Screening Genetic Tests

On May 6, 2009, CMS convened a public meeting of the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) entitled “Screening Genetic Tests”.

The Secretary’s Advisory Committee on Genetics, Health and Society (SACGHS) defines genetic testing as “…any test performed using molecular biology methods to test DNA or RNA, including germline, heritable, and acquired somatic variations.” Genetic screening test(s) are used for individuals who do not exhibit signs or symptoms of a disorder to detect possible diseases and for clinical uses. According to CMS, these tests are sweeping into the market despite the less than robust evidence to support these uses.

The meeting focused on the desirable characteristics of evidence that is needed to evaluate screening genetic test(s) for Medicare coverage. As such CMS wanted to determine whether genetic testing as a laboratory screening service improves health outcomes for the Medicare population. Specifically, does the screening genetic testing change the natural history and/or reduce the complications of the disease and alter morbidity/mortality.