Clarifying an IRB’s Review of a Clinical Investigators’ Qualifications

By Scott Roberts On November 28, 2012, the Food and Drug Administration (“FDA”) issued draft guidance outlining an Institutional Review Board’s (“IRB”) responsibility for evaluating the qualifications of clinical investigators that are subject to Investigational New Drug (“IND”) regulations. The new guidance clarifies the role IRBs play in reviewing the qualifications of an investigator, which …

Medicare Finalizes 2013 Physician Payment Schedule

By Ralph Levy, Jr. On November 1, 2012, the Centers for Medicare & Medicaid Services (CMS) finalized previously announced changes to the Medicare Physician Fee Schedule (MPFS) for services furnished by physicians during calendar year 2013. These payment changes will affect different specialties in different ways. For example, payments to family physicians will increase by …