Summary Proposed FASTER Act defines sesame as a major allergen under the Federal Food, Drug and Cosmetic Act; FDA Draft Guidance recommends the declaration of sesame as an ingredient in flavors and spices.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 ...
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 ...
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 ...
The Paycheck Protection Program (the “PPP”) was passed into law by Congress as part of the CARES Act earlier this year in response to the COVID-19 pandemic. While considered a relative success at its intended goal of temporarily preserving jobs during the pendency of the pandemic, the PPP ended its initial run with tens of billions of dollars left on the table and frustrated borrowers and lenders because of opaque and frequently changing rules and regulations ...
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 ...
In light of the Food and Drug Administration’s approval of new COVID-19 vaccines, the Equal Employment Opportunity Commission (EEOC) has issued new guidance on the legal implications of the COVID-19 vaccine under federal anti-discrimination laws. Employers should carefully consider these points when making decisions about employee vaccinations. 1. Employers can require employees to receive a COVID-19 vaccination ...
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 ...
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) ...
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 ...
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 ...
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 ...
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) ...
The Department of Health and Human Services (HHS) released a Special Fraud Alert from the Office of Inspector General (OIG) highlighting the fraud and abuse risks associated with the offer, payment, solicitation, or receipt of remuneration related to speaker programs sponsored by healthcare companies ...
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 ...
The Department of Health and Human Services (HHS) further codified the shift to a value-based care model with the first major overhaul of both the Stark Law and Anti-Kickback Statute since they were first introduced three decades ago. Earlier this week, the White House completed the final review of the changes, and on Friday, Nov ...
The White House has completed the final review to clear a path for the Department of Health and Human Services (HHS) to publish the final rule to modernize and clarify regulations promulgated for the Stark Law and Anti-Kickback Statute. In June 2018, HHS Deputy Secretary Eric Hargan announced a regulatory reform initiative entitled the “Sprint to Coordinated Care ...
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 ...
