BRCA genetic counseling and testing for women

Under the Patient Protection and Affordable Care Act (ACA), most health insurers are required to pay for BRCA genetic counseling and testing for women who meet certain personal and/or family history criteria. If you meet the testing requirements, insurance companies must cover the entire cost of genetic counseling and BRCA testing with no out-of-pocket costs to you. 

The ACA does not require coverage of genetic counseling and testing for people who do not meet the U.S. Preventive Services Task Force (USPSTF) guidelines, including:

• Genetic counseling or testing for people with a family history that suggests Lynch Syndrome (associated with colon, uterine and ovarian cancer) or other hereditary cancer syndromes
• Genetic testing for genes other than BRCA1 and BRCA2 (i.e., ATM, CHEK2, PALB2, etc.)
• Genetic counseling and testing for men

Most private group and individual health insurers cover genetic testing for people who don't meet the USPSTF BRCA testing criteria but deductions, consinsurance and copays typically apply. 

Note that the ACA does not apply to Medicare or Medicaid. They have their own rules. See the Insurance & Reimbursement section of our website to learn more.

Filing a genetic testing lab complaint

CLIA

All clinical laboratory testing performed on humans in the U.S. (except in clinical trials and basic research) is overseen by the Clinical Laboratory Improvement Amendments (CLIA).

If you have concerns or want to file a complaint against a lab that conducted genetic testing, you or your health care provider should reach out to your state CLIA contact. 

All other questions or concerns about the CLIA program should be submitted to [email protected].

FDA

The Food and Drug Administration (FDA) also tracks adverse (negative) events and concerns about laboratory tests through MedWatch: The FDA Safety Information and Adverse Event Reporting Program. Patients or health care providers can report adverse events to the FDA.