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 ...
A trademark is any sign which, in the course of trade, can distinguish the goods or services from those of other undertakings. Trademarks are often also used as indications of a certain quality or life style (such as Lancome® trademark represents the luxury cosmetics) or as a marketing tool (such as the IKEA® and VOLVO® marks, which are featured not only on furniture but also on their services) ...
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 ...
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 ...
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 ...
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 ...
Having experienced unprecedented levels of M&A activity in 2021 and the first half of 2022, followed by the market uncertainty of Q3 and Q4 of 2022, what can we expect from the M&A landscape in 2023? Here are some of our key predictions ...
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 ...
As the American press focuses on the dismantling of the Affordable Care Act, the wheels have been set in motion to implement new health care legislation that enjoys strong bipartisan support. The 21st Century Cures Act (the “Act”), signed by President Obama on December 13, addresses a broad range of health care priorities, including drug innovation, biomedical research, and mental health reform ...
The glacial pace at which the federal government has implemented cannabis policy–particularly in light of the rapid evolution of cannabis laws at the state level–is at the same time predictable and frustrating to those seeking a measure of certainty ...
The September 23, 2013 deadline for covered entities, business associates and their subcontractors to implement the new HIPAA rules is approaching quickly. In case you missed it, on January 25, 2013, the U.S. Department of Health and Human Services issued an omnibus final rule modifying the Health Insurance Portability and Accountability Act of 1996 ...
As U.S. hospitals and health clinics continue preparing for novel coronavirus (COVID-19) patient surges, federal regulatory agencies are developing resources to help health care providers comply with myriad regulatory requirements. In this context, the U.S ...
On April 1, 2019, the Health Resources and Services Administration (HRSA) launched a secure website that lists the maximum price drug manufacturers may charge 340B-covered entities for 340B-eligible drug purchases (the 340B Ceiling Price Site). Drug manufacturers and 340B-covered entities may access the 340B Ceiling Price Site through their HRSA Office of Pharmacy Affairs information system (the 340B OPAIS) account here: https://340bopais.hrsa ...
On June 15, 2022, the Supreme Court of the United States released its long-awaited decision in American Hospital Association v. Becerra in which it unanimously held that the United States Department of Health and Human Services (HHS) overstepped its statutory authority by cutting 340B-related reimbursement to hospitals ...
