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By Scott Roberts On November 28, 2012, the Food and Drug Administration (“FDA”) issued draft guidance outlining an Institutional Review Board’s (“IRB”) responsibility for evaluating the qualifications of clinical investigators that are subject to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 …

OIG Finds Tennessee’s Amended False Claims Act Too Narrow, Requiring Tennessee to Go Back to the Drawing Board Again

By Rodney D. Butler Within the last few weeks, the Office of Inspector General (OIG) issued a letter to the State of Tennessee regarding its Medicaid Fraud False Claims Acts. Unfortunately for the State of Tennessee, the OIG provided notice that their statutory framework failed to meet the requirements of section 1909 of the Social …

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 …

Criminal Action Taken Against Vermont Ultrasound Technologist for Accessing Records Without Authorization

By Tatiana Melnik The Rutland Herald of Vermont, reports that Kathy Tatro was sentenced in a Bennington, Vermont criminal court on Friday, November 23, 2012, to a suspended jail term of 6 to 12 months, 2 years of probation, 160 hours of community service, a $2,000 fine, and ordered to write a letter of apology …