Fraud Alert! Genetic test scams are a growing problem.
September 27, 2019 - Federal law enforcement agencies recently charged 35 individuals associated with dozens of telemedicine companies and cancer genetic testing laboratories for fraudulent genetic testing and Medicare billing practices. Scams are a growing problem. If you are considering DNA/genetic testing, there is important information that you should know first.
There is a flood of information available about genetic tests for cancer risk in the media, and even at community events, such as health fairs and senior centers. Genetic testing can provide important, life-saving information when done in the right way. If you are considering genetic testing to learn more about your hereditary cancer risk, or if you have already received genetic test results, consider speaking with a genetic counselor, doctor or other health care provider who has advanced training in genetics. This is the most reliable way to obtain and understand information about your risk.
Watch this brief video about genetic testing fraud.
Read the FORCE Blogs on this issue for more information and perspective:
- Alert: Cancer Genetic Testing Should be Performed in the Health Care Setting
- Protect Yourself, Your Friends and Family from Fraudulent Genetic Testing
Filing a Complaint
You have a right to know the name of the lab performing your genetic testing. Beware of representatives marketing tests in community settings or selling genetic tests for unnamed labs. Genetic tests are currently regulated by the FDA and CLIA. When ordering lab work such as a genetic test, health care providers typically order them through a trusted, CLIA-certified lab, which is regularly evaluated for quality assurance.
The FDA aims to ensure that test marketing materials and claims are accurate, and that they address the information needs of the approved audience—health care providers or the public. If you have concerns or a complaint about a laboratory, you or your health care provider can file a complaint.
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 LabExcellence@cms.hhs.gov
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.
3/31/2021 - Expressed support for legislation (S.5355/A.2151) that would establish genetic counseling as a licensed profession in the state of New York.
3/16/2021 - Signed on in support of the Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021 (H.R. 1946), which will give CMS authority to cover blood-based multi-cancer early detection tests and future test methods (like urine or hair tests), once approved by the FDA.
2/17/2021 - In a letter to President Biden, underscored the urgency of prioritizing access to the COVID-19 vaccine for patients with active cancer and survivors of cancer.
2/4/2021 - Joined a group of 75 orgs in a letter to HHS expressing concern that new Medicare Payment Modernization models proposed by the prior administration could jeopardize access to medically necessary prescription drugs and harm patients with serious illnesses.