Diagnostic Uses of Genetic Testing/Medicare Evidence Development and Coverage Advisory Committee

The minutes are available from the February 25, 2009 Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) meeting about the basis of evidence for coverage of genetic testing. Each of these two MEDCAC sessions will focus on a separate use of genetic testing:

• The first, in February 2009, seeks guidance on the types of evidence on which to base coverage decisions relating to diagnostic uses of genetic testing as it may apply to improving health outcomes in the Medicare beneficiary population.
• The second, tentatively scheduled for May 2009, will focus on screening uses of genetic testing and its potential application to Medicare beneficiaries.

In Question 3 proposed for MEDCAC consideration, the Committee may wish to consider several uses of genetic testing together or separately:

• Diagnostic assessment: for example, testing for the variant of the gene HD associated with Huntington’s disease
• Prognostic assessment: for example, assessment of gene expression in tumor tissue to evaluate likelihood of distant recurrence in patients with early-stage breast cancer
• Pharmacogenomic assessment: for example, testing for variants in the K-ras gene which indicated absent response to certain chemotherapy for colorectal cancer (e.g., cetuximab)