Health Law Advisor

On July 8, 2019, Anthony Camillo, owner of Allegiance Medical Laboratory and AMS Medical Laboratory, was sentenced to 30 months in prison by a federal judge in the Eastern District of Missouri. He was ordered to pay $3.4 million in restitution for violations of the anti-kickback statute, associated conspiracy charges, and illegal kickbacks related to various health care fraud schemes to defraud federal health care benefit programs. Those operating in the clinical laboratory testing space or referring specimens to such laboratories should know that what happened in this case is ...

On July 2, 2019, New Jersey joined Illinois, Nevada, New Mexico, New York City, and Oklahoma in enacting employment protections for authorized users of medical cannabis. New Jersey’s new medical cannabis law (“Law”), which became effective upon signing by Governor Phil Murphy, amends the state’s Compassionate Use Medical Cannabis Act (“CUMCA”),[1] N.J.S.A. 24:61-2, et seq. Among other measures, the Law prohibits employers from taking an adverse employment action against a current or prospective employee based on the individual’s status as a registered ...

On June 5, 2019, Governor Steve Sisolak of Nevada signed AB 132 (the “Law”), which prohibits employers from declining to hire a prospective employee based on pre-employment marijuana drug tests. On the heels of a new New York City law which prohibits employers from requiring pre-employment drug testing for marijuana and tetrahydrocannabinols (the active ingredient in marijuana), Nevada is now the first state to prohibit employers from using pre-employment drug tests to screen out applicants who use marijuana.

Under the Law, beginning January 1, 2020, employers in Nevada ...

The market for direct-to-consumer (“DTC”) genetic testing has increased dramatically over recent years as more people are using at-home DNA tests.  The global market for this industry is projected to hit $2.5 billion by 2024.  Many consumers subscribe to DTC genetic testing because they can provide insights into genetic backgrounds and ancestry.  However, as more consumers’ genetic data becomes available and is shared, legal experts are growing concerned that safeguards implemented by U.S. companies are not enough to protect consumers from privacy risks.

Some states vary ...

On June 4, 2019, the Illinois legislature passed the Cannabis Regulation and Tax Act (the “Cannabis Act”).  Under the Cannabis Act, Illinois residents over 21 years of age may legally possess 30 grams of marijuana flower and five grams of marijuana concentrate for their personal use, starting January 1, 2020.  The 610-page Cannabis Act also provides the most extensive workplace protections for employers of any marijuana legalization statute around the country. Indeed, the Illinois General Assembly declares at the beginning of the Cannabis Act that “employee workplace ...

On February 27, 2019, Tennessee-based holding company Vanguard Healthcare, LLC (“Vanguard”), agreed to pay over $18 million to settle a False Claims Act (“FCA”) action brought by the United States and the state of Tennessee for “grossly substandard nursing home services.” The settlement stems from allegations that five Vanguard-operated facilities failed to do the following: (1) administer medications as prescribed, (2) provide standard infection control resulting in urinary tract and wound infections, (3) attend to the basic nutrition and hygiene ...

On May 31, 2019, the U.S. Food and Drug Administration (“FDA”) hosted its much-anticipated public hearing titled “Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds” (discussed in our prior blog post). The day-long hearing presented an opportunity for FDA panel members to engage directly with stakeholders on the regulatory future of cannabis or cannabis-derived products within the scope of FDA’s jurisdiction.

Acting FDA Commissioner Ned Sharpless, M.D., kicked off discussions, reminding the panel and ...

Our Employee Benefits and Executive Compensation practice now offers on-demand "crash courses" on diverse topics. You can access these courses on your own schedule. Keep up to date with the latest trends in benefits and compensation, or obtain an overview of an important topic addressing your programs.

In each compact, 15-minute installment, a member of our team will guide you through a topic. This on-demand series should be of interest to all employers that sponsor benefits and compensation programs.

In our newest installment, Cassandra Labbees, an Associate in ...

When we think about the top players in the medical device development space, we often see device company sponsors, clinicians, scientists, and FDA regulators as the ones driving the process. But what about the patient perspective? Does that get factored in?

On May 3, 2019, FDA established a docket to collect public input on a proposed list of patient preference-sensitive areas for medical device review, and posed certain related questions (comments are due July 2, 2019). By identifying these key areas (which it committed to as part of the reauthorization of the Medical Device User Fee ...

Following a two-day meeting by a Food and Drug Administration (“FDA”) advisory committee on breast implant safety earlier this year, FDA on May 2, 2019, released a statement announcing that no breast implant models will be banned from the U.S. market at this time. Also described in the statement are a number of measures the agency is undertaking in order to assist women in making more informed decisions regarding breast implants.

The March 26, 2019, meeting of the General and Plastic Surgery Devices Panel was convened to discuss issues and concerns related to the benefit-risk ...