On January 31, 2019, the Department of Health and Human Services (HHS) released a notice of proposed rulemaking (the Proposed Rule) as part of ongoing administration drug pricing reform efforts. The Proposed Rule would modify a regulatory provision that had
FCA Update
Exploring Recent Developments in False Claims Act Litigation, Enforcement and Compliance
The FCA Update blog, published by McDermott Will & Emery, focuses on legal developments related to the False Claims Act and enforcement issues impacting the healthcare industry. It covers topics such as healthcare compliance, government investigations, Medicare payment rules, Stark Law regulations, and litigation strategies. The blog also addresses regulatory guidance, policy changes, and practical implications for healthcare providers and organizations. It serves as a resource for updates on healthcare fraud and abuse laws, enforcement trends, and compliance best practices within the healthcare and life sciences sectors.
Latest from FCA Update - Page 3
Health Care Enforcement Quarterly Roundup | Q4 2018
This latest installment of the Health Care Enforcement Quarterly Roundup reflects on trends that persisted in 2018 and those emerging trends that will carry us into 2019 and beyond. Leading off with the US Department of Justice’s (DOJ) December announcement…
Updated Yates Memo Still Has Force In Civil Domain
In September 2015, Deputy Attorney General Sally Yates issued the Yates memo on individual accountability in the context of corporate investigations. It is no understatement to say that this memo created a near-cottage industry of articles and panels on the…
Process Improvements Not a Basis to Establish Scienter: District Court Grants Summary Judgment to Defendants
By Laura McLane
In a January 10, 2019 decision, the US District Court for the District of Arizona granted summary judgment to Defendants because Relators failed to raise a genuine issue of material fact on the issue of “knowledge” under the False Claims…
Health Care Dominates FCA Judgments and Settlements in 2018
By Tony Maida
On December 21, just before the government shutdown began, the Civil Division of the US Department of Justice (DOJ) announced its fiscal 2018 False Claims Act (FCA) statistics. According to DOJ, FCA judgments and settlements totaled over $2.8 billion for…
SCOTUS to Tackle Circuit Split on FCA Statute of Limitations After Cochise Consultancy, Inc. Decision
On November 16, 2018, the United States Supreme Court granted certiorari in United States ex rel. Hunt v. Cochise Consultancy, Inc., 887 F.3d 1081 (11th Cir. 2018). The question presented to the Court is “whether a relator in a False…
OIG Dusts off the Old Rule Book to Say No to Free Expensive Drugs to Hospitals
The Office of Inspector General, Department of Health and Human Services posted an unusual negative Advisory Opinion (AO 18-14) on a drug company’s proposal to provide free drugs to hospitals for use with pediatric patients suffering from a form of…
Practice Reminder: Research Misconduct can be a Source of False Claims Act Liability
The October issue of the journal Science features a series of short articles highlighting a database containing a list of more than 18,000 scientific papers and conference abstracts that have been retracted over the past several decades. An analysis of…
Best of McDermott’s 2018 Health Care Litigation, Compliance & Investigations Forum
At a time when health care organizations are facing greater financial and reputational costs than ever before, more than 150 health care industry leaders, legal and compliance executives, and investors gathered for McDermott’s Health Care Litigation, Compliance & Investigations Forum…
Eleventh Circuit Rules Qui Tam Relator Barred from Forfeiture Case
The False Claims Act (FCA) allows the government to pursue any “alternate remedy available” if the government chooses not to intervene in a qui tam action. See 31 U.S.C. § 3730(c)(5). However, if the government pursues an “alternate remedy,” the…