BIO Comments on 2013 Gapfill Payment Amounts CLFS

The Biotechnology Industry Organization (BIO) appreciates the opportunity to submit comments on the "Notification of Comment Period- 2013 Gapfill Payment Amounts Clinical Laboratory Fee Schedule (CLFS)" published by the Centers for Medicare and Medicaid Services (CMS) on May 9, 2013. BIO supports patient access to high-quality, innovative diagnostic tests for actionable biomarkers (i.e., tests used to inform clinical decision making). Acces to high-quality diagnostic testing is the cornerstone of personalized medicine, ensuring the right patients are treated with the right drug at the right time. Our members are concerned that the recent payment determination process for these tests will adversely impact access to these tests. The quality of care for patients with serious conditions will be compromised by impeding the use of molecular diagnostics to help determine the right medicine for the right patient.