Life Sciences Perspectives

As the COVID-19 pandemic progresses and the expanded use of telehealth has appeared to stabilize over the past year according to a July report from McKinsey & Company, Federal agencies have continued the recent trend of enforcement actions and audits of telehealth providers. On September 17, 2021, the U.S. Department of Health and Human Services Office of Inspector General (HHS OIG) and U.S. Department of Justice (DOJ) announced their latest enforcement action, totaling…
The use of telehealth continues to grow rapidly across the U.S.  Given legislative proposals and the Centers for Medicare & Medicaid Services efforts to expand access to telehealth, we can only anticipate that remotely engaging with healthcare providers is here to stay.   In fact, the National Center for Health Statistics and the Centers for Disease Control and Prevention reported that between April and July 2021, 24.5% of adults in the U.S. had a virtual care…
The Department of Justice (“DOJ”) has reported that in 2020, the government prosecuted dozens of laboratory owners and operators for anti-kickback related offenses responsible for hundreds of millions in alleged federal health care program loses.  DOJ recouped a total of $1.8 billion dollars in connection with healthcare fraud allegations. Since the public health emergency was announced in March 2020, the Centers for Medicare & Medicaid Services, the U.S. Department of Health and Human Services (“HHS”),…
The pandemic has spared no industry. The life sciences industry knows this well and perhaps learned this lesson the hardest way during the pandemic when overseas supply shipments were delayed or, worse, when overseas manufacturing facilities were shut down because of government-mandated quarantines. Producing novel biologics is, unfortunately, not so easy to pick up and relocate, especially during a pandemic and even moreso when there are not enough domestic producers to begin with. As the…
The Biden Administration’s withdrawal of the Trump Administration’s proposal to exempt 84 medical device types from the FDA’s premarket notification, or 510(k), requirement, underscores the promotional framework that developers and marketers of these devices are subject to.  The Trump Administration proposal included devices critical to combating the COVID-19 public health emergency, ranging from personal protective equipment and ventilators to remote patient monitoring and other types of digital health devices. Read more about promotional considerations for…
Rule 10b5-1 trading plans have faced increased scrutiny since the onset of the COVID-19 pandemic and the corresponding public focus on stock sales by executives of public life sciences companies. On June 7, 2021, SEC Chairman Gary Gensler continued that scrutiny when he delivered prepared remarks to the Wall Street Journal’s CFO Network Summit concerning Rule 10b5-1 trading plans and his view that “these plans have led to real cracks in our insider trading…