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Coverage and Reimbursement of Genetic Tests

ChromosomesGenomic medicine has the capacity to revolutionize clinical practice, but if insurance companies and Medicare are unwilling to pay for genetic testing, this important progress will be stalled. The mapping of the human genome has created new opportunities for genetic tests to predict, prevent and treat disease. Tests such as BRCA 1 and 2 for breast cancer and HNPPC testing for colorectal cancer can assess disease risk and guide screening and preventive measures. Other tests can predict optimal chemotherapy regimens, or predict the likelihood of drug response or toxicities and avoid exposing patients to ineffective or overly toxic regimens. There are many other examples of clinically useful information available through newly developed genetic tests.

Reimbursement decisions about genetic testing are complicated by a lack of extensive data evaluating the economics of genetic testing, and by the cost of evaluating new technologies. Dr. Francis Collins, director of the National Institutes of Health and former director of the National Human Genome Research Institute (NHGRI), spoke at the World Health Congress (World Health Congress) in Washington, D.C., and commented on the need for further study of the economic benefit of genetic testing to predict, prevent and treat disease. (See: Genomic Medicine: A Revolution in Medical Practice in the 21st Century (PPT).

The Centers for Medicare and Medicaid Services (CMS) administers Medicare, the largest health insurance program in the United States. CMS also manages the Clinical Laboratory Improvement Amendments (CLIA)program, which inspects and regulates clinical laboratories, including those doing genetic testing (See: Clinical Laboratory Improvement Amendments).

Several government agencies are working towards the development of regulatory standards for genetic testing laboratories and comprehensive integration of genetic testing into routine medical care. The Centers for Disease Control has an advisory group specifically focused on the CLIA regulations, (See: Centers for Disease Control: Genetic Testing Policy), as well as projects studying validation of genetic tests and the integration of genetic tests into clinical practice. (See: Centers for Disease Control - Genetic Testing). In addition, the Secretary's Advisory Committee on Genetics, Health, and Society (SACGHS) issued a comprehensive coverage report summarizing the issues surrounding reimbursement of genetic tests. (See: Coverage and Reimbursement of Genetic Tests and Services. )

The NHGRI hopes to serve as a resource for advancing genomic medicine by assisting all types of payers in their efforts to evaluate emerging genetic tests for reimbursement, and by promoting research into the health benefit and cost-effectiveness of genetic testing.

Last Updated: May 2, 2016