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HTMLDOJ Issues Memo Directing Prosecutors to Focus on Individual Accountability
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
September 14, 2015, previously published on September 11, 2015
The U.S. Department of Justice (DOJ) issued a memorandum on Wednesday from Deputy Attorney General Sally Quillian Yates that reaffirms the Government’s commitment to prosecuting individuals and formally instructs prosecutors to focus on individual accountability when dealing with corporate...


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...


HTMLFDA Updates List of Tropical Diseases Eligible for Award of Priority Review Voucher
Edgar J. Asebey, Maureen Bennett, Christian B. Fulda, Colleen Heisey, Cristiana Spontoni; Jones Day;
Legal Alert/Article
September 4, 2015, previously published on September 2015
In a final order issued August 20, 2015, FDA updated the list of tropical disease products eligible to receive a priority review voucher ("PRV"), an incentive to encourage the development of new drugs for the prevention or treatment of certain diseases by providing priority review of a...


HTMLPersonal Injury Medical Malpractice Caps Held Unconstitutional
Julie A. Tyk; GrayRobinson, P.A.;
Legal Alert/Article
July 22, 2015, previously published on July 22, 2015
On July 1, 2015, the Fourth District Court of Appeals (Fourth DCA) issued a major decision affecting medical malpractice cases in Florida. In the case North Broward Hospital District v. Kalitan, the court held that the caps on non-economic damages in personal injury medical malpractice cases were...


HTMLXarelto Science Day Set By Court
Robinson Waters ODorisio P.C.;
Legal Alert/Article
July 3, 2015, previously published on June 19, 2015
Hundreds of Xarelto lawsuits filed in federal court have been transferred for pretrial procedures to the U.S. District Court in the Eastern District of Louisiana. These Xarelto lawsuits are now part of a Multi-District Litigation (MDL) established to handle the cases more efficiently by having one...


HTMLOIG Cautions Physicians to Consider Compensation Arrangements Carefully
Michele R. Goodman, Gerald M. Griffith, Rebekah N. Plowman; Jones Day;
Legal Alert/Article
June 23, 2015, previously published on June 2015
The Department of Health and Human Services, Office of Inspector General ("OIG") recently released a fraud alert cautioning physicians who enter into medical directorships and other compensation arrangements, recommending that they consider whether the terms and conditions of such...


HTMLFingerprint-Based Background Checks Begin August 1st for Medicaid Providers
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
June 16, 2015, previously published on June 4, 2015
On June 1st, the Centers for Medicare and Medicaid Services (CMS) released a State Medicaid Director Letter (SMD Letter) providing guidance to states on the criminal background check and fingerprinting requirements for Medicaid provider enrollment. This sub-regulatory guidance starts a 60 day clock...


HTMLTightening the Belt: The Shrinking Scope of Harmless Error
Laura J. Persun; Marshall Dennehey Warner Coleman & Goggin, P.C.;
Legal Alert/Article
June 11, 2015, previously published on June 1, 2015
In late January 2015, the Pennsylvania Superior Court issued an opinion that justified its decision to overturn the trial court. It highlighted testimony in which the minor plaintiff’s expert witness and the defendants’ attorneys referenced the availability of collateral sources. Even...


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