Health Law Advisor

In early October, FDA held a public workshop to discuss the challenges of regulating medical devices made through additive manufacturing (also known as 3-D printing). Additive manufacturing gives designers the ability to build devices directly from 3-D images, like patient CT or MRI scans. As the push toward personalized medicine continues, 3-D printed devices hold incredible potential for advancing the ball. While additive manufacturing isn't completely mainstream yet, FDA and industry stakeholders expect to see major growth in this field in coming years. Experts project ...

Epstein Becker Green is pleased to announce that Valerie Butera, an accomplished Occupational Safety & Health (OSHA) lawyer, has joined as a Member of the Firm based in the firm's Washington, D.C., office.  Valerie is OSHA 30 certified and has substantial training and experience in process safety management (PSM). Valerie represents clients from numerous industries, including health care and life sciences and focuses on OSHA and other workplace safety and health issues.   For more information, click here.

The Ebola virus disease ("Ebola") has become a worldwide threat, which, among many other effects, has forced employers to think about how to protect their employees. Employers also must consider how Ebola might impact employment policies and procedures, including, but not limited to, those addressing attendance, leaves of absence, discipline, and medical testing.

Employers are generally tasked with maintaining safe and productive workplaces for their employees, and the Ebola scare has brought many challenges in this regard. In particular, employers' desire to maintain safe ...

In response to the ongoing threat of the Ebola Virus Disease ("EVD" or "Ebola") and the increased risk of individuals traveling from the affected countries to the United States, The Joint Commission recently launched an Ebola Preparedness Resources portal on its website.  The portal contains information addressing various safety actions for health care providers to consider, such as ensuring that all staff and clinicians who may come in contact with Ebola patients are educated and trained on Ebola guidance, re-evaluating infection control plans to ensure proper guidelines ...

The Office of the Inspector General ("OIG") of the U.S. Department of Health and Human Services ("HHS") has extended the deadline, to December 28, 2014, for comments to the non-binding criteria used by OIG in assessing whether to impose a permissive exclusion, which were first published in 1997.  See our previous blog post for information on the OIG's initial solicitation for comments.

Please reach out to George Breen, Jonah Retzinger, or Marshall E. Jackson, Jr., for assistance with the preparation and submission of comments.

Although FDA appropriately identified the need for guidance on the Effect of Section 585 of the FD&C Act on Drug Product Tracing, Wholesale Drug Distributor and Third-Party Logistics Provider Licensing Standards and Requirements; the Draft Guidance issued by FDA this month does not ask the right questions.

In November 2013, Congress enacted the Drug Supply Chain Security Act ("DSCSA") with the intent of establishing a "Uniform National Policy" for wholesale distributor and third party logistics provider ("3PL") licensure.  Congress hoped to achieve this goal by adding Section ...

Epstein Becker Green and EBG Advisors, as part of the Thought Leaders in Population Health Speaker Series, will host a complimentary webinar titled The Impact of Value-Based Purchasing and Other Employee Initiatives on Population Health.  This session will discuss several approaches for population health managers to reduce costs and improve health care.

The webinar, scheduled for November 20, 2014, at 12:00 p.m. ET, will be led by Laurel Pickering, MPH, President & CEO of Northeast Business Group on Health, and David Lansky, PhD, President & CEO of Pacific Business Group on ...

By Clifford E. Barnes and Marshall E. Jackson, Jr.

Recent enforcements in home health fraud have highlighted the need for home health companies of every state to engage the State Medicaid payment agency in pro-active affirmative discussion to work together to identify issues related to fraud and abuse.  Such discussions will provide home health companies further insight regarding compliance with federal and state fraud and abuse laws. That being said, recent enforcement actions have shown that home health companies may be liable under fraud and abuse laws, despite efforts to ...

There can be no question that telehealth has gone mainstream.  The numbers speak volumes. Telehealth companies have been able to raise almost $500 million since 2007 according to a noted venture capital analyst.  A recent study indicated that U.S. employers could save up to $6 billion a year through telehealth.  Per the American Telemedicine Association, more than half of all U.S. hospitals now offer some form of telehealth service.  Some leading analysts estimate that global revenue for telehealth will reach $4.5 billion by 2018, and the number of patients using telehealth services ...

As reported previously in this blog and in an EBG Client Alert, FDA has recently reopened the comment periods for three draft guidance documents released this year: two on social media promotion (open until October 29) and one on informed consent information sheets (open until October 27).  FDA does not often reopen the door to comment after the required notice-and-comment period has closed, and the fact that FDA has chosen to do so for these draft guidances is significant.  In all three cases, FDA received communications from stakeholders requesting additional time to digest the ...