Health Law Advisor

Health care providers, life sciences companies and other entities subject to regulation by the Food and Drug Administration ("FDA") or the Centers for Medicare & Medicaid Services ("CMS") should be aware that the U.S. Department of Health and Human Services ("HHS") is increasing the maximum civil monetary penalty amounts that may be assessed by the agency.

The new maximum adjusted penalty amounts may have a significant impact on entities that violate or fail to meet mandatory reporting requirements set by FDA or CMS. Of the 299 enumerated increased fines, 137 fines (45.8%) have ...

When: Tuesday, October 18, 2016 8:00 a.m. – 4:00 p.m.

Where: New York Hilton Midtown, 1335 Avenue of the Americas, New York, NY 10019

Epstein Becker Green’s Annual Workforce Management Briefing will focus on the latest developments in labor and employment law, including:

• Latest Developments from the NLRB
• Attracting and Retaining a Diverse Workforce
• ADA Website Compliance
• Trade Secrets and Non-Competes
• Managing and Administering Leave Policies
• New Overtime Rules
• Workplace Violence and Active-Shooter Situations
• Recordings in the Workplace
• Instilling Corporate Ethics

The Medicare Payment Advisory Commission ("MedPAC") met in Washington, DC, on September 8-9, 2016. The purpose of this and other public meetings of MedPAC is for the commissioners to review the issues and challenges facing the Medicare program and then make policy recommendations to Congress. MedPAC issues these recommendations in two annual reports, one in March and another in June. MedPAC's meetings can provide valuable insight into the state of Medicare, the direction of the program moving forward, and the content of MedPAC's next report to Congress.

As thought leaders in ...

Featured on Employment Law This Week:  The Equal Employment Opportunity Commission (EEOC) has issued new guidance on workplace retaliation.

The EEOC’s final guidance on retaliation includes concrete examples of retaliation issues that the courts have largely agreed upon, as well as expanded definitions of “adverse action” and “causal connection.” The guidance also describes “promising practices” for reducing the possibility of retaliation, including anti-retaliation training and proactive follow-up with potential targets. Retaliation has become the ...

On August 29, 2016, the EEOC issued its final Enforcement Guidance on Retaliation and Related Issues (Guidance) to replace its 1998 Compliance Manual section on retaliation, including tips on ADA interference. The Guidance reflects the Commission’s consideration of feedback received on the proposal from about 60 organizations and individuals following a 30-day public input period that ended February 24, 2016. The changes in the Guidance are in line with the EEOC’s efforts to broaden the conduct that would be deemed retaliatory as well as the concept of causation.

Along with ...

In employment litigation, plaintiffs often rely on the “cat’s paw” doctrine to hold their employers liable for discriminatory or retaliatory animus of a supervisory employee who influenced, but did not make, the ultimate employment decision.  On August 29, 2016, the United States Court of Appeals for the Second Circuit, in Vasquez v. Empress Ambulance Service, Inc., greatly extended the reach of the “cat’s paw,” holding that the doctrine could be applied to hold an employer liable for an adverse employment decision that was influenced by the discriminatory or ...

On August 31, 2016, FDA issued a notification of public hearing and request for comments on manufacturer communications regarding unapproved uses of approved or cleared medical products. The hearing will be held on November 9-10, 2016, and individuals wishing to present information at the hearing must register by October 19, 2016. The deadline for written comments is January 9, 2017.

In the notice, FDA posed a series of questions on which it is seeking input from a broad group of stakeholders, including manufacturers, health care providers, patient advocates, payors, academics ...

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 ...