The Federal Communications Commission (“FCC”) established the COVID-19 Telehealth Program (the “Telehealth Program”) on April 2, 2020 in response to the COVID-19 pandemic. The Telehealth Program provides $200 million in funding, appropriated by Congress as part of the CARES Act,[1] to assist certain non-profit and public healthcare providers in making telehealth services available to patients who cannot be seen in person ...
The new measures adopted by the European Commission Last Friday, the European Commission (“Commission”) has adopted an amendment to existing State aid rules to widen the perimeter of the national measures which can be authorized based on the exceptional legal framework to cope with the current crisis. a. In particular, the Commission considered the following measures:a. More support for research and development related to the current health crisis ...
With the COVID-19 Public Health Emergency (PHE) set to end on May 11, 2023, federal agencies have published FAQs explaining how the end of the PHE will affect previously extended deadlines relating to COBRA, HIPAA special enrollment, and claims and appeals under group health plans. This article provides (i) a recap of the deadlines, (ii) rules of thumb for determining the deadlines, and (iii) tables more specifically addressing some of the most common deadlines that arise ...
Dinsmore health care partner Joseph Zielinski was published in the most recent edition of New Perspectives on Health Care Risk Management, Control and Governance, the publication of the Association of Health Care Internal Auditors. His article, "The Effectiveness of Your Compliance Program," covers how to effectively audit your organization's compliance program while gaining valuable insights. An excerpt is below ...
On April 9, 2020, the Equal Employment Opportunity Commission (EEOC) issued Q&As on COVID-19 issues. The EEOC has also updated its guidance during a pandemic for employers relating to the COVID-19 pandemic. The following are some highlights from these updates. Medical Inquiries and Exams In the updated guidance, the EEOC indicated that the COVID-19 pandemic meets the definition of a direct threat ...
Last week, the Equal Employment Opportunity Commission (“EEOC”) updated its COVID-19 guidance to address workplace issues related to COVID-19 vaccines, including mandatory vaccination policies. According to the EEOC, employers may mandate vaccines, but must attempt to accommodate employees who refuse vaccination because of disability or a sincerely held religious belief, practice, or observance ...
The draft regulations for OTC derivatives have been released, which means that change is in the air. The government is stepping forward into unchartered territory and is set to regulate an area which has never been regulated before. Following our recent breaking news on the draft regulations, ENSafrica will, over the coming weeks and months, unpack the regulations for you, highlighting all the essentials. What follows is a sneak peak at affected areas and a snapshot of the bigger picture ...
As you already know, COVID-19 changed almost everything, and some of those things are likely here to stay (or at least linger for a while longer). One widespread change is the increased use of videoconferencing. In early 2020, a videoconference was a rarity, but now we Zoom in and out of classrooms, work meetings, and court appearances. Not surprisingly, the virtual world has reached the doctor’s office ...
As workplaces continue to reopen, the U.S. Department of Labor (DOL) and Centers for Disease Control and Prevention (CDC) issued additional guidance addressing various return to work issues and leave under the Family and Medical Leave Act (FMLA) and Families First Coronavirus Response Act (FFCRA). The new DOL guidance, summarized below, appears on the DOL’s FFCRA Questions and Answers page ...
On Nov. 30, 2021, the U.S. Supreme Court heard oral arguments from a coalition of hospital plaintiffs who are challenging Medicare’s nearly 30% reduction in outpatient drug reimbursement rates for 340B Program-participating hospitals ...
The hemp industry's explosive growth following the 2018 Farm Bill has produced a number of consequences, some intended and many more almost certainly never considered by lawmakers. The development of THC acetate ester (THCO), a synthetic substance created from hemp, almost certainly falls within the latter category. Recently, THCO has gained substantial popularity. In a Feb ...
On 21st July 2022, the COVID-19 Inquiry was opened. Module 1 will consider the extent to which the risk of a Coronavirus pandemic was properly identified and planned for and whether the UK was ready for that eventuality. In broad terms, the module will look at the UK’s preparedness for whole-system civil emergencies, including resourcing, the system of risk management and pandemic readiness ...
The recent COVID-19 Inquiry's public consultation on its draft terms of reference has captured a substantial amount of public engagement; balancing the representation of all affected groups and avoiding lengthy delays looks like a real challenge. Baroness Hallett’s draft terms of reference (draft terms), published on 11 March, requested the views of individuals and organisations by 7 April on the scope of the COVID-19 Inquiry ...
Shoosmiths’ Public Inquiries team is delighted to present a series of podcasts in respect of reflections and experiences of the COVID-19 pandemic. Hosted by Hayley Saunders and Alex Friston, we are delighted to be joined by a variety of speakers, each bringing something different to the table in relation to impacts, views and then thoughts towards the Public Inquiry, which is set to commence its first public hearings on 13 June ...
On 21 July 2022, Baroness Heather Hallett issued an opening statement in respect of the COVID-19 Inquiry ('the Inquiry'). As Chair, Baroness Hallett expressed her determination to “run the Inquiry as thoroughly and as efficiently as possible” and “to undertake and conclude the work of this Inquiry as speedily as possible so that lessons are learned before another pandemic strikes ...
SVW has, across its offices, been giving guidance to clients both under English and Norwegian law as to the Coronavirus impact on shipping contracts, including on force majeure and similar exceptions clauses, and contract frustration. Read our recent publication, touching upon these issues. The Covid19 Virus Only two months have passed since the novel coronavirus was detected in Wuhan, China ...
The Centers for Disease Control and Prevention has expanded the definition of close contact to now evaluate exposure cumulatively over a 24-hour period such that “15 cumulative minutes of exposure at a distance of 6 feet or less can be used as an operational definition for contact investigation,”[1] Because the newly expanded definition is not limited, it impacts many different industries (inclu
On October 21, 2020, the Center for Disease Control (CDC) published a new guidance for use by contact tracers that clarifies what had been a somewhat fuzzy definition of “close contact.” The new definition increases the number of individuals presumed to have an exposure to COVID-19, and will significantly affect schools and workplaces since those presumptively exposed individuals will be asked to isolate for a period of 14 days ...
On Wednesday, April 26, 2017, the Supreme Court heard oral argument in Sandoz Inc. v. Amgen Inc. et al., a landmark case that many hope will provide clarity and guidance for consumers and the pharmaceutical industry on the regulatory approval pathway for biosimilar drugs under the Biologics Price Competition and Innovation Act of 2009 (“BPCIA” or “Biosimilars Act”) ...
In its priorities note for 2023, the Belgian Competition Authority (“BCA”) listed the pharmaceutical and health care sector as one of it major interests. It noted that “in the coming months, the BCA will also devote additional attention and resources to the continued consolidation in the hospital sector ...
On March 25, 2020, Governor Jim Justice signed into law House Bill 4497, which shall be known as The Alex Miller Law. The Alex Miller Law will take effect June 5, 2020, but the mandated requirements do not take effect until the 2021-2022 school year. Alex Miller, was a Roane County football player who collapsed and died during a high school football game. The Alex Miller Law (W. Va. Code 18-5-25c) requires defibrillators (AED devices) at certain events by the 2021-2022 school year ...
Both the Belgian legislator and government have played an active role in 2023 when it comes to pharma legislation, which has led to a number of changes in the legal framework. In this article, we look back and discuss five noteworthy developments in Belgian pharma law. 1 ...
The 2020 Investment Priorities Plan (2020 IPP) has been promulgated by the Philippine President under Memorandum Order No. 50 dated November 18, 2020 (https://www.officialgazette.gov.ph/downloads/2020/11nov/20201118-MO-50-RRD.pdf), and it became effective on December 6, 2020. The IPP is issued pursuant to the Omnibus Investments Code of 1987 (Executive Order No. 226), as amended (Omnibus Investments Code) ...
The ongoing COVID-19 pandemic crisis—infecting more than 2.7 million people worldwide, with almost 870,000 cases in the United States alone as of the writing of this article—has thrown nearly every industry into chaos as the world struggles to adjust to the new reality of social distancing and self-quarantining ...
The ongoing COVID-19 pandemic crisis—infecting more than 2.7 million people worldwide, with almost 870,000 cases in the United States alone as of the writing of this article—has thrown nearly every industry into chaos as the world struggles to adjust to the new reality of social distancing and self-quarantining ...
