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HTMLThe Future of the ACA Week 4: The Ryan Plan, “A Better Way”
Alden J. Bianchi, Edward Lenz; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
Legal Alert/Article
January 27, 2017, previously published on December 29, 2016
The recent Republican election victories appear to ensure that the Affordable Care Act’s (ACA) days are numbered. But with nearly a fifth of the U.S. economy, and the health care coverage for some tens of millions of U.S. citizens, at stake, the law will not simply be repealed. Somethingwill...

 

Adobe PDFHealthcare Held Hostage
Laura E. Jehl; Sheppard, Mullin, Richter & Hampton LLP;
Legal Alert/Article
January 27, 2017, previously published on December 2016
It’s happened again. On November 2, an unspecified “major” cyberincident forced three National Health Service (NHS) hospitals in the UK to shut down all planned operations and divert critically ill patients to other facilities for three days until their electronic systems could be...

 

HTMLOCR Newsletter Emphasizes Audit Controls
Rick L. Hindmand; McDonald Hopkins LLC;
White Paper
January 27, 2017, previously published on January 13, 2017
The Department of Health and Human Services Office for Civil Rights (OCR) issued its January 2017 Cyber Awareness Newsletter today advising HIPAA covered entities and business associates to use proper audit control tools and also secure and regularly review audit trails.

 

HTMLHealth Care Enforcement Review and 2017 Outlook: FDA’s Wide-Ranging Activities
Joanne S. Hawana, Bethany Hills, Benjamin Zegarelli; Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
January 27, 2017, previously published on January 4, 2017
Over the past year, clear trends have emerged in FDA’s enforcement activities. Enforcement arising from alleged violations of the Federal Food, Drug, and Cosmetic Act (FFDCA) can take many forms, including FDA advisory actions such as warning letters, adverse inspectional observations that...

 

HTMLHealth Care Enforcement Review and 2017 Outlook: Yates Memo in Action
Eoin P. Beirne; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
Legal Alert/Article
January 27, 2017, previously published on January 3, 2017
Happy New Year! As we kick off 2017, our Health Care Enforcement Defense team brings you its annual review of key government policies, regulations, and enforcement actions in 2016, and the impact these trends are expected to have on enforcement in the year ahead. We start with a look at the Yates...

 

HTMLGrassley Continues To Press CMS on Medicaid Drug Rebate Classifications: What Will Be the Fallout?
Ellyn Leslie Sternfield, Rodney Whitlock; Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
January 27, 2017, previously published on January 12, 2017
Back in early October, we were all transfixed by the announced Mylan settlement with the U.S. Department of Justice (DOJ) over Mylan’s alleged underpayments of Medicaid Drug Rebates for the EpiPen. Although Mylan indicated that its $465 million settlement resolved all potential liability to...

 

HTMLThe Future of the Affordable Care Act (Week 2): A Framework for Handicapping Proposals to Replace the ACA
Alden J. Bianchi; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
Legal Alert/Article
January 26, 2017, previously published on December 6, 2016
The Affordable Care Act made fundamental and important changes to the way the United States finances health care. The law did not represent a radical departure from prior law or policy, however. The ACA instead worked within, rather than disrupting, existing market-based, legal and regulatory...

 

HTMLThe Future of the ACA Week 5: The Rep. Tom Price Plan(s)
Alden J. Bianchi, Edward Lenz; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
Legal Alert/Article
January 26, 2017, previously published on January 11, 2017
This week continues our survey of key Republican proposals to “repeal and replace” the Affordable Care Act (ACA). In the past two weeks, we have reviewed the Trump/Pence transition plan, entitled “Healthcare Reform to Make America Great Again,” and House Speaker Paul...

 

HTMLHealth Care Enforcement Review & 2017 Outlook: Important Case Law Developments
Laurence J. Freedman, Samantha P. Kingsbury, Karen S. Lovitch; Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
January 25, 2017, previously published on January 5, 2017
In 2016, courts around the country heard cases involving a variety of False Claims Act (FCA) and other enforcement-related matters, and going forward these case law developments are expected to have an impact on both the scope of FCA liability and the means by which FCA liability can be proven at...

 

HTMLTrial Court Grants Summary Judgment Pursuant to New Jersey Medical Care Access and Responsibility and Patients First Act.
Dylan T. Hastings; Marshall Dennehey Warner Coleman & Goggin, P.C.;
Legal Alert/Article
January 24, 2017, previously published on January 3, 2017
The defendant, a family practice physician, performed a phlebectomy on the plaintiff, which she claimed caused her permanent injuries. At the ensuing Ferreira conference, the defendant took the position that he was acting as a “family medicine specialist” when he performed the...

 


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