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HTMLRound 2: DOL Wins Right to Change Home Health Care Exemption
W. David Paxton; Gentry Locke Rakes & Moore, LLP;
Legal Alert/Article
August 28, 2015, previously published on August 2015
Until recently, the Department of Labor (DOL) interpreted the Fair Labor Standards Act (FLSA) to exempt from minimum wage and overtime pay those persons who provided “companionship services” (to the aged or infirm) [1] or were “live-in” domestic workers, [2] regardless who...

 

HTMLBack to School - HIPAA 101
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
August 27, 2015, previously published on August 27, 2015
After a summer that saw major data breaches at the Office of Personnel Management and UCLA Health System, this fall is a great time to take your organization back to school on HIPAA compliance and data security. Here are four items to add to your fall to-do list, no #2 pencils required.

 

Adobe PDFCourt Orders Divestiture of St. Luke’s Acquisition of a Physician Practice Group
Sandra Jarva Weiss; Norris McLaughlin & Marcus, P.A. A Professional Corporation;
Legal Alert/Article
August 26, 2015, previously published on August 2015
On February 10, 2015, the United States Court of Appeals for the Ninth Circuit ruled in favor of St. Alphonsus Medical Center and affirmed the district court’s order of divestiture by St. Luke’s Health System of an acquired physician practice group. The case arises out of the 2012...

 

HTMLState Pharmaceutical Pricing Disclosure Laws: Old Story, New Refrain
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
August 26, 2015, previously published on August 26, 2015
As a veteran of the AWP litigation era, I am struck by the recent state efforts to legislate transparency into pharmaceutical pricing. Multiple states have introduced bills that would require pharmaceutical manufacturers to produce information to justify the sales price for their drugs. But the...

 

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...

 

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.

 

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...

 

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...

 


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