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) ...
The U.S. Department of Justice (DOJ) announced on October 29, 2020 it reached a more than $9.2 million settlement with Medtronic USA Inc. to resolve allegations it violated the False Claims Act (FCA) and Open Payment Program.[1] Specifically, Medtronic agreed to pay $8.1 million to resolve FCA allegations it paid kickbacks to induce a South Dakota neurosurgeon to use its SynchroMed II intrathecal infusion pumps ...
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 ...
In these strange new days of back-to-back vir-tual 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 ...
On September 30, 2020, The Department of Justice (DOJ) announced the results of a sweeping joint healthcare fraud and opioid takedown that resulted in charges against 345 different defendants who were responsible for over $6 billion in government losses involving fraudulent healthcare services and improper billing. This was the largest healthcare fraud enforcement action in the history of the DOJ ...
As a consequence of the spread of COVID-19, certain protection and prevention measures have been developed in order to safeguard health in the different sectors that are operational. In this report we will share security measures implemented in Venezuela aimed at protecting the health of operators and personnel working in ports and at sea, as well as some recommendations established by international organizations. 1 ...
THREE KEY THINGS IN HEALTH CAREFrom the Health Care Practice of Hunton Andrews Kurth LLP HCA Healthcare’s announcement that it will be returning $1.6 billion in Provider Relief Funds illustrates the challenges facing providers in accounting for PRFs under shifting guidance from the Centers for Medicare and Medicaid Services ...
Ohio legislators recently introduced proposed H.B. 679, expanding telehealth services. As a result of the COVID-19 pandemic, telehealth has become more prevalent and necessary. Ohio lawmakers realize telehealth is only going to become more widespread in the future, as patient usage and acceptance continue to grow. If enacted, H.B ...
Key Points Effective Jan. 1, 2021, most California employees — even those who work for very small businesses — will be entitled to 12 weeks of job-protected time off work under the CFRA for qualifying reasons. Qualifying reasons for leave are broadly defined to include caring for a family member — including grandparents, grandchildren, adult children and siblings — with a serious health condition ...
Haynes and Boone, LLP Partner Jason Habinsky talked with Bloomberg Law about labor and employment implications for employers at companies with COVID-19 survivors.Below is an excerpt:Millions of people could be dealing with medical issues including heart, kidney and lung damage long after the pandemic subsides ...
As noted in Part I and Part II of this series, benefits compliance concerns typically take a backseat to the many good reasons for healthcare organizations to provide or receive the services of leased employees. However, with sufficient awareness, these compliance issues, which often have surprisingly outsized risks, can generally be managed without disrupting the aims of the employee leasing arrangement ...
Key Points Starting Jan. 1, 2021, California skilled nursing facilities must have a full-time, dedicated Infection Preventionist. Infection Preventionists must be an RN or LVN, but their hours may not count in minimum direct patient care staffing calculations ...
On September 18th, 2020, the Federal Service for Surveillance in Healthcare (Roszdravnadzor) adopted a new Order approving the criteria for blocking the websites with the content infringing the healthcare regulations. The document establishes criteria for identifying and blocking websites that illegally sale or distribute content that forms a positive image of persons engaged in prohibited retail trade of medicines ...
Key Notes FDA announces flexible approach to enforcement of Nutrition and Supplement Facts labeling requirements for small food manufacturers and manufacturers of packaging for single-ingredient sugars, in part due to the impacts of COVID-19. The FDA adopted final rules updating the Nutrition and Supplement Facts1 labeling requirements (the “Rules”) that are effective on Jan ...
Complementary Law No. 175/2020, enacted in September 23, 2020, determined that the Service Tax (ISS) must be shared between the municipalities where the service providers and the clients are located. Complementary Law No. 175/2020, enacted in September 23, 2020, determined that the Service Tax (ISS) must be shared between the municipalities where the service providers and the clients are located ...
