Month:

November 2018

Illinois Law Makers Seeking to Curb E-Cigarette Use Among Teens and Children

In the wake of rising e-cigarette use among teens and children, Illinois lawmakers seek a legal solution to protect Illinois youths from smoking-related illnesses and pre-mature death. Illinois’s Congress introduced Tobacco 21, a bill designed to raise the legal age to purchase tobacco products like e-cigarettes to 21 years of age. Despite a lack of support from Governor Bruce Rauner, Illinois politicians continue to fight to save the bill, and with good reason. The United States Food and Drug Administration (FDA) recently announced its Youth Tobacco Prevention Plan, which addresses the rising e-cigarette use among adolescents. The FDA’s plan is two-fold: (1) crack down on the sale and marketing of e-cigarettes and (2) educate teens and children about the dangers of using e-cigarettes. Tobacco 21 provides support for the FDA’s Plan.

Protections for Accused Students or Problems for Victims?

The Trump administration has proposed new rules for schools dealing with sexual assault and harassment allegations that narrow the definition of sexual harassment and offering greater protections for the accused. Under the new rules, the Education Department is altering the procedures colleges that receive federal funding use to adjudicate complaints of assault and harassment. The new proposed rules come during the #MeToo movement, which will likely prove to be very controversial to both those who support the changes and those who oppose the changes. The federal guidelines stem from Title IX, which bars sex discrimination at schools that receive federal funding.

Trump’s Holiday Gift for E-Commerce

Just in time for holiday shopping, and at the beginning of Q4, President Trump delivered some news for holiday shoppers. In what shocked some, but others found as expected and inevitable, President Trump continued his message to the world that the US will not be “handing out donations” much longer. His latest re-negotiation to bring dollars back to the US has left overseas ecommerce providers wondering what the latest move in this Administration’s financial overturn is going to do for their business. It’s not the big players like Amazon that’ll feel the brunt of this, but the smaller players in the eCommerce space that outsource their products overseas may feel a hit in their margins as this move by Trump takes its toll.

International Concerns Regarding Southeast Asian Aviation

Aviation accidents, though rare, occur all over the world. However, the relatively high frequency of airplane disappearances and fatal incidents in Southeast Asia has been a primary cause of concern within the industry. Most recently, on October 29, 2018, a Boeing 737 Max 8 operated by Indonesian airline Lion Air crashed into the Java Sea off the coast of Jakarta. Just thirteen minutes into a scheduled hour-long flight, all 189 passengers and crewmembers aboard the aircraft lost their lives. Almost immediately,speculation arose regarding the cause of the accident as well as questions regarding the common occurrence of Indonesian aviation disasters.

Compliance Spotlight: Cheryl Miller, JD, CHC

Cheryl Miller is the Director of Risk, Compliance and Legal – and Chief Compliance Officer for Presbyterian Homes, a Life Plan Community (formerly branded as a Continuing Care Retirement Community (CCRC)) in Skokie, Illinois. Ms. Miller worked as a corporate paralegal for several years before and during law school, first at a large law firm and then at Brookdale Senior Living. She moved into healthcare regulatory work, and from there learned about the Health Care Compliance Institute and went to the annual meeting.  “The preciseness of Stark and Anti-Kickback and the other multitude of regulations enthralled me. I was on-site at a client (Presbyterian Homes) two days per week providing risk management services.  I asked about their compliance program and gave (what I thought was) constructive criticism.  A year or so later, Presbyterian Homes hired me away from the firm.” Ms. Miller was recently invited by Professor Larry Singer to speak to his Health Care Business and Finance class about the Long-Term Care industry. Her discussion enlightened many of the students and inspired enrollment in Loyola’s Long-Term Care course. The following is an interview that highlights her insight and experiences about her work in an often-overlooked area of healthcare. 

The SUPPORT Act of 2018: New Anti-Kickback Provisions

On October 24, President Trump signed a new bill aimed at combatting issues arising from the opioid epidemic. This bill, entitled the Substance-Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (the “SUPPORT” Act) is a combination of seventy bills that effect the healthcare industry. This act includes new and revised Medicaid and Medicare laws that relate to the opioid crisis through the expansion of substance use disorder services. However, this bill, primarily aimed to combat the opioid epidemic, contains key provisions that will affect healthcare providers. Healthcare providers should be especially mindful of this new Act, as there are new anti-kickback provisions that require compliance officers and departments to ensure that their healthcare entities are in compliance with this new law.

Amazon Go versus the GDPR

New data privacy regulations entail questioning both current and future technologies. Recently, Amazon has introduced a store concept that eliminates everyone’s least favorite things about shopping, long lines and small talk. Amazon Go is the grocery store of the future and these stores allow consumers to walk in, pick up the items that they need, and then walk right back out. That’s it. No long lines, no cashiers, no shopping carts. However, as great as this concept seems, there are still concerns from a data privacy standpoint as Amazon needs to collect personal data from its consumers in order to be able to lawfully execute these checkout-less stores.

City of Chicago Paid Sick Leave Ordinance Gaining Momentum

The City of Chicago enacted the Paid Sick Leave Ordinance to protect employees who work within the city limits. Effective July 1, 2017, the Ordinance requires employers who operate or conduct business in the City of Chicago to provide Paid Sick Leave to eligible employees. While there are some limitations about who is a “Covered Employee,” the Ordinance sets a precedent for worker’s rights. Only eight states have enacted Paid Sick Leaves Laws. Illinois is not one of those states; however the City of Chicago may be moving Illinois workers one step closer to mandatory paid sick leave.

EU Copyright in the Internet Age

On September 12, 2018, the European Parliament approved amendments to the Directive on Copyright in the Digital Single Market, commonly known as the EU Copyright Directive (the “Directive”). The amendments primarily cover copyright protection over internet resources. There are two parts of the Directive that have caused concern: Articles 11 and 13. Article 11, also referred to as the “link tax,” provides publishers with a method to collect revenue from news content shared online. Article 13, also referred to as the “upload filter,” holds Internet platforms, such as Facebook and Twitter, liable for copyright infringement committed by users. Together, large and small platform providers that would have to comply with these new regulations have declared that the enactment of these articles places a heavier burden on service providers. Critics of these amendments also say the requirements are likely to lead to increased taxation and more lawsuits. The final vote on the directive is scheduled for January 2019.

Impact of Provisions of Revised Rules of FDA-Regulated Clinical Investigations

The FDA regulationson human subject protection and Institutional Review Boards(IRBs) provide guidance to protect the rights, safety, and welfare of subjects who participate in FDA-regulated clinical investigations. The regulations conform with the requirements set forth by the Department of Health and Human Services (HHS) Federal Policy of Human Research Subjects(45 CFR 46, part A).  In order to reduce confusion and burdens associated with complying with both the FDA regulations and the HHS policies regarding human subject protections, the FDA is revising the current “common rule”.