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Adobe PDFOIG Report Offers Glimpse into CMS Progress Towards MACRA Implementation
Jordan T. Cohen; Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
January 30, 2017, previously published on December 28, 2016
Last week, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services released a report analyzing CMS’ readiness to implement major parts of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). The report provides an inside look at the steps CMS is...

 

Adobe PDFHealth Care Enforcement Review And 2017 Outlook: Part 1
Joanne S. Hawana, Bethany J. Hills, Benjamin M. Zegarelli; Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
January 30, 2017, previously published on January 13, 2017
Over the past year, clear trends have emerged in the U.S. Food and Drug Administration's enforcement activities. Enforcement arising alleged violations of the Federal Food, Drug and Cosmetic Act (FFDCA) can take many forms, including FDA advisory actions such as warning letters, adverse...

 

HTMLUSCIS Unveils New Eligibility Standard for National Interest Waivers
Fragomen Del Rey Bernsen Loewy LLP;
Legal Alert/Article
January 30, 2017, previously published on December 28, 2016
In a precedent decision issued late Tuesday, the USCIS Administrative Appeals Office (AAO) announced a new analytical framework for determining whether a foreign national pursuing employment-based permanent residence in the EB-2 category is eligible for a discretionary waiver of the job offer and...

 

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...

 

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.

 

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...

 

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...

 

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...

 

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...

 

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...

 


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