Congress reached agreement on the third round of coronavirus-related relief measures (totaling approximately $900 Billion) as this issue was being written. The relevant statutory language is part of the massive Consolidated Appropriations Act, 2021 (the “Act”) and was released on December 21, 2020. Passage by the House and Senate was swift, and approval by the President is expected ...
On Nov. 20, 2020, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) issued two final rules, which implement changes to the Physician-Self Referral Law (Stark Law) and the Anti-Kickback Statute (AKS) regulations (respectively the OIG Final Rule and the CMS Rule, collectively the Final Rules). This alert is a part of the Dinsmore Health Care practice group’s ongoing summary of the Final Rules ...
Summary Proposed FASTER Act defines sesame as a major allergen under the Federal Food, Drug and Cosmetic Act; FDA Draft Guidance recommends the declaration of sesame as an ingredient in flavors and spices. Although non-binding, these actions foreshadow the regulation of sesame as a major food allergen in the future. Two recent legislative actions and an FDA publication address emerging concerns about sesame as an allergen. The U.S ...
Key Points Employers may mandate employee COVID-19 vaccination programs, subject to certain exemptions. When requiring employee vaccinations, employers should consider the fact that these COVID-19 vaccines are currently approved under the FDA's Emergency Use Authorization (EUA). Mandatory employer COVID-19 vaccination programs must include religious and disability-related employee exemptions. INTRODUCTION On Dec ...
Is coronavirus vaccination a cure that will solve many challenges faced by employers or does it just inject further issues for employers to deal with? We answer the key questions. To be vaccinated or not to be vaccinated? That is the question... being discussed in homes and in workplaces up and down the country ...
With employees potentially returning to the workplace, we take a look at what will need to be done to tackle a number of mental health challenges – both for people and the companies they work for. Part three of our mental health series. With the second lockdown now over and the tier system fully in play, some employers are finding themselves able to open and trade again ...
All eyes were on health care in 2020, as the industry faced unprecedented challenges presented by the global coronavirus pandemic. Stories and images of overburdened frontline health care workers dominated the news cycle for most of the year, and the rapid development of one or more seemingly effective vaccines has engendered a cautious optimism for a return to normalcy in 2021 ...
Non-surgical extended duration therapeutic services (NSEDTS) are services which have a significant monitoring component that can: extend for a lengthy period of time, are not surgical, and typically have a low risk of complications after the assessment at the beginning of the service ...
In a recent Malaya High Court decision, the owner of the vessel My Ferry 2 made a claimed based on a maritime lien pursuant to Section 21(3) of the UK Supreme Court Act 1981, which applies in Malaysia pursuant to Section 24(b) of the Courts of Judicature Act 1964.(1) The plaintiff alleged that the first defendant (tug KKD000132-T which had towed the second defendant's dumb barge Wantas 17) had collided into the plaintiff's vessel, the My Ferry 2 ...
On Nov. 20, 2020, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) issued two final rules, which implement changes to the Physician Self-Referral Law (Stark Law) and the Anti-Kickback Statute (AKS) regulations (respectively the CMS Final Rule and the OIG Final Rule, collectively the Final Rules) ...
On November 12, 2020, the Washington Supreme Court extended corporate attorney-client privilege protection to appropriate ex parte communications between defendant hospitals and their non-employee agents. The court’s decision in Hermanson v. MultiCare Health Sys., Inc ...
With many medical practices and healthcare practitioners moving to telemedicine during the COVID-19 pandemic, questions abound on legal requirements, privacy, and the future of healthcare. Schwabe’s Healthcare team has taken a closer look at the legal issues surrounding the rise of telemedicine during the pandemic and the implications for our healthcare future in the four articles below ...
Trademark owners with registrations in EU where the UK is designated should soon receive notification for treatment of registrations and applications following the Brexit transition period. The Brexit transitional period, during which EU laws and rights have continued in force in the UK, will end on December 31, 2020. Thereafter, EU Trade Mark and Design applications and registrations (and designations of the EU) will only cover the remaining 27 EU member states ...
Facts The recent high court decision in Straits Bunkering Pte Ltd v Ketua Pengarah Kementerian Perdagangan Dalam Negeri dan Hal Ehwal Pengguna Johor concerned an application with regard to the vessel MT Abbas, which had been arrested by the Southern Region Marine Department pursuant to Sections 491B(1)(k) and 491C of the Merchant Shipping Ordinance 1952 (MSO 1952).(1) Sections 491B(1)(k) and 491C of the MSO 1952 provide as follows: 491B ...
By resolution adopted on October 7, 2020, the state of emergency has been extended until January 31, 2021 ...
The Ohio Board of Pharmacy (Board) recently issued updated guidance detailing certain conduct pharmacists and other regulated personnel (Licensees) must report to the Board ...
The legal status of CBD, a naturally occurring compound found in the cannabis plant, is murky. Certain Member States are more restrictive about it than others. The Court of Justice of the EU has very recently provided clarification in the context of a preliminary ruling (case C-663/18 of 19 November 2020). This case revolves around CBD’s ban in France, after it had been imported from the Czech Republic where it was lawfully produced ...
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
With the Universal Community Testing Programme for COVID-19 detection by the Hong Kong Government and temperature screening in the workplace, the collection and use of biometric data (such as DNA samples, fingerprints and facial images) have raised concerns among the public. In August 2020, the Privacy Commissioner (PC) has updated its guidance note on how data users should collect and use biometric data in compliance with the Personal Data (Privacy) Ordinance (Guidance Note) ...
On November 16, 2020, the Office of Inspector General of the Department of Health and Human Services (OIG) issued a Special Fraud Alert addressing the fraud and abuse risks of speaker programs that are commonplace in the pharmaceutical and medical device industries ...
Norway has acceded to the Cape Town Convention on International Interests in Mobile Equipment and its Protocol on Matters Specific to Aircraft Equipment (the «CTC»). The CTC has been implemented and given effect under Norwegian law as of 1 April 2011. It is still possible to register security interests over an aircraft with the Norwegian Civil Aircraft Registry («NCAR») ...
On November 12, 2020, the Federal Trade Commission (FTC) sued to block the acquisition of two Memphis-area hospitals by Methodist Le Bonheur Healthcare. Eleven months earlier, on December 12, 2019, Methodist entered into an agreement with Dallas-based Tenet Healthcare Corporation to purchase Saint Francis-Memphis and St. Francis-Bartlett (along with their associated physician practices, urgent care centers, and other ancillary care providers) for $350 million ...
A minority of states have enacted statutes and taken other action to protect business owners from claims by persons who allegedly were infected by COVID-19 on their premises.1 The purpose of this article is to compare these statutes and discuss some of the differences between them. This article addresses statutes in effect as of October 27, 2020. The article does not address pending legislation ...
Buyers’ Default Clause 13 of Saleform 2012 regulates Buyers’ default. The potential Buyers’ defaults are quite restricted to payment defaults. There are no Buyers’ default linked to failure to take over the Vessel (like you often find in shipbuilding contracts) or failure to provide the agreed documents. Nor is it likely that a Buyer will pay for the Vessel but not accept physical delivery ...
