BIO Comments on New CMS Clinical Lab Fee Schedule Codes and Payment Determinations

The Biotechnology Industry Organization (BIO) appreciates the opportunity to submit comments on the New and Reconsidered Clinical Laboratory Fee Schedule (CLFS) Test Codes and Preliminary Payment Determinations published by the Centers for Medicare and Medicaid Services (CMS) on August 31, 2012. BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnologies, thereby expanding the boundaries of science to benefit society by providing better healthcare, enhanced agriculture, and a cleaner and safer environment. Specifically related to advanced personalized diagnostic products, a number of BIO companies develop and market in vitro diagnostic technologies for a variety of research, investigational, and clinical uses. BIO is deeply concerned with CMS’ payment proposal regarding Multi-Analyte Assays with Algorithmic Analyses (MAAAs), and is concerned generally with the lack of transparency in the process through the annual CLFS meeting and publication of the proposed payment methodologies. BIO believes these proposed payments will threaten access to molecular pathology tests by Medicare beneficiaries and have a devastating impact on the advancement of personalized medicine.