Although FDA approval of a genomic medicine test may improve the likelihood of coverage by insurance companies, it is no guarantee. Whether or not an insurance plan covers genetic testing depends on several factors, including consumer demand, opinions of professional organizations, integration into clinical guidelines, and most importantly, the strength of evidence supporting a test’s analytical and clinical validity and clinical utility.
Private insurance plans all make their own decisions regarding whether to cover and how much to reimburse for a genomic test, but private insurers often mimic the coverage decisions of Medicare, as the largest provider of health insurance in the United States. Medicare decisions are made by the Centers for Medicare and Medicaid Services (CMS), which has a policy of reimbursing tests that are reasonable and necessary for diagnosis or treatment of an illness or injury. However, CMS does not typically reimburse screening tests, including genetic predisposition tests, except in the presence of signs and symptoms of disease. CMS’s Medical Evidence Development and Coverage Advisory Committee (MEDCAC) met in 2009 to discuss what types of evidence will be needed to evaluate screening genetic tests for Medicare coverage. This information should help guide future development of genomic tests to improve their likelihood of coverage.