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Smith Questions CMS' Failure to Ensure Competency of Genetic Testing Labs
 
October 31st, 2006 - Washington, DC - Calling into question the failure of the Centers for Medicare and Medicaid Services (CMS) to create a genetic testing specialty under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), Chairman Gordon H. Smith (R-OR) urged Secretary Michael Leavitt of the Department of Health and Human Services (HHS) to take action. Chairman Smith recently conducted a hearing in the Senate Special Committee on Aging that exposed weaknesses in the regulation of at-home genetic testing products, leading to the fraudulent marketing of some of these products to consumers. (see hearing “At Home DNA Tests: Marketing Scam or Medical Breakthrough” at http://aging.senate.gov/public/index.cfm?FuseAction=Hearings.Home.)

“With a few clicks on the internet, consumers now can purchase at-home tests that claim to predict propensities for a myriad of health conditions, including Alzheimer’s, cancer, diabetes and arthritis,” said Chairman Smith. “However, as we learned from the Aging Committee’s July hearing, many of these home tests are misleading and exploiting consumers.”

“The responsibility for ensuring the quality of genetic testing laboratories rests squarely with CMS. The Administration’s inaction to create a genetic testing specialty under CLIA is fostering an environment that is ripe for consumer fraud and abuse.”

On May 4, 2000, HHS published a Notice of Intent in the Federal Register announcing its intent to issue a proposed rule to create a genetic testing specialty under CLIA. In April 2006, HHS placed the issuance of a proposed rule on its Semiannual Regulatory Agenda, with a target release date for a notice of proposed rulemaking in November 2006. However, CMS officials have now stated their intent to abandon efforts to develop tailored standards for genetic testing laboratories.

To ensure the industry does not continue to operate without adequate oversight, Chairman Smith called upon Secretary Leavitt to make certain that a notice of proposed rulemaking is issued by January 31, 2007, with a final rule to be issued after an adequate public comment period. Chairman Smith required written explanation by November 30, 2006 regarding whether HHS will move forward with issuance of a genetic testing specialty, and if not, the reasons for that decision.


 


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