Health Law Advisor

The Food and Drug Administration (FDA) issued a draft guidance (Draft Guidance) on July 11, 2016 that allows some generic drug manufacturers holding an Abbreviated New Drug Application (ANDA) to update the label of the drug they manufacture with new safety information.  The Draft Guidance provides new clarifications and recommendations to generic drug manufacturers seeking to update a generic label after withdrawal by the name brand manufacturer of the reference listed drug (RLD) (a "Withdrawn RLD").  The Draft Guidance explains how a generic manufacturer may submit an updated ...

As requested by Congress as part of an appropriations bill signed into law late last year, this month, the Department of Health and Human Services (HHS) released a report highlighting its e-health and telemedicine efforts.  The report makes for interesting reading, and while there are no significant surprises in the report, it offers a clear snapshot of some of the agency’s thinking regarding virtual care.

The first thing I noted in the report is the agency’s view that “telehealth holds promise as a means of increasing access to care and improving health outcomes.”  This is ...

The U.S. Department of Health and Human Services, Office of Civil Rights ("OCR"), the agency tasked with enforcing the Health Insurance Portability and Accountability Act of 1996 ("HIPAA"), recently announced that it will redouble its efforts to investigate smaller breaches of Protected Health Information ("PHI") that affect fewer than five-hundred (500) individuals.

It has been widely known that OCR opens an investigation for every breach affecting more than 500 individuals; this announcement describes OCR's new initiative to investigate smaller breaches as well.  OCR ...

If your organization has missed an opportunity to participate in the voluntary Medicare Bundled Payments for Care Initiatives and/or the mandatory CJR program, CMS' Centers for Medicare and Medicaid Innovation has issued a proposed rule introducing three new mandatory Episode Payment Models (EPMs) and a Cardiac Rehabilitation incentive payment model intended to be tested with a broad scope of hospitals which may not have otherwise participated in innovative payment model testing.

In the proposed rule issued August 2, 2016, CMS introduced EPMs for Acute Myocardial infarction ...

Our colleague Marc A. Mandelman, a Member of the Firm at Epstein Becker Green, has a post on the Financial Services Employment Law blog that will be of interest to many of our readers in the health care industry: “8th Circuit Rules Parties to Corporate Transactions Cannot Contract Around the WARN Act Sale of Business Exception ”

Following is an excerpt:

In a rare case interpreting the Worker Adjustment and Retraining Notification (“WARN”) Act “sale of business” exception, the U.S. Court of Appeals for the 8th Circuit recently held in Day v. Celadon Trucking Servs ...

Our colleague Steven M. Swirsky, a Member of the Firm at Epstein Becker Green, has a post on the Management Memo blog that will be of interest to many of our readers in the health care industry: “Can Your Corporate Social Responsibility Policy Make You a Joint-Employer With Your Suppliers? The NLRB May Find That It Does”

Following is an excerpt:

The National Labor Relations Board (NLRB or Board), which continues to apply an ever expanding standard for determining whether a company that contracts with another business to supply contract labor or services in support of its ...

Our colleague Linda B. Celauro, Senior Counsel at Epstein Becker Green, has a post on the Financial Services Employment Law blog that will be of interest to many of our readers in the health care industry: “Seventh Circuit Panel Finds That Title VII Does Not Cover Sexual Orientation Bias.”

Following is an excerpt:

Bound by precedent, on July 28, 2016, a panel of the U.S. Court of Appeals for the Seventh Circuit held that sexual orientation discrimination is not sex discrimination under Title VII of the Civil Rights Act of 1964. The panel thereby affirmed the decision of the U.S ...

Where does the line fall between good faith and criminal intent? That was the question that a Massachusetts federal jury faced in July as it deliberated criminal charges against William Facteau and Patrick Fabian, ex-Acclarent executives, who were indicted on multiple charges of fraud and misbranding a medical device. Acclarent's device, the Relieva Stratus Microflow Spacer ("Stratus"), was cleared by the FDA for use as a spacer to maintain an opening in the sinus. Although the FDA expressly rejected Acclarant's request to expand the indicated use of the device to include delivery ...

Our colleagues James P. Flynn, Paul A. Gomez, Purvi B. Maniar and Yael Spiewak of Epstein Becker Green have published a blog post on the Trade Secrets & Noncompete Blog that will be of interest to our readers: "Assignment Lessons: 8th Circuit Finds Assigned Non-Competes Enforceable — Under Certain Facts."

Following is an excerpt:

The 8th Circuit's recent decision in Symphony Diagnostic Servs. No. 1 v. Greenbaum, No. 15-2294, __ F.3d __ (8th Cir. July 6, 2016), upheld the enforceability of non-compete and confidentiality agreements assigned by Ozark Mobile Imaging to ...

[caption id="attachment_2401" align="alignright" width="113"] Denise Dadika[/caption]

In a matter highlighting the importance of workplace violence prevention programs, Epic Health Services, a national home health care provider, was recently issued a citation and fine by the Occupational Safety and Health Administration (“OSHA”) for failing to protect its employees from the dangers of workplace violence. The fine and citation stemmed from a complaint by one of Epic’s nurses, who alleged she was sexually assaulted by a client while providing services in the ...