Few areas of law have proven more dynamic over the last few years than the interplay between state tort laws and the federal regulation of pharmaceutical drugs and medical devices. During its last two terms, the United States Supreme Court has issued three separate opinions addressing federal preemption of state law claims under the Federal Food, Drug, and Cosmetic Act ...
Under the CARES Act that was signed into law on March 27, 2020, $100 billion was allocated to “eligible health care providers” to provide financial relief for health care organizations in relation to the COVID-19 public health emergency ...
Last week, a federal jury in South Carolina found that Tuomey Healthcare System, Inc. violated the Stark Law and the False Claims Act by submitting false claims for reimbursement to the United States, resulting in $39 million in damages to the government. United States ex rel. Drakeford v. Tuomey Healthcare Sys., Inc., No. 3:05-2858-MBS (D.S.C. May 8, 2013) ...
Telemedicine and telehealth are newer and ever-expanding components of health care.[1] There are many viable arrangements for companies who wish to engage in telemedicine and/or telehealth and these arrangements can offer many benefits to the patients they serve. However, companies and licensed individuals who provide services should be careful to understand the state and federal regulatory framework under which they operate ...
In June of 2022, the Supreme Court of the United States unanimously held in American Hospital Association v. Becerra that the United States Department of Health and Human Services (“HHS”) and the Centers for Medicare and Medicaid Services (“CMS”) overstepped their statutory authority when cutting 340B-related reimbursements to hospitals from 2018 through 2022 ...
Another wave of COVID-19 has spread all over Thailand and is raising understandable concerns and generating uncertainty among the business community. With our series of infographics, we take this opportunity to guide you on the key measures and best practices to help you mitigate the effects of the COVID-19 pandemic on your business ...
Another wave of COVID-19 has spread all over Thailand and is raising understandable concerns and generating uncertainty among the business community. With our series of infographics, we take this opportunity to guide you on the key measures and best practices to help you mitigate the effects of the COVID-19 pandemic on your business. Today, we highlight 4 practical steps with noteworthy considerations when implementing workforce restructuring options available to employers in Thailand ...
COVID-19 has thrust the world into recession and its rippling effects have given rise to rapid and accelerating changes. Many businesses have moved or expanded into online channels as we collectively begin to embrace and advance headlong into an increasingly digitalized society ...
The curve has flattened, and all fifty states are at least partially reopened. This raises a number of questions about how your facility should proceed with reopening while continuing to protect not only your residents' health, but also their rights. Both failing to meet recommended guidelines and exceeding the guidelines can leave your facility vulnerable for future governmental action and lawsuits ...
August 18, 2022 By: Peter McGaw and John Epperson By now, readers likely are familiar with the series of “retail hazardous waste” enforcement actions being brought across the state of California. For several years, various retailers have been targeted for coordinated, state-wide enforcement by local District Attorneys based on undisclosed, behind-the-scenes “dumpster audits.” These businesses are then accused of disposing of hazardous waste in their trash ...
In the 18th and 19th centuries, the Industrial Revolution produced radical transformations not only in technology, including an ever increasing use of fossil fuels, but also in economic policies and social structure ...
Introduction The World Health Organization named “vaccine hesitancy” as one of the top global health threats in 2019. In the United States, widespread utilization of non-medical exemptions to mandatory vaccination laws has led to statistically significant outbreaks of measles and other vaccine-preventable illnesses, and many headlines forecast that if vaccination exemptions continue the trajectory they are on, this country may well face a public health emergency ...
With the spotlight recently cast upon it by the burgeoning Marcellus and other shale reserve developments, the oil and gas (“O&G”) industry has found itself increasingly the object of regulatory scrutiny. While the majority of commentary and new regulation has focused on the O&G industry’s fracking activities, the heightened regulatory attention has led to new levels of exposure in areas which the industry has traditionally not had extensive entanglement ...
1. Pharmaceutical market players mostly deal with two regulators These are the Ministry of Healthcare of Ukraine (MOH) and the State Administration of Ukraine on Medicinal Products and Narcotic Drugs Control (SAUMP). The MOH is responsible for state registration of medicines, while the SAUMP deals with licensing, evaluation of good manufacturing practice (GMP) compliance, control over quality of medicines, and regulation of medical devices. 2 ...
Flu season is in full swing. with the Center for Disease Control (CDC) confirming over 155,000 positive U.S. cases of influenza since Sept. 29, 2019. Simultaneously, the coronavirus COVID-19 has spread rapidly across China, with at least 70,000 confirmed cases, including 15 confirmed cases in the United States. In response, employers need to be prepared to assist employees in staying safe and complying with potential quarantines. Beginning Feb ...
Dinsmore’s Government Relations team was involved in several significant legislative initiatives affecting the health care sector during the 2019 regular session of the West Virginia legislature. Most notably, Dinsmore was involved in the passage of HB 2010, relating to foster care ...
As a reminder to our life sciences clients including drug manufacturers, medical device manufacturers, and group purchasing organizations, all Open Payments data from the 2020 program year must be reported to CMS by no later than March 31, 2021. Organizations that participate in the Open Payments program are also reminded that they must submit a final attestation that their data is timely, complete and accurate in addition to reporting data from fiscal year 2020 ...
This year it may be easier to predict developments in environmental law and policy than in 2020. The main reason for that is that there are several key developments that should have happened in 2020 but didn’t because of the Covid-19 pandemic. Here are our top five predictions. 1. The Environment Bill The Environment Bill is a key piece of legislation that establishes a post-Brexit environmental governance framework for England ...
After the highlights of the Environment Act 2021 and COP26 in 2021, what does this year hold for environmental law and policy? Here are our top five predictions. 1. The Office for Environmental Protection gets down to work The Office for Environmental Protection (OEP) is a new independent body, established by the Environment Act 2021 (EA 2021), tasked with holding public bodies to account for the environment ...
In recent years, license-in/out transactions have become the most common way for innovative drugs and medical devices (including medical aesthetics) companies to collaboratively develop and commercialize medical products and related technologies. According to public information, in China, the total amount and number of investment and financing in life sciences sector have witnessed a significant decline from 2021 to 2023, with the investment amount being only a quarter of that in 2021 ...
We have recently seen reports about the unbelievable amount of pressure on the NHS, including inaccessibility to GPs; a high degree of emergency admissions; and bed-blocking within hospitals where vulnerable patients cannot be discharged safely. These factors have exacerbated the pressure on our healthcare system to almost unprecedented levels. Medical technologies or MedTech could be the way forward to ease some of the pressure ...
In some ways, the 2023 proxy season might be met with a sigh of relief as some extraneous factors impacting United States capital markets—such as the COVID-19 pandemic and ongoing Russo-Ukrainian conflict—have stabilized in terms of their increased effect. In that same vein, some changes that may have once been viewed as “trends” in disclosure are very much here to stay ...
After a disappointing outcome at COP28 and a weakening of several key net zero policies by the government in 2023, what does 2024 hold for environmental law and regulation? Here are our top 10 things to watch out for. 1. Extended producer responsibility for packaging 2023 saw the introduction of packaging waste data reporting regulations in England, Scotland and Wales ...
1. How do you foresee the evolving regulatory landscape in offshore jurisdictions impacting Asia-based clients in 2024, and what strategies is your firm considering to navigate these changes effectively? Anthony McKenzie (AM): Asia is the world's largest and most populated continent, comprised of many different economies, cultures and laws. The use of Cayman, BVI and Bermuda structures has a long track record throughout Asia and it is this familiarity which has contributed to their popularity ...
