Legal Articles: Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

 







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HTMLIn the Wake of the Election, What’s Next for State Drug Pricing Initiatives?
Carrie A. Roll; Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
January 6, 2017, previously published on December 8, 2016
A Trump victory was not the only surprise on election night. California’s drug pricing initiative, which would have required state agencies to negotiate drug prices at least as low as those paid by the U.S. Department of Veterans Affairs, was defeated by a wide margin (46% to 54%). This...

 

HTMLForty-Five Days and Counting for Current HHS Leadership: Implications for Rulemaking
Ellyn Leslie Sternfield, Rodney Whitlock; Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
January 6, 2017, previously published on December 7, 2016
Before we all turn our full attention to the nominations of Representative Tom Price as Secretary of Health and Human Services, and policy consultant Seema Verma to lead CMS, we need to remember that there are still approximately 45 days remaining in the current administration. A perusal of the...

 

HTMLThe Future of the Medicare Part B Payment Demo under a Republican-held Congress
Theresa C. Carnegie, Eli Greenspan, Lauren Marie Moldawer, Rodney Whitlock; Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
January 6, 2017, previously published on November 29, 2016
There has been much controversy over the Medicare Part B payment demonstration proposed by the Center for Medicare and Medicaid Innovation (CMMI) in March 2016. As we await the release of the final rule, the fate of this demonstration will be in the hands of a Republican-held Congress and...

 

HTMLThe Medicare Part B Demo May be Dead, but Drug Pricing Concerns Still Linger
Lauren Marie Moldawer, Rodney Whitlock; Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
January 6, 2017, previously published on December 16, 2016
The Centers for Medicare & Medicaid Services (CMS) has withdrawn its controversial rule implementing the Medicare Part B payment demonstration. The agency stated that after consideration of the comments, it will not move forward with the demo.

 

HTMLThe Definition of Insanity? Wendy’s Shareholders File Derivative Action Based on 2015-16 Data Breach
Kevin M. McGinty; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
Legal Alert/Article
January 6, 2017, previously published on December 20, 2016
An old saw defines insanity as doing the same thing over and over again and expecting a different result. Wendy’s shareholders recently flouted that maxim by filing a derivative action this week against officers and directors of the fast-food chain seeking recovery on behalf of the...

 

HTMLSenate Passes 21st Century Cures Act, but Can It Cure an Ailing FDA?
Jordan T. Cohen, Bethany Hills; Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
January 6, 2017, previously published on December 9, 2016
On Wednesday, the U.S. Senate overwhelmingly passed the 21st Century Cures Act (the “Act”) by a vote of 94 to 5. Spearheaded by Michigan Representative Frank Upton, the bill now heads to President Obama who has promised to sign it. The Act is ambitious, and will impact a wide swath of...

 

HTMLChanges to the “But-For” Standard For Materiality at the U.S. Patent and Trademark Office?
Linyu Mitra, Christina Sperry; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
Legal Alert/Article
January 5, 2017, previously published on December 1, 2016
On October 28, 2016, the United States Patent and Trademark Office (PTO) issued a notice of proposed rulemaking in the Federal Register proposing revisions to the materiality standard for the duty to disclose information in patent applications and reexamination proceedings in light of Therasense,...

 

HTMLUSPTO Proposes Fee Increases for FY 2017
John Bunyan Forrest, Mark Pino; Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
January 5, 2017, previously published on December 21, 2016
The USPTO has published its notice of proposed rulemaking for the FY 2017 patent fee schedule in the Federal Register. The USPTO proposes fee increases to recover its estimated costs for patent operations and achieve its strategic goals of optimizing patent quality and timeliness and increasing...

 

HTMLCures Act Affirms Drug Companies’ Ability to Discuss Certain Information with Payors
Joanne S. Hawana; Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
January 5, 2017, previously published on December 22, 2016
Since congressional enactment and presidential signing of the Cures Act into law earlier this month, we have been blogging on discrete regulatory and clinical areas affected by its provisions. One small, but by no means insignificant, change is the Cures Act’s explicit recognition that drug...

 

HTML21st Century Cures Act Requires FDA to Expand the Role of Real World Evidence
Bethany Hills, Benjamin Zegarelli; Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
January 5, 2017, previously published on December 19, 2016
As we noted in our December 9th post, the 21st Century Cures Act (the “Cures Act”) requires FDA to develop a framework and guidance for evaluating real world evidence (“RWE”) in the context of drug regulation to support approvals of new indications for previously approved...

 


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