Results 11 to 15 of 15

Anticipated framework for regulatory oversight of laboratory developed tests

USA - August 6 2014 Historically, the U.S. Food and Drug Administration (FDA) has exercised enforcement discretion with respect to most laboratory-developed tests (LDTs)…

Michael W. Ryan, John Warren, Eric Zimmerman

CMS take steps to modernize clinical lab policies

USA - February 11 2014 Through two recently issued regulations, the Centers for Medicare and Medicaid Services have announced their intention to reform and improve Medicare…

John Warren, Eric Zimmerman

FDA issues draft guidance, requests public comments on communication of off-label information

USA - January 4 2012 The U.S. Food and Drug Administration is evaluating its policies regarding the communication of off-label information for drugs, biologics and devices, with the issuance of a draft guidance and the opening of a docket for public comments.

Glenn Engelmann, Susan S. Lee, Michael W. Ryan

CMS finalizes several changes for skin substitutes in CY 2015 outpatient prospective payment system final rule

USA - November 17 2014 On October 31, 2014, the Centers for Medicare & Medicaid Services (CMS) released its annual final rule (Final Rule) setting the payment rates and…

Elizabeth K. Isbey

CMS proposes to retract new physician lab signature requirement

USA - July 7 2011 In a proposed rule published in the June 30, 2011, Federal Register, the Centers for Medicare and Medicaid Services proposed to retract a recently established policy requiring physician signatures on laboratory requisitions. 

Amy Hooper Kearbey, Joan Polacheck, Eric Zimmerman