Abstract

1. Kathy Hansen 2. Don Lavanty An ongoing activity of the Government Affairs Committee of the American Society for Clinical Laboratory Science (ASCLS) is to respond to changes in laboratory regulations that are proposed by the Centers for Medicare and Medicaid Services (CMS) and other federal agencies. Typically regulations are published in the Federal Register in a proposed form, with a deadline for comments to be submitted. CMS then takes comments under advisement before a revised final regulation is published. Depending upon the volume of comments received, this process can take from a few months to many months before final regulations are published. Such responses to requests for comments are submitted several times each year. ASCLS tries to take every opportunity to express your views in the regulatory process. A recent example is a proposed rule published on August 5, 2004 in the Federal Register Vol. 69, #150 titled Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2005. The rules will implement the new cardiovascular and diabetes screening provisions mandated by the Medicare Prescription Drug and Modernization Act of 2003 (MMA). In September, ASCLS submitted comments which commended CMS for the thorough, thoughtful process that was followed to solicit input concerning the types of tests to be covered for Diabetes and Cardiovascular Risk Screening. Excerpts from the ASCLS comments follow. Note that they focus on both scientific reasoning as well as practical operational considerations for laboratories. Whenever possible, ASCLS tries to coordinate its comments and opinions with other laboratory professional…

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