The Path to Compliance: a Spotlight on Ted Banks

Posted on October 15, 2018Categories Compliance Spotlight, The Art of Compliance

Ted Banks is a partner at the firm Scharf Banks Marmor and is also an adjunct professor at Loyola University Chicago School of Law, where he teaches a course on corporate compliance. At Scharf Banks Marmor, Mr. Banks concentrates his practice on compliance, antitrust, food law, and other corporate issues. He entered compliance by accident many years ago, and has been an innovator in the field ever since. Mr. Banks has been recognized as an Illinois “Super Lawyer” in the areas of corporate governance and compliance, and he has also been named a Risk & Compliance Trailblazer and Pioneer by the National Law Journal. Here, he has shared his story, tells us the real deal about compliance, and gives advice to students who wish to make compliance their career.

FDA Warns E-Cigarette Manufacturers: Stop Teen Epidemic or Face Consequences

Posted on October 10, 2018Categories Drugs & Devices

The rise of electronic cigarettes was initially met with relaxed FDA regulation given optimism that they could help adult smokers curb use of more toxic combustible cigarettes. This optimism was in spite of e-cigarettes’ growing popularity among adolescents and young adults. On September 12, the FDA signaled a pivot from this approach when FDA Commissioner Scott Gottlieb described youth e-cigarette use as having reached epidemic proportions. Gottlieb announced that the FDA had issued more than 1,300 warning letters and fines to retailers caught selling e-cigarette products to minors. It also issued an order to the five major e-cigarette manufacturers (Juul, Vuse, Blu, MarkTen XL, and Logic) to each submit a plan outlining how the company will address youth access and use of their products. Failure to submit a sufficient plan could lead the FDA to revisit its earlier decision on flavored e-cigarette products, which allowed manufacturers a grace period until 2022 to receive FDA approval.

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Battle in Arizona to Adjust State Water Use Regulations as Climate Change Causes Supplies to Dwindle

Posted on October 9, 2018Categories Uncategorized

On March 14, 2018, the United States Department of Agriculture officially designated twelve Arizona Counties as primary natural disaster areas on account of agricultural loses brought on by intensifying drought. Despite being one the hottest and driest states in the nation, the state is one of the most agriculturally productive, sustaining a multi-billion dollar industry. As drought threatens this economic boon, competing interest groups petition the state legislature to adjust water-use regulations that have failed to stem shortages.
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Regulatory Rollbacks: Changing the Career Education System

Posted on October 8, 2018Categories Uncategorized

In a world where students are swimming in debt, the Education Department has made an effort to regulate career education and ensure students receive a quality education. During the Obama Administration, rules were implemented that require educational institutions to prove they are preparing graduates for gainful employment. In addition, the borrower defense rule allows for federal student loan forgiveness when the student can prove their institution misled them relating to the loan or education services provided. With so many students in debt, what is the appropriate standard of review to apply when determining these regulations?
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Electronic Health Record Compliance Measures Benefit Patient Centered Care

Posted on October 7, 2018Categories HIPAA & Health Information

In a time when data breaches occur fairly frequently, whether it’s credit card information being stolen from department stores or a credit reporting bureau breach affecting hundreds of millions of customers, keeping personal information private seems to get harder every day. That fact may give patients pause when they are asked to sign up for an electronic health record account. A 2017 survey listed electronic health record management as one of patients top concerns. Changes in recent years have led to changes in compliance measures that make electronic health records security an added benefit to patients and ensure the continued increase of their adoption.
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Black Market Midwifery: Lack of Regulation Compromises the Safety of Women Who are Committed to Giving Birth Outside the Hospital Setting

Posted on October 4, 2018Categories Uncategorized

Across the United States more and more women are choosing to give birth outside of hospitals. Currently, in Illinois, Certified Professional Midwives are not licensed to provide home birth services. However, over the last decade, advocates in Illinois have urged lawmakers to reconsider this restriction. The most recent attempt in 2017 was unsuccessful once again. While opponents argue that individuals with this level of training should not be providing care to women during delivery, the choice for women who are committed to home birth is not between home and the hospital. It is between home and an illegal or unassisted delivery.
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FDA Declares War on Flavored E-Cigarette

Posted on October 2, 2018Categories Drugs & Devices, The Marketplace

In July 2017, the Food and Drug Administration revealed a new policy that sought to reduce the deaths and diseases caused by smoking which takes nearly 500,000 lives annually in the United States. In early September 2018, the FDA followed up on its mission by unveiling a plan to address the e-cigarette epidemic. E-cigarettes, and in particularly, a brand of flavored e-cigarettes called “JUULs,” have taken the teenage and adolescent market by storm. While the FDA is primarily concerned with reducing the overall number of smoking-related casualties, it notes a particular concern for a vulnerable young demographic and the effects of nicotine intake on a developing brain.
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DeVos’ Deregulation Attempt Fails as Judge Upholds Borrower Defense Rules

Posted on October 1, 2018Categories Uncategorized

A new set of student loan forgiveness regulations introduced earlier this year aimed to hack away at “borrower-defense” protections which shielded students from predatory loan practices by for-profit universities. Under Education Secretary Betsy DeVos, the Department of Education crafted new, more restrictive borrower-defense regulations after blocking an Obama Administration regulation from going into effect last year. U.S. District Court Judge Randolph Moss sided with consumer rights activists who argued against the Secretary of Education, alleging the Department of Education violated federal law and procedure by repealing the Borrower Defense to Repayment rule. The Trump Administration requested another opportunity to delay the regulations from taking effect, but Judge Moss has not yet ruled on their request. 
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A Way Around HHS 340B Program Delays

Posted on September 28, 2018Categories Drugs & Devices

Access to quality, comprehensive health care services seems to always be at the forefront of our health care industry. One’s ability to gain access measured in terms of utilization, is dependent upon financial affordability, and physical accessibility. While a seemingly small issue under the overarching ‘access to health care’ topic, talks about access to medication and its affordability in particular for the vulnerable and underinsured patients must also be addressed. A number of health organizations have sued HHS for delaying the implementation of rules that would force drug companies to be transparent about their pricing and punish them for overcharging participating hospitals in the federal program that discounts outpatient medication. Due to HHS’ delays, hospitals cannot challenge drug manufacturers for overpricing outpatient medication thus they cannot access refunds of discounts that are due to them under statute. 
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