Harvard Pilgrim would like to make providers aware of some updates to the coverage criteria in several of the clinical guidelines maintained by AIM Specialty Health, which oversees our prior authorization program for molecular genetic tests. These changes apply for our commercial and Medicare Advantage products. For complete information, refer to Harvard Pilgrim’s Molecular Diagnostic Management Medical Review Criteria and AIM’s updated clinical guidelines.
Hereditary Cancer Susceptibility
Genetic testing of BRCA1/2, ATM, and PALB2 are now considered medically necessary and covered with prior authorization for the treatment of individuals with localized stage III (National Comprehensive Cancer Network [NCCN] high-risk and very high-risk group), regional or metastatic prostate cancer.
Pharmacogenetic and Thrombophilia
In addition to the existing covered indications on the policy, testing for common variants in Factor V Leiden (F5) and prothrombin (F2) is now covered for individuals with an unprovoked venous thromboembolism (VTE) when test results will impact long-term medication management and at least one of the following applies:
- There is concern for homozygous F2 or F5 or compound heterozygous F2/F5
- The annual risk of recurrent VTE is estimated to be between 5% and 10%
Reproductive Carrier Screening and Prenatal Diagnosis
- For a prenatal cell-free DNA screening to be covered for a single-gestation pregnancy, the 10-week gestation age limit has been removed.
- Cases with a known co-twin demise (vanishing twin syndrome) are no longer excluded from coverage of prenatal cell-free DNA screening.
- Criteria for carrier screening was expanded to include coverage for additional rare genetic variants for conditions common in certain ethnicities. Carrier screening for additional conditions may be considered medically necessary if the patient is at increased risk to be a carrier based on their ethnicity, including but not limited to:
- Tay-Sachs carrier screening for individuals with French Canadian ancestry
- Maple syrup urine disease screening for individuals with Mennonite ancestry
Single-Gene and Multifactorial Conditions
While the required criteria for coverage of genetic testing with a single-gene panel remains unchanged, the criteria that must be met in order for genetic testing with a multi-gene panel to be covered no longer includes the requirement that the patient has been evaluated by a board-certified medical geneticist, genetic counselor, or other specialist with specific expertise in the genes and conditions being tested for.
Genetic testing with a multi-gene panel is medically necessary when all the single-gene testing criteria listed on the policy are met, as well as both of the following:
- The test is as targeted as possible for the clinical situation (i.e. does not include genes or mutations that are not clinically reasonable for the specific scenario)
- Clinical presentation warrants testing of multiple genes
Somatic Tumor Testing
- The criteria were expanded to include coverage of somatic genetic testing for uveal melanoma when the patient meets the testing criteria outlined in the relevant NCCN Clinical Practice Guidelines in Oncology.
- Gene expression or molecular profiling assays for confirmed prostate tumors are considered experimental and investigational and not covered.
- The criteria for coverage of MammaPrint to assess the risk for recurrence in a woman has been revised to include:
- Breast tumor is stage 1 or stage 2
- Patient is at high clinical risk for recurrence based on the MINDACT categorization.