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 ...
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 ...
Nearly 106,000 Americans are currently on waiting lists for donor organs and 17 die each day while waiting. The holy grail for rising to meet this demand and end this suffering will be the ability to “print” the organs, muscles, and tissues from individually grown cells, lowering the need for human donors and the complicated and sometimes unbearable stress that goes along with donor wait lines ...
You may have heard something about GDPR lately and thought "Why should I care? It probably won't affect me or my business.” In reality, the implications of GDPR are far-reaching. The European Union’s General Data Protection Regulation (GDPR) is a set of regulations strengthening data privacy and protection laws for residents of the EU. The regulations take effect in just two months: May 25, to be exact ...
Amid the unprecedented changes wracking the business world in 2020, one certainty remains: many industries will look very different in future years as strategic responses to COVID-19 gain traction and become permanent. In the healthcare REIT sector, we are beginning to see trends that may shape industry norms long after the dust has settled from the chaos of 2020. 1 ...
The impact of COVID-19 and the economic downturn has pressured independent hospitals, rural hospitals and smaller health systems in particular. Despite the immense challenges, independent facilities and their Boards should take this time to best position for the near- and long-term. In light of this, Waller partnered with Kaufman Hall to develop a guide for healthcare leaders, The Health System Growth Imperative: Charting Opportunities During the Pandemic and Beyond ...
On Oct. 22, 2012, the U.S. Court of Appeals for the Ninth Circuit ruled that the Bureau of Land Management and the U.S. Fish and Wildlife Service (FWS) violated the Endangered Species Act (ESA) by granting a right of way for the Ruby Pipeline project. Center for Biological Diversity v. Bureau of Land Management, No. 10-72356 (9th Cir. Oct. 22, 2012) ...
BackgroundIndustrial activities are of great importance to Europe’s financial wealth. Industrial emissions, however, cause environmental pollution and industrial emissions constitute a major part of Europe’s total emissions to air, water and soil. Consequently, there is a need for regulation of industrial operations at an EU level.In view hereof the so-called IPPC Directive (Integrated Pollution Prevention Control) was adopted in 1996 ...
On October 20th, the federal government released a final rule and other companion releases relating to Accountable Care Organizations (ACOs) under the Medicare Shared Savings Program (MSSP), a key component of the Affordable Care Act enacted in March 2010. The proposed rule, issued in March 2011, generated extensive comment from the healthcare industry ...
CMS recently announced yet another delay to the full implementation of “two midnight rule,” which revises its longstanding guidance to hospitals and physicians relating to when hospital inpatient admissions are deemed to be reasonable and necessary for payment under Medicare Part A. Specifically, this latest “delay” is the result of CMS’s extension of the “Probe & Educate Period,” a period of partial non-enforcement for the two midnight rule requirements, until September 30, 2014 ...
