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CMS Says Genetic-Testing Specialty Under CLIA Rules Forthcoming

NEW YORK, March 7 (GenomeWeb News) -The Centers for Medicaid and Medicare said today that a genetic-testing-specific set of standards is currently in clearance at the agency.

 

"There will be a regulation forthcoming," a CMS official told GenomeWeb News today. "It is a proposed rule that will solicit comments from the public."

 

There is currently no genetic testing specialty under the Clinical Laboratory Improvement Amendments. As GenomeWeb News reported last week, the Genetic Alliance urged CMS to establish such a specialty as proposed by the Centers for Diseases Control and Protection in 2000.

 

The CMS official told GenomeWeb News that the proposal would now be vetted by CMS, the CDC, the Office of Management and Budget, Health and Human Services, and the Food and Drug Administration.

 

The official could not give a timeline for clearance of the rule.