CMS FDA and CMS Call for Nationwide Changes Thomas Sullivan Aug 31, 2016 0 Recently, CMS Administrator Andy Slavitt and FDA Commissioner Dr. Robert Califf wrote a joint letter to Gary Beatty, Chair of the…
Uncategorized Misleading Survival Data Leads to FCA Liability in Recent Genentech Case Thomas Sullivan Aug 31, 2016 0 The DOJ and FDA are starting to back off prosecuting cases involving just off-label claims, after making several unsuccessful…
Uncategorized Novartis Execs Indicted in South Korea Thomas Sullivan Aug 30, 2016 0 Six executives from the South Korean unit of Novartis have been indicted by prosecutors for paying rebates to doctors in return…
Uncategorized Railroad Retirement Board (RRB) First to Double-Down on DOJ’s Civil… Thomas Sullivan Aug 30, 2016 0 In early July of this year, the Railroad Retirement Board (RRB) became the first federal agency to implement the mandatory…
HHS HRSA Releases Proposed Rule on 340B ADR Program Thomas Sullivan Aug 29, 2016 0 On August 12, 2016, the Health Resources and Services Administration (HRSA) published a proposed rule: “340B Drug Pricing Program;…
Uncategorized A Mixed Bag – Implied Certification in False Claim Act Cases after… Thomas Sullivan Aug 29, 2016 0 The United States Supreme Court, in recent decision in Universal Health Services, Inc. v. United States ex rel. Escobar…
CMS Rocky Start to CMS ACO Program Thomas Sullivan Aug 26, 2016 0 Three of the 21 participants in CMS’ newest accountable care organizations program, the Next Generation ACOs, have withdrawn since…
Uncategorized Weighing in on the Recent Acquittals – Former HHS Inspector General… Thomas Sullivan Aug 26, 2016 0 Richard Kusserow served as Health and Human Services Inspector General from 1981 to 1992. In this article, he discusses the…
Open Payments Deep Dive Analysis of 2017 Proposed Physician Fee Schedule Thomas Sullivan Aug 25, 2016 0 As we previously covered, in July CMS released its annual proposed updates to the Physician Fee Schedule. There are a number of…
Uncategorized Federal Circuit Interprets BPCIA Provision on Notice of Commercial… Thomas Sullivan Aug 24, 2016 0 In early July 2016, a three-judge panel of the Federal Circuit Court of Appeals issued a unanimous decision in Amgen v. Apotex…