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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The agency issued draft guidance on submitting patient preference information as part of PMA and HDE applications and de novo requests, as well as on incorporating the data in labeling, saying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.

 

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...

 

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...

 

HTMLFTC Says New York’s Medicaid Redesign Program May Promote Anticompetitive Behavior
Dionne C. Lomax, Stephen M. Weiner, Nili S. Yolin; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
Legal Alert/Article
May 14, 2015, previously published on May 4, 2015
In an April 22, 2015 letter to the New York State Department of Health (DOH), the Federal Trade Commission (FTC) cautioned that part of the State’s Medicaid reform program may sanction anticompetitive behavior. The FTC’s concern stems from the Certificate of Public Advantage (COPA)...

 

HTMLFTC Settles Radioactive Allegations Against Cardinal Health with a Near Record-Breaking Disgorgement Agreement
Helen J. Kim, Dionne C. Lomax, Bruce D. Sokler; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
Legal Alert/Article
May 6, 2015, previously published on April 21, 2015
In a 3-2 decision, as part of its aggressive antitrust enforcement in health care industries, the Federal Trade Commission (FTC or the Commission) announced that Cardinal Health, Inc. (Cardinal) agreed to pay $26.8 million to resolve the FTC’s allegations that Cardinal illegally monopolized...

 

HTMLFTC Flushes McWane in a Big Eleventh Circuit Exclusive Dealing Win
Helen J. Kim, Timothy J. Slattery, Bruce D. Sokler; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
Legal Alert/Article
May 6, 2015, previously published on April 22, 2015
The situations where exclusive dealing policies, explicit or tied to an aggressive discounting program, cross the line under the rule-of-reason remain far from clear. Because it involved appellate review of a Federal Trade Commission (“FTC” or the “Commission”) ruling...

 

HTMLHospital Wins First Round Against Largest Rival in Antitrust Suit Alleging Illegal Exclusive Dealing Agreements with Insurers
Robert G. Kidwell, Dionne C. Lomax, Farrah Short, Bruce D. Sokler; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
Legal Alert/Article
April 6, 2015, previously published on March 30, 2015
The waves of change affecting health care providers include reimbursement and funding developments, the impact of the Affordable Care Act, technological and medical advances, provider network design transformations imposed by payors — and antitrust. The Federal Trade Commission’s...

 

HTMLNinth Circuit Affirms FTC’s Challenge to Hospital-Physician Group Merger, While Rejecting Efficiencies and Health Care Quality Arguments
Robert G. Kidwell, Dionne C. Lomax, Farrah Short, Bruce D. Sokler; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
Legal Alert/Article
March 30, 2015, previously published on February 11, 2015
In a much anticipated appellate health care antitrust decision, the United States Court of Appeals for the Ninth Circuit upheld a district court’s finding that a consummated hospital-physician group merger violated Section 7 of the Clayton Act, despite the provider-defendants’ assertion...

 

HTMLDOJ Releases Electrifying New Guidance on Standard-Essential Patent Policy
Timothy J. Slattery, Bruce D. Sokler; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
Legal Alert/Article
March 30, 2015, previously published on February 10, 2015
The Department of Justice (the “Department” or “DOJ”) continued its multi-pronged defense of standards-setting organizations (SSOs) who adopt patent policies to prevent hold-up during licensing negotiations. Last week’s business review letter is just the latest of...

 


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