, 2023, AIM Specialty Health® (AIM) will transition to an updated set of Clinical Appropriateness Guidelines. 
 
PacificSource has partnered with AIM to help ensure quality care while reducing costs associated with genetic testing that is not evidence-based. In collaboration with our valued providers, our genetic testing program ensures our members have access to appropriate testing.

The details of the Clinical Appropriateness Guidelines updates are listed below, by testing category.

Hereditary Cancer Testing
  • Adds condition-specific criteria based on NCCN recommendations, as well as other clinical guidelines
  • Limits testing in the following scenarios:
    • prostate cancer (in select scenarios) for patients without additional familial risk
    • patients with only a second-degree relative with ovarian cancer  
    • patients with breast cancer and family history in some select scenarios (e.g., lobular histology only plus personal or family history of gastric cancer)
Somatic Tumor Testing
  • Clarifies criteria about tumor stage in cutaneous melanoma and cholangiocarcinoma, and about histology in non-small-cell lung cancer, ovarian cancer (epithelial) and prostate cancer (adenocarcinoma)
  • Chromosomal microarray analysis may require additional review.
  • Specifies the genes that must be included in panels for hematologic malignancy testing
  • Allows testing for patients with metastatic uveal melanoma 
  • Removes specific language regarding the brand names of tests that are considered medically necessary, and generally does not specifically name the therapeutic agents that must be under consideration, allowing reviewers to appropriately adjudicate when new therapies or tests are approved by the FDA 
Cell-free DNA Testing (Liquid Biopsy) for the Management of Cancer
  • Removes specific language regarding the brand names of tests that are considered medically necessary, and generally does not specifically name the therapeutic agents that must be under consideration, allowing reviewers to appropriately adjudicate when new therapies or tests are approved by the FDA 
Carrier Screening in the Prenatal Setting and Preimplantation Genetic Testing
  • Clarifies testing requirements for Fragile X Syndrome in patients with unexplained ovarian failure
  • Clarifies carrier screening restrictions for autosomal recessive conditions 
  • Expands selected relevant screening for patients at high risk based on ethnicity (e.g., Ashkenazi Jewish, French Canadian, Mennonite) and the conditions for which to test
  • Expands screening when one or both individuals do not have access to biological family history, and allows preimplantation testing when reproductive donor is of unknown carrier risk 
Genetic Testing for Inherited Conditions
  • Clarifies criteria on cardiomyopathies for which testing is medically necessary
  • Allows for broader panels for arrhythmia and cardiomyopathy syndromes 
Whole Exome Sequencing and Whole Genome Sequencing
  • Whole exome sequencing – Allows reanalysis using the same criteria as for the initial test

  • Whole exome sequencing – Limits testing for congenital bilateral hearing loss of unknown etiology, developmental and epileptic encephalopathy, and single anomaly with positive family history 

Use of Polygenic Risk Scores in Genetic Testing
  • Limits polygenic risk score testing
Pharmacogenomics Testing
  • Limits testing for patients being treated with warfarin 
  • Specifies biomarkers for which one-time testing is considered medically necessary
There are no substantive changes to the guidelines for:
  • Chromosomal Microarray Analysis
  • Prenatal Testing using cell-free DNA

 

Questions?

Please contact AIM via email at AIM.Guidelines@AIMSpecialtyHealth.com

Download or view current and upcoming guidelines​​​