The American Association for Clinical Chemistry (AACC) and American Society for Clinical Laboratory Science (ASCLS) will host an upcoming Webinar entitled, “[removed]The Changing World of Genetic Testing—Get the Latest on Regulatory and Payment Changes[/removed],” which will be held on June 14 at 2 pm Eastern. The Webinar will last 90 minutes.
Genetic testing remains a key issue for regulators and payers alike. As both groups work to ensure that the tests are safe, accurate, and meaningful, this increasingly means more oversight. On the regulatory side, the FDA and the Centers for Medicare & Medicaid Services (CMS) are working to ensure the efficacy and appropriateness of genetic tests. The FDA is currently working on guidance to regulate all laboratory-developed tests as medical devices. While this broader policy is under development, the agency is taking specific actions against Direct-to-Consumer (DTC) genetic tests that make unsubstantiated medical claims. CMS is also vigorously working to ensure that those DTC labs subject to Clinical Laboratory Improvement Amendments ’88 (CLIA ’88) are in compliance. Many Medicare contractors are concerned about the use of methodology-based code descriptions in place of the name of the test performed. Some have even stopped paying for genetic tests unless additional information is provided. The American Medical Association is working to address this concern and recently announced some of the changes it plans for 2012.
The Webinar will be moderated by Robert Murray, JD, PhD, Director of Technology at Midwest Diagnostic Pathology, in Chicago. The expert panel features Alberto Gutierrez, PhD, Director of the Office of In Vitro Diagnostic Device Evaluation & Safety at the FDA in Silver Spring, Md, who will discuss FDA Regulation Of Genetic Testing; Judy Yost, MA, MT (ASCP), Director of the Division of Laboratories at CMS in Baltimore, who will talk on CMS Regulation Of Genetic Testing; and Charles Root, PhD, CEO of CodeMap in Chicago, who discusses Payments Issues involving Genetic Testing.
