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HTMLState Action May Block Big Savings on Biosimilars
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
June 16, 2015, previously published on June 9, 2015
The recent influx of state legislation on biologics and biosimilars may actually hinder rather than advance the use of biosimilars. Our colleagues Theresa Carnegie, Joanne Hawana, and Ellyn Sternfield discuss this issue in a recent article published in BNA’s Medicare Report. The article...

 

HTMLHawaii Bill Mandates 100% Renewable Energy by 2045, but Obstacles Remain
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
June 16, 2015, previously published on June 1, 2015
In an ambitious and unprecedented move, Hawaii is aiming to increase its current renewable energy output of 21% to a 100% quota by 2045. The state, which carries some of the U.S.’s highest electricity costs, is riding the momentum of decreasing renewable energy prices. Legislators believe...

 

HTMLFDA Issues Guidance on Leveraging Adult Clinical Data to Support Marketing Approval and Labeling of Pediatric Devices
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
June 16, 2015, previously published on May 2015
The regulator is looking to remedy a lack of available scientific evidence to support pediatric device indications in PMA applications and HDEs by encouraging the extrapolation from existing clinical data, hoping the approach will streamline the requirements for establishing a pediatric intended...

 

HTMLA Split FTC Accepts Fix-It-First Divestiture Remedy for Cigarette Merger
Farrah Short, Bruce D. Sokler; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
Legal Alert/Article
June 16, 2015, previously published on May 28, 2015
The Federal Trade Commission (“FTC”) accepted on Tuesday from Reynolds American Inc. (“Reynolds”) and Lorillard Inc. (“Lorillard”), subject to final approval, a Consent Order settling the agency’s significant competitive concerns with Reynolds’s...

 

HTMLInjunction Blocks Implementation of Texas Telemedicine Regulations
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
June 16, 2015, previously published on June 4, 2015
Late last week, Texas telemedicine practitioners received a temporary reprieve from a new regulation issued by the Texas Medical Board (the “Board”) when a Texas federal court prohibited implementation of the new rule that would have prevented prescribing via telemedicine. The...

 

HTMLFDA to Consider Patient Preference Data During Decision-Making for Devices under PMA, HDE or De Novo Review
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
June 16, 2015, previously published on May 2015
The agency issued draft guidance on submitting patient preference information as part of PMA and HDE applications and de novo requests, as well as on incorporating the data in labeling, saying patient perspectives can be important to take into consideration when making benefit-risk determinations.

 

HTMLProposed CMS Rule Aims to Modernize Managed Care for Medicaid and CHIP Enrollees
Tricia A. Asaro, Amanda R. Ledford; Greenberg Traurig, LLP;
Legal Alert/Article
June 16, 2015, previously published on June 1, 2015
On May 26, 2015, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule (the “Proposed Rule”) that would revise the Medicaid managed care regulations for the first time since 2002. Since the regulations were last updated, managed care plans have grown to cover a...

 

HTMLVP Biden’s Son Passes Away of Brain Cancer
McDonald Hopkins LLC;
Legal Alert/Article
June 15, 2015, previously published on June 5, 2015
Over the weekend, the family of Beau Biden (D-Del.), son of Vice President Joe Biden, announced that he had died after a battle with brain cancer. Biden, who was 46, served as the Attorney General of Delaware from 2007 until early this year.

 

HTMLFinal Rule Will Allow More Physicians to Participate in Multiple ACOs
Rick L. Hindmand; McDonald Hopkins LLC;
Legal Alert/Article
June 15, 2015, previously published on June 9, 2015
On June 4, 2015, the Centers for Medicare & Medicaid Services (CMS) issued a final rule that revises the Medicare Shared Savings Program (MSSP) regulations relating to accountable care organizations (ACOs). The final rule includes changes that provide increased flexibility for physicians in...

 

HTMLAllegheny Court Refuses to Recognize Negligence Claim for Data Breach
Mark L. Mattioli, Mary Kate McGrath; Marshall Dennehey Warner Coleman & Goggin, P.C.;
Legal Alert/Article
June 12, 2015, previously published on June 9, 2015
On May 28, 2015, the Honorable Stanton Wettick sustained preliminary objections in Dittman v. UPMC, dismissing all counts in a class action matter brought on behalf of 62,000 employees of the University of Pittsburgh Medical Center (UPMC). The plaintiffs alleged that UPMC failed to enact...

 


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