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HTMLAmarin and Off-Label Drug Use: What it Means for the Pharmaceutical Industry
Stephen G. Sozio; Jones Day;
Legal Alert/Article
September 14, 2015, previously published on September 2015
The U.S. District Court for the Southern District of New York recently issued a significant decision in Amarin Pharma, Inc. et al v. United States Food & Drug Administration. Amarin sought and won a preliminary injunction against the FDA to stop it from pursuing a misbranding case against the...


HTMLCON Laws, COPAs and the FTC: 7 Antitrust Points for the Healthcare Sector
Steven Levitsky, Lesli C. sposito; DLA Piper (Canada) LLP;
Legal Alert/Article
September 10, 2015, previously published on August 6, 2015
The Federal Trade Commission is on a roll in its attack on what it considers anti-competitive effects in the healthcare industry. And that roll has consistently involved challenging activity that once appeared to be protected by state laws.


HTMLU.S. District Court Issues Ruling on Preliminary Motion to Dismiss Interpreting 60-Day Overpayment Rule: Holds Identification Occurs when Providers Are "Put on Notice" of Potential Overpayment
Lindsey Lonergan, Rebekah N. Plowman; Jones Day;
Legal Alert/Article
September 10, 2015, previously published on September 2015
Compliance with the labyrinth of health care rules and regulations has always been a burdensome challenge for health care providers, and particularly for compliance officers who are frequently presented with potential overpayments that after months of investigation fail to reveal an actual...


HTMLHouse Conservatives Eye Medicare Reform
McDonald Hopkins LLC;
Legal Alert/Article
August 14, 2015, previously published on August 14, 2015
Republicans have long dreamed of reforming Medicare in a way that relies more on the private sector and less on the federal government. While the theory is popular among conservatives - particularly in think tank land - the dream has always been that - just a dream - as the political realities of a...


HTMLTrinity Homecare Settlement: Five False Claims Trends
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
July 16, 2015, previously published on July 15, 2015
New York State Attorney General Eric Schneiderman recently announced that his office had reached a $2.5 million settlement in a federal False Claims Act (FCA) case with Trinity HomeCare and its related entities. The case, filed as a qui tam action in federal district court in the Eastern District...


HTMLMaryland’s New False Claims Act: Is It Enough?
Steven A. Allen, Elliott D. Petty, Gregory S. Weiner; Pessin Katz Law, P.A.;
Legal Alert/Article
May 14, 2015, previously published on May 1, 2015
Maryland Senate bill 374 (cross filed with House bill 405) has made its way to Governor Larry Hogan’s desk for signature. Championed by Attorney General Brian Frosh, the bill expands Maryland’s False Claims Act from its current posture of only applying to false claims made against a...


HTMLEmployers Beware: Significant Penalties May Be Assessed for Reimbursement of Individual Health Insurance Policy Premiums
Mindi M. Johnson; Foster, Swift, Collins & Smith, P.C.;
Legal Alert/Article
March 19, 2015, previously published on December 18, 2014
Employers, including municipal employers, have historically struggled to develop a health insurance benefit program for their employees that provides quality benefits and is cost-effective. After the Health Insurance Marketplace opened for business, many employers recommended that their employees...


HTMLAdministration Touts Tax, Healthcare, and Education Proposals
Michael Caputo, Rebecca M. Kuhns, Aaron M. Ockerman, Todd A. Snitchler; McDonald Hopkins LLC;
Legal Alert/Article
March 18, 2015, previously published on February 13, 2015
The House Finance Committee continued hearings on Gov. Kasich's budget proposal this week. House Bill 64, a nearly 3,000 page bill, includes details on the governor’s spending proposal for fiscal years 2016 and 2017.


HTMLHealth Care Workers May Think Twice Before Becoming a Relator
Amy E. McCracken; Duane Morris LLP;
Legal Alert/Article
March 13, 2015, previously published on January 29, 2015
The Federal False Claims Act (and many similar state false claims acts) allow an individual-called a "relator"-to file a lawsuit on behalf of the United States Government. If successful, the relator stands to collect a portion of the amount collected. Since the False Claims Act provides...


HTMLFees and Costs Awarded to False Claims Act Defendant
Seth A. Goldberg; Duane Morris LLP;
Legal Alert/Article
March 13, 2015, previously published on January 9, 2015
A recent decision in the U.S. District Court for the Southern District of New York provides fair warning to qui tam relators who assert erroneous claims under the False Claims Act ("FCA") that they could be hit with legal fees and expenses pursuant to 31 U.S.C. § 3730, which permits...


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