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HTMLOff-Label Marketing and the False Claims Act
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
August 24, 2015, previously published on August 21, 2015
In a post published earlier this week this week our colleagues Brian Dunphy and Joanne Hawana examined key issues in the recent Amarin decision from the Southern District Court of the New York. The August 7th ruling provided Amarin Pharma, Inc. with a preliminary injunction that blocks FDA from...

 

HTMLThe Affordable Care Act’s Reporting Requirements for Carriers and Employers (Part 5 of 24): Reporting of Health Reimbursement Arrangements under Code § 6055 (Spoiler Alert: You Are Not Going to Like This One)
Alden J. Bianchi; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
Legal Alert/Article
August 19, 2015, previously published on August 19, 2015
As we reported last week, the IRS recently issued draft 2015 Instructions for Forms 1094-C and 1095-C. These instructions are of interest to applicable large employers who must report their compliance with the Affordable Care Act’s (ACA) rules governing employer shared responsibility. At the...

 

HTMLPharmaceutical Manufacturer's Preemptive Suit Secures Preliminary First Amendment Protection for Script to Promote Off-Label Use
Aaron Buchman, Bret A. Campbell, Adam S. Lurie, Brian T. McGovern, Martin L. Seidel; Cadwalader, Wickersham & Taft LLP;
Legal Alert/Article
August 19, 2015, previously published on August 17, 2015
On August 7, 2015, the U.S. District Court for the Southern District of New York invoked the First Amendment, granting Amarin Pharma, Inc. (Amarin) preliminary protection against federal criminal prosecution for misbranding and allowing Amarin to promote its drug, Vascepa, for off-label use through...

 

HTMLPersonalized Medicine and Alternative Payment Models
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
August 19, 2015, previously published on August 19, 2015
Earlier this month, my colleague Andy Shin at ML Strategies co-authored an article in the American Journal of Managed Care for a special issue of Evidence-Based Oncology, focusing on personalized medicine.

 

HTMLThree Bytes for End of Summer
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
August 18, 2015, previously published on August 17, 2015
If you are subject to HIPAA and the oversight of the Department of Health and Human Services (HHS), schadenfreude will probably best describe your reaction.

 

HTMLFirst Amendment Protects Truthful Off-Label Speech by Drug Manufacturers
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
August 17, 2015, previously published on August 17, 2015
Pharmaceutical manufacturers have likely taken note of Amarin Pharma Inc.’s recent success in a pre-enforcement legal challenge against the Food and Drug Administration (FDA or the Agency). On August 7, 2015, Amarin obtained a preliminary injunction that prevents the Agency from bringing...

 

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...

 

HTMLFlorida House Health and Human Services Committee Chair Jason Brodeur Discusses Ambulatory Surgical Center Data, Legislation at Governor's Commission on Healthcare and Hospital Funding Meeting in Tallahassee
G. Donovan Brown; Colodny Fass, P.A.;
Legal Alert/Article
August 14, 2015, previously published on August 13, 2015
State Representative Jason Brodeur was among the presenters at Florida Governor Rick Scott's Commission on Healthcare and Hospital Funding ("Commission") meeting in Tallahassee yesterday, August 12, 2015. The discussion focused on current rules and regulations relating to Florida's...

 

HTMLExtended Due Dates
Thomas N. Lawson; Loeb & Loeb LLP;
Legal Alert/Article
August 14, 2015, previously published on August 2015
The Surface Transportation and Veterans Health Care Choice Improvement Act generally provides both S and C corporations an automatic six-month extension to file their returns effective for taxable years beginning after Dec. 31, 2015. Calendar-year C corporations will be allowed only an automatic...

 

HTMLThe Shrinking Scope of the Peer Review Protection Act
Brett C. Shear; Marshall Dennehey Warner Coleman & Goggin, P.C.;
Legal Alert/Article
August 14, 2015, previously published on September 1, 2015
The Peer Review Protection Act is an important Pennsylvania statute that aims to provide an incentive for health care providers, practice groups and hospitals to police themselves by seeking peer review when something goes wrong. The statute provides that the proceedings and records of a review...

 


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