Prior to the onset of the COVID-19 pandemic, the use of telehealth across Ohio and the United States was steadily increasing. However, out of necessity over the last two years, telehealth has expanded exponentially in order to reduce risks of COVID-19 transmission to practitioners and patients alike. Nearly overnight, the health care community was forced to change the way services were accessed, delivered, and received ...
Trees are ubiquitous. They are a natural part of our landscape and valued for the beauty they provide (not to mention the environmental benefits) as well as their lumber and economic value. Landowners often value their trees, but when a landowner needs to remove trees for development tensions can arise between the government’s interest in preserving and protecting the environment and the landowner’s inherent property rights ...
On Dec. 21, 2021, the Office of Inspector General (OIG) released a Health & Human Services (HHS) OIG Data Brief on genetic tests provided under Medicare Part B. The goal of the OIG in reviewing this data was “to analyze nationwide trends in genetic tests provided and payments made under Medicare Part B.”[1] As a result of this analysis, the OIG determined that there is a significant risk of overuse and misuse of genetic testing ...
Taking agricultural land out of production to offset the impact of nitrate pollution from housing can generate income for its owner and benefit developers and local authorities. The problem Nitrogen and Phosphorus are essential nutrients for plants. Used as fertilisers they boost growth and increase crop yields. They are also a pollutant ...
AstraZeneca AB v. Mylan Pharmaceuticals Inc., Appeal No. 2021-1729 (Fed. Cir. Dec. 8, 2021) Our Case of the Week again focuses on numerical values in claims. Last week we addressed a case involving whether there was written description support for a number in a claim, and we addressed a similar issue the week before. This week, our case focuses on the meaning and scope of a number in a claim ...
On 12 May 2021, Prime Minister Boris Johnson committed to holding a Public Inquiry into COVID-19 that will place "the state's actions under the microscope". Demonstrating that it is independent, objective and fair is fundamental to an Inquiry’s purpose. We take a look at the extent to which the State can effectively examine itself in a Public Inquiry when it has ultimate responsibility for determining the remit, and therefore inevitably the scope of any conclusions ...
Biogen International GMBH v. Mylan Pharmaceuticals Inc., Appeal No. 2020-1933 (Fed. Cir. Nov. 30, 2021) For the second time in two weeks, our Case of the Week focuses on the written description requirement, in particular where the patent claims a range. In fact, all three precedential decisions issued this week concern issues relating to patents that claim numerical ranges. Below, we discuss two of those cases in our “Also This Week” section ...
On Nov. 30, 2021, the U.S. Supreme Court heard oral arguments from a coalition of hospital plaintiffs who are challenging Medicare’s nearly 30% reduction in outpatient drug reimbursement rates for 340B Program-participating hospitals ...
Tennessee healthcare providers now have a very different certificate of need (CON) law to consider when they plan new facilities or expand services. Tennessee's legislature and governor recently enacted the Health Services and Planning Act of 2021 (Public Chapter 557 or "the Act"), which became fully effective Oct. 1, 2021. The Act changes the substantive requirements for CON approval, as well as the application process to obtain a CON ...
1. Introduction Equinor’s pioneering «Hywind Tampen» project, set to become the biggest floating wind farm in the world and scheduled to commence construction in late 2022, will mark the first foray into offshore wind production in Norway. Further, the areas «Utsira Nord» (floating turbines) and «Sørlige Nordsjø II» (bottom fixed turbines), both in the North Sea, have as from 1 January 2021 been opened for development ...
The EU strives to become carbon neutral by 2050. This objective has been formally regulated through the EU Climate Law[i] and is enshrined in the European Green Deal[ii], being also in line with the EU’s commitment to global climate action according to the Paris Agreement[iii] and Glasgow Climate Pact[iv] ...
On October 6, 2021, Governor Gavin Newsom signed Assembly Bill 45 (AB 45) into law. AB 45 permits the manufacture and sale of a wide range of products containing regulated amounts of industrial hemp. Below is a brief overview: What is industrial hemp? “Industrial hemp” is defined as cannabis plants that have no more than 0.3% tetrahydrocannabinol (THC) ...
On Nov. 17, 2021, the United States Drug Enforcement Administration (DEA) released an advanced notice of proposed rulemaking (the Notice) concerning its potential development of telepharmacy regulations ...
On Oct. 19, 2021, the U.S. Food and Drug Administration (FDA) issued a proposed rule that would establish a new category of over-the-counter (OTC) hearing aids. The rule came in response to President Joe Biden’s July 9 executive order, which among other things, calls for wide availability of low-cost hearing aids in order to promote economic competition ...
In order to continue addressing the impacts of COVID-19 on nursing home residents, the Centers for Medicare & Medicaid Services (CMS) recently issued a memo updating guidance for nursing home visitation. You can read the full memo here. Early in the pandemic, CMS implemented visitation restrictions to mitigate the risk of visitors introducing COVID-19 to nursing homes. Now, CMS is updating its guidance and allowing visitation for residents at all times ...
As it draws to a close, COP26 has seen world leaders aim to reach a consensus on actions to keep global warming to 1.5 degrees Celsius and the adoption of electrical vehicles (EV) has been cited as a critical step in achieving that aim. According to data from the Scottish Greenhouse Gas Statistics published by the Scottish Government, the transport sector is the largest emitter of greenhouse gases in Scotland, accounting for around 30% of all emissions ...
On Nov. 8, 2021, the U.S. Department of Health & Human Services Office of the Inspector General (OIG) updated and renamed its Provider Self-Disclosure Protocol. Now called the Health Care Fraud Self-Disclosure Protocol (SDP), the OIG’s revisions are the first changes to the SDP since 2013. We report on the key elements of these changes below ...
Hot off the press, the Department for Business, Energy & Industrial Strategy are today introducing a new Code of Practice, and a draft Commercial Rent (Coronavirus) Bill ...
University of Strathclyde v. Clear-Vu Lighting LLC, Appeal No. 2021-2243 (Fed. Cir. Nov. 4, 2021) In this week’s Case of the Week, the Federal Circuit reversed an inter partes review decision finding claims directed to light-based disinfecting methods to be obvious over the prior art. This case provides a helpful example of how negative claim limitations can affect an obviousness determination ...
