of settings, Dr. Bassano noted, including hospitals, physician offices, and independent labs.

For a medical intervention to qualify as reasonable and necessary, evidence must show, among other considerations, that the item or service improves clinically meaningful health outcomes in Medicare beneficiaries (CMS, 2009c). Evidence is assessed using standard principles of evidence-based medicine. CMS generally follows the evaluation process developed by other agencies or advisory bodies, such as AHRQ, USPSTF, and EGAPP. Genetic test coverage determinations are particularly challenging because genetic tests can be used for both diagnostic and screening purposes, Dr. Roche said. In addition, the evidence base is small for genetic tests, and the science is evolving. “The ultimate health outcomes attributable to genomic testing are not clear at this time,” Dr. Roche said, and there can be dangers in making some coverage determinations prematurely.

More recently, CMS has begun using criteria for Analytic validity; Clinical validity; Clinical utility; and Ethical, legal, and social implications (ACCE) (CDC, 2009) in making decisions on whether sufficient evidence exists to justify coverage of predictive tests. However, CMS has not yet formally adopted the ACCE framework or any other framework of evidence for predictive testing. In general, CMS rates evidence according to health outcomes. Diagnostic tests that lead to longer life expectancy, improved function, or significant symptom improvement are rated higher than tests that result in doctor confidence or earlier detection without improved survival (Box 1).

Some Medicare coverage decisions are made at the national level of the organization, but approximately 85 to 90 percent of coverage decisions are made by local contractors (CMS, 2009b). Local contractors can increase national coverage and reimburse additional procedures. For example, some local contractors cover gene marker tests for hereditary cancer syndromes, including ovarian cancer and colorectal cancer, assuming certain conditions are met (i.e., the individual is clinically affected by the disorder and is willing to undergo pretest genetic counseling). While some contractors do not cover these gene marker tests, local coverage of genetic analyses must be provided through a laboratory that meets ASCO’s recommended requirements, and the patient must sign an informed consent form prior to testing.

Dr. Ratain pointed out that because laboratories can receive samples for testing from all over the country, some local coverage decisions have national ramifications. For example, a California Medicare contractor made

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