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Coverage and Reimbursement of 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 Human Genome Research Institute (NHGRI), recently 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 To view the PowerPoint presentation on this page you'll need PowerPoint Viewer 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). The Secretary's Advisory
Committee on Genetics, Health, and Society (SACGHS) recently 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. To view the PDF on this page you will need Adobe Reader.
Last Updated: May 15, 2009 |
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