Health Law Advisor

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 ...

On July 7, 2016, the Centers for Medicare and Medicaid Services ("CMS") imposed several administrative penalties on Theranos, a clinical laboratory company that proposed to revolutionize the clinical laboratory business by performing multiple blood tests using a few drops of blood drawn from a finger rather than from a traditional blood draw that relies on needles and tubes. However, after inspecting the laboratory, CMS concluded that the company failed to comply with federal law and regulations governing clinical laboratories and it posed an immediate jeopardy to patient ...

Entities that provide goods and services to the federal government, including health care providers and life sciences companies, should take note of the new civil monetary penalty amounts applicable to False Claims Act ("FCA") violations. After much anticipation, the U.S. Department of Justice ("DOJ") issued an interim final rule on June 30, 2016 confirming speculation that the penalty amounts will increase twofold.

The new minimum per-claim penalty amount will increase from $5,500 to $10,781, and the maximum per-claim penalty amount will increase from $11,000 to $21,563. The ...

[caption id="attachment_2451" align="alignright" width="113"] Maxine Neuhauser[/caption]

In an unpublished decision issued July 22, 2016, the New Jersey Appellate Division ruled that an overnight residential counselor for developmentally disabled adults was properly disqualified from unemployment because of “severe misconduct” after having been found sleeping on the job. In affirming the Division of Unemployment’s denial of benefits, the court noted that this was the employee’s second documented violation “of his employer’s most basic rule: stay ...

[caption id="attachment_2394" align="alignright" width="113"] Nathaniel M. Glasser[/caption]

On July 18, 2016, the final rule implementing Section 1557 of the Affordable Care Act (“ACA”) went into effect.   Section 1557 prohibits health care providers and other covered entities from refusing to treat individuals or otherwise discriminating on the basis of race, color, national origin, sex, age, or disability in any health program or activity that receives federal financial assistance or is administered by an executive agency.

While the rule does not apply to ...

Our colleagues Adam C. Abrahms and Steven M. Swirsky, attorneys at Epstein Becker Green, have a post on the Management Memo blog that will be of interest to many of our readers in the health care industry: “NLRB Drops Other Shoe on Temporary/Contract Employee Relationships: Ruling Will Require Bargaining In Combined Units Including Employees of Multiple Employers – Greatly Multiplies Impact of BFI Expanded Joint Employer Test.”

Following is an excerpt:

The National Labor Relations Board (“NLRB” or “Board”) announced in its 3-1 decision in Miller & Anderson, 364 ...

On Monday, June 27, 2016, the U.S. Supreme Court declined to review a D.C. Circuit Court of Appeals decision upholding the new U.S. Department of Labor’s (DOL) requirement that home care providers pay the federal minimum wage and overtime to home care workers.  As we previously discussed, on August 21, 2015, the D.C. Circuit in Home Care Association of America v. Weil affirmed the validity of the Home Care Final Rule, which eliminated a long-existing prior regulation and barred third-party employers from claiming minimum wage and overtime exemptions for home care workers.

The U.S ...

The District of Columbia Office of Human Rights recently partnered with the National LGBTQ Task Force to publish a resource guide, “Valuing Transgender Applicants & Employees: A Best Practices Guide for Employers” (the “Guide”), designed to support employers in creating workplace and hiring policies that prevent discrimination against transgender and gender-nonconforming individuals. The guide is meant to lay the framework for building a culture of inclusion in the workplace that goes beyond legal obligations.

The suggested best practices include ensuring ...