American Association for Clinical Chemistry
Better health through laboratory medicine

AACC NEWS RELEASE
FOR IMMEDIATE RELEASE
Contact: Peter Patterson
(202) 835-8718
800-892-1400 ext. 1718
Email: ppatterson@aacc.org

Friday, May 13, 2011
AACC Announces Webinar: The Changing World Of Genetic Testing - Get The Latest On Regulatory And Payment Changes

Washington, DC – May 3, 2011         The American Association for Clinical Chemistry (AACC) and American Society for Clinical Laboratory Science (ASCLS) announce a webinar, The Changing World of Genetic Testing - Get the Latest on Regulatory and Payment Changes, to be held on June 14 at 2:00pm 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 Food & Drug Association (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, IL. 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, MD, who will talk on CMS Regulation Of Genetic Testing; and Charles Root, PhD, CEO of CodeMap in Chicago, IL, who discusses Payments Issues involving Genetic Testing.

AACC and ASCLA invite journalists reporting on health, Medicare or Medicaid issues to participate in this important and timely webinar that will examine federal efforts to regulate genetic testing, focusing on where we are today and where we may be going in the future. The webinar will also outline what government and private payers are doing in regards to genetic testing payments, as well as what new coding changes will mean for the laboratory. For a complimentary registration, complete and submit a Press Registration Form. For more information about the webinar or AACC, contact Peter Patterson on either of the above phone numbers or at ppatterson@aacc.org.

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AACC is a leading professional society dedicated to improving healthcare through laboratory medicine. Its over 9,000 members are clinical laboratory professionals, physicians, research scientists, and others involved in developing tests and directing laboratory operations. AACC brings this community together with programs that advance knowledge, expertise, and innovation.