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 ...
The Ohio Department of Health’s July 23, 2020 Order regarding facial covering mandates has been amended in light of the increasing number of COVID-19 cases in Ohio. The order became effective today, Nov. 16, 2020. See the order here. This new order includes the following additional mandates for retail stores (enterprises offering goods to the public) only. 1. Each business will be required to post at all public entrances to the store: A. A face covering requirement sign; B ...
On November 16, 2020, the Department of Health and Human Services Office of Inspector General (HHS OIG) issued Special Fraud Alert: Speaker Programs (Fraud Alert) to “highlight the fraud and abuse risks associated with the offer, payment, solicitation, or receipt of remuneration relating to speaker programs by pharmaceutical and medical device companies ...
In this report, you will find a summary of two important decrees published yesterday in the Official Gazette. Regulatory Decree of Law No. 27,350 of medical and scientific research on the medicinal use of the cannabis plant and its derivatives By means of Executive Branch’s Decree No ...
The HHS Office for the National Coordinator of Health Information Technology issued an interim final rule on October 29, 2020, extending the compliance date for the information blocking rule under the 21st Century Cures Act to April 5, 2021 ...
The Joint Resolution No ...
Introduction The rapid spread of COVID-19 pandemic has led to a significant increase in demand for medical devices (MDs) and personal protective equipment (PPE), masks for social use (textile articles) and other products destined to prevent the spread of the disease. As a result, it became clear that there was insufficient supply to meet existing needs during the state of emergency and the subsequent period ...
IP landscape While the world is in the grip of the deadly COVID-19 pandemic, the patenting of pharmaceutical and biological compositions and the launch of generic products is even more hotly debated than before, particularly in the world's developing and least-developed countries ...
If a branded medicine and its generic version are put on the EEA market by economically linked undertakings, is a parallel importer then allowed to rebrand and repackage the imported generic version as the branded reference medicine? This has been a hotly debated issue in recent years and recently led the Brussels Court of Appeal (CoA) to refer three questions to the European Court of Justice (ECJ) (Cases C-253/20 and C-254/20) ...
Belgium is, for the second time, in lockdown. The new Ministerial Decree of 1 November 2020 stipulates that, as from today until 13 December 2020, all workers are obliged to telework. However, an exception applies when either the employee’s role or the continuity of business operations, activities and services does not allow for teleworking ...
On October 20, 2020, San Francisco County was upgraded to the “minimal” tier within the California COVID-19 tracking system, meaning it has the fewest restrictions on reopening all businesses as promulgated by the State of California. In order to qualify for the “minimal” tier, a county must have an infection rate of less than one daily new positive COVID case per 100,000 residents and have a positive test rate of less than 2% for two consecutive weeks ...
On October 20, 2020, San Francisco County was upgraded to the “minimal” tier within the California COVID-19 tracking system, meaning it has the fewest restrictions on reopening all businesses as promulgated by the State of California. In order to qualify for the “minimal” tier, a county must have an infection rate of less than one daily new positive COVID case per 100,000 residents and have a positive test rate of less than 2% for two consecutive weeks ...
The U.S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) released an interim final rule on October 29, 2020, delaying the implementation of the information blocking rule under the 21st Century Cures Act (Information Blocking Rule) ...
Due to the worrying evolution of the epidemiological situation currently afflicting the country, Presidential Decree no. 276/20 of 23 October 2020 has been enacted to update the preventive and control measures for the spread of COVID-19. Overall, there is a strengthening of the previous preventive measures established in Presidential Decree no. 256/20, of 8 October 2020 ...
The coronavirus disease (COVID-19) outbreak continues to put pressure on the public and private sectors alike. As we are entering new phases of the COVID-19 pandemic, we have to switch our focus towards safely and gradually reopening our businesses and economies while continuing to implement prevention measures ...
On Oct. 21, 2020, the Centers for Disease Control and Prevention (CDC) released a new definition for “close contact.” The new definition was expanded to account for the cumulative amount of exposure one might have had with a person infected with COVID-19. Under the new definition, close contact is defined as being “within six feet of an infected person for a cumulative total of 15 minutes or more over a 24-hour period beginning two days before illness onset ...
Although the U.S. Department of Justice (DOJ) reported a slight decrease in settlements with life sciences companies in FY2019 (the most recent year for which data is available),[1] this likely will be a temporary trend. Several significant settlements and investigations in 2020 provide key insights into government enforcement priorities as we look toward 2021 ...
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 ...
As the use of telehealth continues to increase, providers need to be mindful of the liability laws in the jurisdictions that they operate in. Similar to in-person medical practices, telehealth services carry liability and malpractice risks. Once a provider virtually crosses a state line, he or she becomes subject to the liability laws of the other state ...
With the continued risk of the spread of COVID-19 in assisted care facilities, more and more facilities are implementing a virtual admissions process. This process includes providing all of the admissions documents, including an arbitration agreement, to potential residents and/or their legal representatives electronically. While it is preferable from a legal standpoint that the arbitration agreement be presented and executed in person, in today's world that is not always possible ...
This 28th edition of Unprecedented, our weekly update on COVID-19-related litigation, includes a number of updates on the mounting number of business interruption coverage disputes -- including a claim against a broker whose alleged failure to obtain infectious disease coverage left the insured without coverage for COVID-19-induced losses ...
In these strange new days of back-to-back virtual meetings, working from home offices, home-schooling children, and social distancing from the grocery store, not to mention from most human beings—who is to say that anyone actually will read these pearls of wisdom from my sweet, dearly departed mother ...
