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HTMLOCR to Step Up Investigations of Small HIPAA Breaches
James J. Giszczak, Rick L. Hindmand, Dominic A. Paluzzi; McDonald Hopkins LLC;
Legal Alert/Article
September 14, 2016, previously published on August 19, 2016
Yesterday, the U.S. Department of Health and Human Services Office for Civil Rights (OCR) announced its new initiative to investigate breaches of protected health information (PHI) affecting fewer than 500 individuals.

 

HTMLWhen Patient Care Needs and Employee FMLA Demands Conflict
Liz S. Washko; Ogletree, Deakins, Nash, Smoak & Stewart, P.C.;
Legal Alert/Article
September 14, 2016, previously published on September 7, 2016
A healthcare employer’s primary mission is to provide appropriate medical care and treatment to patients. In order to provide such care, healthcare companies rely on the steady and committed presence of competent, licensed professionals who are ready, willing, and able to perform the tasks...

 

HTMLHospital and Fixed Indemnity Policies; Excepted Benefits; Supplemental Coverage under Recently Proposed Treasury Regulations; and Central United Life v. Burwell
Alden J. Bianchi; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
Legal Alert/Article
September 12, 2016, previously published on August 26, 2016
We reported in a recent post on proposed regulations dealing with, among other things, the treatment of hospital indemnity or other fixed indemnity insurance products in the group market. This post takes a closer look at the future of these products under the proposed rules and in light of a recent...

 

HTMLMassachusetts Determination of Need Regulation Overhaul
M. Daria Niewenhous; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
Legal Alert/Article
September 12, 2016, previously published on August 24, 2016
The Massachusetts Department of Public Health (DPH) Determination of Need (DoN) Program has unveiled proposed regulations that constitute an ambitious and, perhaps, long overdue overhaul of the DoN Program regulations. Attendees at the August 23, 2016 Public Health Council (PHC) meeting were...

 

HTMLFDA Announces Dates for Long-Awaited Public Hearing on Its Regulation of Off-Label Communications
Joanne S. Hawana, Joseph D. Lipchitz; Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
September 12, 2016, previously published on September 1, 2016
On Wednesday, FDA announced that it will hold a two-day public hearing on November 9th and 10th to obtain input from a broad cross-section of the health care industry, including pharmaceutical and medical device companies, doctors, patients, research institutions, health care organizations, and...

 

HTMLNew Safe Harbors for Management Contracts of Tax-Exempt Financed Facilities
Sheila Kles; Shumaker, Loop & Kendrick, LLP;
Legal Alert/Article
September 12, 2016, previously published on August 24, 2016
The Internal Revenue Service on August 22, 2016 released Revenue Procedure 2016-44 which revises the safe harbor guidelines for management contracts of service providers for tax-exempt financed facilities, under which the contract will not result in private business use of the managed property. The...

 

HTMLOCR Blitzkrieg: Wider Investigation of Smaller Breaches
Kelly A. Leahy; Shumaker, Loop & Kendrick, LLP;
Legal Alert/Article
September 12, 2016, previously published on August 22, 2016
On the heels of its first business associate settlement with a business associate and a hat trick of multi-million dollar settlements with covered entities involving electronic Protected Health Information (“PHI”), on August 18, 2016 the Office for Civil Rights (“OCR”)...

 

HTMLNew Private Use Safe Harbors for Tax-Exempt Hospitals and Other Qualified Users: New Flexibility, New Restrictions, and Open Questions
Gerald M. (Gerry) Griffith, Catherine E. (Cathy) Livingston; Jones Day;
Legal Alert/Article
September 12, 2016, previously published on September 2016
New safe harbor guidelines released by the IRS on August 22, 2016 (Rev. Proc. 2016-44) are likely to have a significant impact on a variety of management and service contracts entered into by tax-exempt hospitals financed with tax-exempt bonds. The new safe harbor guidance provides significant...

 

HTMLBiosimilar FDA Approvals on the Horizon As More States Enact Substitution Laws
Joanne S. Hawana, Sarah Beth Smith; Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
September 12, 2016, previously published on August 30, 2016
UPDATE (August 31, 2016): Shortly after we published this blog post, FDA approved Sandoz’s biosimilar to Amgen’s Enbrel (etanercept), called Erelzi (etanercept-szzs). Erelzi becomes the third biosimilar to receive FDA approval (the second for Novartis subsidiary Sandoz) and is indicated...

 

HTMLNo Resuscitation of Hospital’s Exclusive Dealing Antitrust Suit against Competing Hospitals and Physicians
Farrah C. Short, Bruce D. Sokler; Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
September 11, 2016, previously published on August 23, 2016
The Third Circuit reminds, “[i]n antitrust suits, definitions matter.” Last week, in applying that maxim, the court affirmed a lower court’s dismissal of a suit filed by a hospital against a competing hospital and physician group, in which the plaintiff hospital alleged that...

 


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