Improvement Needed in Genetic Testing Oversight
WASHINGTON, D.C. — In recent months many health-related organizations have joined in calling on the Centers for Medicare and Medicaid Services (CMS) to end years of delay in assuring the safety and accuracy of genetic testing. In separate letters to CMS Administrator Mark McClellan, members of Genetic Alliance and a coalition of women's health groups urged the agency to issue a proposed rule to create a genetic testing specialty under the Clinical Laboratory Improvement Amendments (CLIA) of 1988. The agency published a notice of intent to propose a rule in 2000, and the delay has meant that scientific and technological advances in genetic testing have outpaced the government's ability to provide adequate oversight, the organizations maintain. CMS, an agency of the U.S. Department of Health and Human Services, administers CLIA. CLIA was enacted to ensure that clinical laboratory tests, such as those used for blood sugar, urinalysis, or HIV infection, are accurate and reliable and that physical conditions at the laboratories meet certain expectations.
The Genetics and Public Policy Center sent a letter to McClellan in November of last year, and Genetic Alliance President and CEO Sharon Terry wrote to the administrator in February to encourage speedy implementation of a genetic testing specialty. A third letter, sent in June, grew out of a luncheon the Center hosted for advocates for people with genetic diseases. Convinced of the need for quality assurance in genetic testing, 75 organizations ultimately signed the letter. These ranged from the National Association of Social Workers, to the Trisomy 18 Foundation, to Affymetrix, Inc.
The second letter originated with meeting convened by the Center, the Reproductive Health Technologies Project (RHTP), and Haddasah. Leaders from the women's health advocacy community met to discuss genetic testing oversight and its implications for women and families. RHTP then drafted the letter, which was signed by 14 organizations including the Association of Reproductive Health Professionals, Hadassah, the National Organization for Women, and Planned Parenthood.
For more information, visit the Web site of the Genetics and Public Policy Center.