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Documents on Government, Pharmaceuticals, Health Care
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|Five 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.;
October 20, 2016, previously published on October 14, 2016Our 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...
|Ontario Reintroduces Patients First Act, 2016 with Important Changes|
Meghan Lindo, Lydia Wakulowsky; Borden Ladner Gervais LLP;
October 20, 2016, previously published on October 13, 2016On 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.
|Ohio and Florida among States Favoring the Legalization of Medical Marijuana|
David D. Ebersole, David M. Kall, Susan Millradt McGlone; McDonald Hopkins LLC;
August 31, 2016, previously published on June 20, 2016Authorizing 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...
|New York DOH Proposes Updated Provider Contract Guidelines|
Bethany Hills; Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
July 20, 2016, previously published on June 17, 2016The 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.
|Introduction to Ontario’s Community Hubs Strategic Framework and Action Plan|
Brennan M. Carroll, Webnesh Haile, Nick G. Pasquino; Borden Ladner Gervais LLP;
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...
|Senate HELP Committee Convenes Third and Final Cures Markup|
Eli Greenspan; Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
April 27, 2016, previously published on April 6, 2016This 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...
|DOJ 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.;
December 29, 2015, previously published on December 8, 2015Late 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...
|The 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;
December 28, 2015, previously published on December 11, 2015On 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...
|Nicholas Nanovic Program Expert at Wills for Heroes|
Harold N. Iselin, Joshua L. Oppenheimer, Francis J. Serbaroli; Greenberg Traurig, LLP;
December 16, 2015, previously published on December 1, 2015On 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...
|Amarin and Off-Label Drug Use: What it Means for the Pharmaceutical Industry|
Stephen G. (Steve) Sozio; Jones Day;
September 14, 2015, previously published on September 2015The 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...