CMS rejects new safety standards petition for genetic-testing labs.In a joint press release issued in September, the Genetics and Public Policy Center, the Genetic Alliance, and Public Citizen announced that the Centers for Medicare and Medicaid Services The Centers for Medicare and Medicaid Services (CMS), previously known as the Health Care Financing Administration (HCFA), is a federal agency within the United States Department of Health and Human Services (DHHS) that administers the Medicare program and (CMS (1) See content management system and color management system. (2) (Conversational Monitor System) Software that provides interactive communications for IBM's VM operating system. ) rejected on Aug. 30, 2007, their September 2006 petition calling for the agency to exercise its authority under the Clinical Laboratory Improvement Amendments Clinical Laboratory Improvement Amendments (CLIA) of 1988 are United States federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States, except clinical trials and basic research. of 1988 (CLIA CLIA Clinical Laboratory Improvement Amendments of 1988 Congressional legislation that promulgated quality assurance practices in clinical labs, and required them to measure performance at each step of the testing process from the beginning to the end-point of a '88) to strengthen standards for genetictesting laboratories. CMS also had received letters from nearly 100 organizations, including healthcare providers, patients, and industry, requesting that the agency create enhanced genetic-testing regulations. The petition sought to increase the use of proficiency testing by requesting the creation of a "specialty" for genetic testing. Citing cost concerns, the agency told petitioners in a recent letter that it would not pursue the safety standards. CLIA '88 requires the Secretary of the Department of Health and Human Services Noun 1. Department of Health and Human Services - the United States federal department that administers all federal programs dealing with health and welfare; created in 1979 Health and Human Services, HHS to set standards for laboratories to ensure their quality, including standards for "proficiency testing." Proficiency testing provides independent confirmation that the lab can get the right answer reliably when performing laboratory tests. CMS, however, has not mandated participation in proficiency testing for genetic-testing laboratories. Genetic tests are currently available clinically for more than 1,100 diseases. In denying the petition for rulemaking, CMS stated that few proficiency-testing programs exist and that the barriers to expanding the number were "technological and financial," rather than regulatory. According to the press release, the College of American Pathologists This article or section needs sources or references that appear in reliable, third-party publications. Alone, primary sources and sources affiliated with the subject of this article are not sufficient for an accurate encyclopedia article. (CAP) now offers proficiency testing for more than two dozen genetic tests, including widely used tests such as cystic fibrosis and Factor V Leiden factor V Leiden Hematology A variant of factor V present in 3%-8% of Caucasians associated with a ↑ risk of DVT. See LETS, Hereditary thrombophilia. , but laboratories currently are not required to enroll in them. Mandatory requirements would result in more proficiency tests being developed, the petition argued. To support its contention that developing new proficiency-testing programs is too difficult, CMS points to its experience with Pap smears, stating that it took 17 years from the passage of CLIA '88 to develop a nationwide proficiency-testing program. CMS' response also dismissed reports from three federal advisory groups over the past decade recommending that the agency strengthen genetictesting oversight. |
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