Paul W. Radensky
McDermott Will & Emery
Articles
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)…
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…
FDA issues draft guidance, requests public comments on communication of off-label information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policies regarding the communication of off-label information for drugs, biologics and devices, with the issuance of a draft guidance and the opening of a docket for public comments.
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…
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.
