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HTMLFive Things to Know About the Mylan EpiPen “Settlement” - What It Is and What It Isn’t
Ellyn Leslie Sternfield, Rodney Whitlock; Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
October 20, 2016, previously published on October 14, 2016
Our eyebrows were raised by Mylan’s October 7, 2016 announcement that it had reached a $465 million “settlement” with the United States Department of Justice (DOJ) and “other government agencies” over its Medicaid Drug Rebate obligations for EpiPen. The timing of the...


HTMLOntario Reintroduces Patients First Act, 2016 with Important Changes
Meghan Lindo, Lydia Wakulowsky; Borden Ladner Gervais LLP;
Legal Alert/Article
October 20, 2016, previously published on October 13, 2016
On October 6, 2016, the Ontario Legislature reintroduced the Patients First Act, 2016 as Bill 41. Bill 41 is very similar to its predecessor, Bill 210, which was introduced in June 2016, but makes some important changes to the previous bill.


HTMLOhio and Florida among States Favoring the Legalization of Medical Marijuana
David D. Ebersole, David M. Kall, Susan Millradt McGlone; McDonald Hopkins LLC;
Legal Alert/Article
August 31, 2016, previously published on June 20, 2016
Authorizing medical marijuana in the Buckeye State, Gov. John Kasich signed House Bill 523 into law on June 8, 2016. The Marijuana Policy Project, an organization with the sole focus of ending marijuana prohibition, applauded the legislation, pleased that “ill patients in Ohio will have...


HTMLNew York DOH Proposes Updated Provider Contract Guidelines
Bethany Hills; Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
July 20, 2016, previously published on June 17, 2016
The NYS Department of Health (DOH) has proposed new guidelines for the provider contract submission and review process to reflect Value Based Payment arrangements pursuant to the New York State Value Based Payment (VBP) Roadmap (Roadmap) and the Regulatory Impact Subcommittee.


HTMLIntroduction to Ontario’s Community Hubs Strategic Framework and Action Plan
Brennan M. Carroll, Webnesh Haile, Nick G. Pasquino; Borden Ladner Gervais LLP;
Legal Alert/Article
May 26, 2016, previously published on April 22, 2016
The concept of multiple organizations sharing space and resources is not a new one. Since 2015, however, the Ontario government has expressed a new dedication to fostering these collaborations as a key element of the cost-efficient and effective delivery of services to Ontario's diverse...


HTMLSenate HELP Committee Convenes Third and Final Cures Markup
Eli Greenspan; Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
April 27, 2016, previously published on April 6, 2016
This morning the Senate Committee on Health, Education, Labor, and Pensions (HELP) will hold its third and final markup for its biomedical innovations package. This package is a compliment to the House-passed 21st Century Cures Act, which the House passed in July of 2015. The previous two hearings...


HTMLDOJ Recovers $3.5 Billion in False Claims Act Cases in FY2015 and Pays Record Amount to Qui Tam Relators
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
December 29, 2015, previously published on December 8, 2015
Late last week, the Department of Justice (DOJ) announced that in FY2015 it obtained more than $3.5 billion in settlements and judgments from civil cases involving allegations of false claims against the government. Once again, health care fraud recoveries led the pack, driven by qui tam...


HTMLThe End of the Implied Certification Theory?: The U.S. Supreme Court Grants Certiorari in Case That Could Substantially Limit the False Claims Act
Jonathan Bailyn, Keith M. Gerver, Adam S. Lurie, Brian T. McGovern, Anne M. Tompkins; Cadwalader, Wickersham & Taft LLP;
Legal Alert/Article
December 28, 2015, previously published on December 11, 2015
On December 4, 2015, the United States Supreme Court granted certiorari in Universal Health Services, Inc. v. United States ex rel. Escobar. In Universal Health Services, Inc., the Supreme Court will decide the legal validity of the “implied certification” theory of False Claims Act...


HTMLNicholas Nanovic Program Expert at Wills for Heroes
Harold N. Iselin, Joshua L. Oppenheimer, Francis J. Serbaroli; Greenberg Traurig, LLP;
Legal Alert/Article
December 16, 2015, previously published on December 1, 2015
On Nov. 13, 2015, the Albany County Supreme Court upheld New York Governor Cuomo’s Executive Order regarding executive compensation and administrative expenses of certain service providers (EO 38), as well as several aspects of the EO 38 regulations promulgated by the New York State...


HTMLAmarin and Off-Label Drug Use: What it Means for the Pharmaceutical Industry
Stephen G. (Steve) 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...


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